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Conditions studied

Aortic Stenosis

What it measures

• Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort., Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis. \* Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition., Participants will be followed for the duration of hospital stay through 1 year.

Conditions studied

Degenerative Mitral Valve Disease, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Regurgitation

What it measures

• PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs)., 30 days.
• PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort., 6 months
• PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only., From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up

Conditions studied

Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Replacement, Aortic Valve Stenosis

What it measures

• Debris capture, defined as the average number of captured particles ≥150 µm in diameter, as assessed by independent histologic analysis, The co-primary filtration efficacy endpoint is debris capture, defined as the average number of captured particles ≥150 μm in diameter, as assessed by independent histologic analysis., Evaluated at the time of the TAVR procedure (during the intervention/procedure)
• Incidence of the composite of all-cause mortality, all stroke (disabling or non-disabling) and transient ischemic attack (TIA), and Acute Kidney Injury Stage 2 or 3 (including renal replacement therapy), according to VARC-2 definitions, The primary safety and efficacy endpoint is combined safety and efficacy at 30 days, defined as a composite of the following VARC-2 defined components: * All-cause mortality * All stroke (disabling or non-disabling) and transient ischemic attack (TIA) * Acute Kidney Injury Stage 2 or 3 (including renal replacement therapy), Evaluated at 30-day post-procedure (TAVR) follow-up visit

Working with

Yale Cardiovascular Research Group

Conditions studied

Bicuspid Aortic Valve

What it measures

• Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure., Device success rate, defined as: * Absence of procedural mortality, AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days), 7 days
• Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure., Rate of of all-cause mortality or disabling stroke rate at 30 days, 30 days

Conditions studied

Severe Aortic Stenosis

What it measures

• All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability, All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline., 24 months

Conditions studied

Cardiovascular Diseases, Heart Failure, Heart Valve Diseases, Tricuspid Valve Disease, Tricuspid Valve Insufficiency, Tricuspid Valve Regurgitation

What it measures

• Continued Access Study: 6MWD, 6MWD improvement of at least 30 meters, 1 year
• Continued Access Study: 6MWD, 6MWD improvement of at least 30 meters, 6 months
• Continued Access Study: All-cause mortality, Deaths from any cause, 1 year
• Continued Access Study: Annualized rate of heart failure hospitalizations, Annualized rate of heart failure hospitalizations, 1 year
• Continued Access Study: Durable right ventricular assist device (RVAD) implantation or heart transplant, Durable RVAD implantation or heart transplant, 1 year
• Continued Access Study: New York Heart Association (NYHA) functional class, NYHA functional class improvement of at least 1 class. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest)., 1 year
• Continued Access Study: New York Heart Association (NYHA) functional class, NYHA functional class improvement of at least 1 class. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest)., 6 months
• Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), Improvement in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL., 1 year
• Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), Improvement in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL., 6 months
• Continued Access Study: Rate of Major Adverse Events (MAE), Rate of MAEs in the Continued Access Study arm, 30 days
• Continued Access Study: Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention, Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention., 1 year
• Continued Access Study: Tricuspid Regurgitation (TR) grade reduction to moderate, mild, or none/trace, TR grade reduction to moderate, mild, or none/trace from baseline. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential); Lower grades of TR are better., 6 months
• Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement, Comparison of number of wins with composite endpoint event improvement between experimental and active comparator arms, 6 months
• Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6MWD improvement, Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms, 1 year
• Randomized Cohort: Rate of Major Adverse Events (MAE), Rate of Major Adverse Events (MAE) in experimental arm (Edwards EVOQUE System \& OMT), 30 days
• Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction, Comparison of number of participants with reduction in TR between experimental and active comparator arms. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better., 6 months

Conditions studied

Tricuspid Regurgitation, Tricuspid Valve Disease

What it measures

• Emergency surgery or intervention related to the device/procedure complications, Number of days until emergency surgery or intervention, 1 Month
• Heart Failure Events, Number of heart failure episodes including hospitalization, or worsening heart failure, 12 Months
• Kansas City Cardiomyopathy Questionnaire (KCCQ) Score, Change in KCC score (score ranges between 0 and 100), 12 Months
• Major vascular, access-related, or cardiac structural complication, Number of days until death, 1 Month
• Mortality, Number of days until death, 1 Month and 12 Months
• New York Heart Association (NYHA class), Change in NYHA class (range from I to IV), 12 Months
• Pulmonary Embolism, Number of days until death, 1 Month
• Right Ventricular Assist Device (RVAD) implantation or heart transplant, Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant, 12 Months
• Six Minute Walking Test (6MWT), Change in walking distance, 12 Months
• Stage 3 Acute Kidney Injury with increase in serum creatinine >300% (>3.0x increase) and/or serum creatinine ≥4.0mg/dL (≥354 μmol/L) with an acute increase of ≥ 0.5 mg/dL (≥44 μmol/L), Number of days from baseline until increase, 7 Days
• Stage 4 Acute Kidney Injury requiring new temporary or permanent renal replacement therapy, Number of days until new renal replacement therapy, 1 Month
• Stroke, Number of days until death, 1 Month
• Tricuspid valve surgery or percutaneous tricuspid intervention, Number of days until tricuspid valve surgery or percutaneous tricuspid intervention, 12 Months
• Valve Academic Research Consortium (VARC) type 2-4 bleeding complication, Number of days until death, 1 Month

Working with

Meditrial USA Inc., P+F Products + Features GmbH

Conditions studied

Cardiovascular Diseases, Heart Valve Diseases, Tricuspid Valve Regurgitation

What it measures

• Clinical Success, Procedural success without MAEs at 30 days., 30 Days
• Composite Major Adverse Events (MAEs), Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days., 30 Days
• Device Success, Study device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory., Intraprocedural
• Procedure Success, Device success without clinically significant paravalvular leak (PVL) on a transthoracic echocardiogram (assessed by the echo core lab) at time of discharge., Discharge (Up to 7 days post procedure)
• Tricuspid Regurgitation Reduction, Percentage of patients with at least 1 grade reduction in tricuspid regurgitation (TR) as measured by using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory., Discharge (Up to 7 days post procedure)

Conditions studied

Cardiovascular Diseases, Mitral Regurgitation Functional, Mitral Valve Disease

What it measures

• Primary Safety Endpoint, The composite (aggregate) of the following implant-related and/or delivery-related serious adverse events (SAEs) at 30 days post index procedure (based on MVARC definitions and adjudicated by an independent clinical events committee). The unit of outcome measure is % (n/N): * Mortality: all-cause * Stroke: disabling and non-disabling; Bleeding: life-threatening based MVARC scale * Major access site vascular complications * Major cardiac structural complications due to access-related issues * Acute kidney injury (AKI; ≤7 days post index procedure): based on the Acute Kidney Injury Network (AKIN) --System Stage 3 (including renal replacement therapy) or Stage 2 * Myocardial infarction (MI; periprocedural \[≤48 hours\] or spontaneous \[\>48 hours\]) * Coronary ischemia requiring percutaneous coronary intervention (PCI) or coronary artery bypass graft * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention, 30 days post index procedure
• Primary Technical Success Endpoint, Technical Success (measured at exit from the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC ). All of the following must be present: Absence of procedural mortality; and Successful access, delivery and retrieval of the device delivery system; and Successful deployment and correct positioning of the first intended device; and Freedom from emergency surgery or reintervention related to the device or access procedure., Index procedure exit from the catheterization laboratory

Conditions studied

Complex Congenital Heart Defect, Pulmonary Regurgitation, Pulmonary Valve Insufficiency, RVOT Anomaly, Tetralogy of Fallot

What it measures

• Acute Device Success, Acute Device Success, defined as a non-hierarchical composite of: * Single Alterra deployed in the desired location * Single THV implanted in the desired location within Alterra * Right ventricle-pulmonary artery peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation (PR) by discharge transthoracic echocardiogram * Free of Alterra/SAPIEN 3 explant at 24 hours post-implantation, 24 hours post-procedure

Conditions studied

Congenital Heart Disease, Pulmonary Disease, Pulmonary Regurgitation, Tetralogy of Fallot, Transcatheter Pulmonary Valve Replacement (TPVR)

What it measures

• Main Cohort: THV Dysfunction, Number of patients with THV dysfunction, defined as a non-hierarchical composite of: * RVOT/PV Reintervention * Moderate or greater total Pulmonic Regurgitation via Transthoracic Echocardiography (TTE) * Mean RVOT/PV Gradient \>= 35mmHg via TTE, 6 months
• PDS Registry: Acute PDS Success, Number of patients with acute PDS success, defined as a non-hierarchical composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation by discharge TTE (or earliest evaluable TTE) * Free of SAPIEN 3 / Alterra explant at 24 hours post-implantation, 24 hours

Conditions studied

Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Degeneration, Pulmonary Valve Insufficiency, Pulmonary Valve; Obstruction

What it measures

• Device Success, Defined as a composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery peak-to-peak gradient \< 35 mmHg post-implantation * Less than moderate PR by discharge TTE * Free of explant at 24 hours post-implantation, Discharge, expected to be within 1-5 days post-procedure

Conditions studied

Tricuspid Regurgitation

What it measures

• Primary Performance Endpoint - Clinical Success, Number of patients who had Clinical Success at 30 days and 1 year, definition modified from TVARC criteria. Per patient analysis., 30 days and 1 year
• Primary Performance Endpoint - Intraprocedural Success, Number of patients who had Intraprocedural Success, definition modified from TVARC criteria. Per patient analysis., Intraprocedural
• Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate, Number and percentage of patients who experienced at least one major adverse event (MAE)., 30 days

Conditions studied

Cardiovascular Diseases, Degenerative Mitral Valve Disease, Functional Mitral Regurgitation, Heart Valve Diseases, Mitral Insufficiency, Mitral Regurgitation, Mitral Valve Insufficiency, Valve Disease, Heart

What it measures

• Percentage of Participants With Freedom From All-cause Mortality and Heart Failure Hospitalization (HFH), The primary endpoint for the Severe MAC cohort is freedom from all-cause mortality and heart failure hospitalization (HFH), evaluated against a performance goal of 43%., 12 months post index procedure

Conditions studied

Aortic Stenosis, Severe, Heart Diseases

What it measures

• All-cause death, all stroke, and unplanned cardiovascular hospitalization, The number of patients that have any of these conditions, When all patients have reached 2-year follow-up

Conditions studied

Symptomatic Severe Aortic Stenosis

What it measures

• Device success, Intended performance of the valve, 30 days
• Technical success, Successful access, delivery of the Abbott BE TAVI valve, and retrieval of the delivery system., From start of procedure up to end of procedure

Conditions studied

Aortic Valve Disease, Aortic Valve Stenosis

What it measures

• Primary Effectiveness Endpoint: Hemodynamic Performance Assessment, Hemodynamic performance parameters are mmHG mean gradient and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (Effective Orifice Area (EOA)) at one year based on literature reports for surgical aortic valve replacement., 12 months following patient enrollment completion
• Primary Effectiveness Endpoint: New York Heart Association Improvement Assessment, Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification status at 365 days compared to baseline. a. Class I - No symptoms and no limitations in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. b. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. c. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. d. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients., 12 months following patient enrollment completion
• Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments, The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard. a. Thromboembolism b. Valve Thrombosis c. Major Paravalvular leak d. Major Hemorrhage e. Endocarditis, 12 months following patient enrollment completion
• Primary Safety Endpoints: Surgical Valve Events Rate Assessment, The rates of other events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature. a. All-caused death b. Valve related death c. Valve-related reoperation d. Valve explant e. Hemorrhage f. All-cause reoperation g. Valve-related death, 12 months following patient enrollment completion

Conditions studied

Mitral Valve Regurgitation (Degenerative or Functional)

What it measures

• Composite of major adverse events, Proportion of patients with major adverse events, 30 days

Conditions studied

Moderate Aortic Valve Stenosis

What it measures

• Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention., Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV., 30 days
• Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention., 2 years

Conditions studied

Aortic Valve Stenosis

What it measures

• All-cause Death, Number of participants that died, 1 year

Conditions studied

Aortic Regurgitation, Aortic Valve Disease, Aortic Valve Insufficiency

What it measures

• Number of patients that do not experience death or disabling stroke, Freedom from death or disabling stroke Disabling stroke is evaluated using a standardized scale, 30 days after the valve procedure

Conditions studied

Aortic Valve Stenosis

What it measures

• Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study, Assessment of procedural safety by: All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling stroke: a modified rankin score (mRS) of 2 or more at 90 days post-stroke and an increase of at least one mRS category from an individual's pre-stroke baseline. All stroke: any stroke after valve intervention (ischemic, hemorrhagic, or undetermined stroke)., Randomized Controlled Trial - 24 months Continued Access Study - 12 months

Conditions studied

Mitral Valve Regurgitation

What it measures

• All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded), The proportion of subjects who are alive, without stroke, CV hospitalization or acute kidney injury requiring renal replacement therapy at 2 years in the Device and Control groups, respectively, 2 Years
• Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous), Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) from the time of index procedure through 2 years in the Device and Control groups, respectively, 2 Years

Conditions studied

Aortic Stenosis

What it measures

• All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure), Number of patients that had any of these events, 1 year

Conditions studied

Mitral Valve Regurgitation

What it measures

• All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) composite score., All-cause mortality, valve re-intervention, hospitalizations/urgent visits for heart failure (without a blanking period), or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) from randomization to a minimum of 3 years post intervention. Composite score will be expressed as a Z-score - The Z-Score is a statistical measurement of a score's relationship to the mean in a group of scores. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher than the mean., 3 years post intervention

Working with

National Heart, Lung, and Blood Institute (NHLBI)

Conditions studied

Symptomatic Severe Aortic Stenosis

What it measures

• Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak, Number of participants with moderate or greater paravalvular leak at 30 days., at 30 days
• Primary Safety Endpoint is All-cause Mortality, All-cause mortality is defined as the total number of deaths in each cohort at 30 days., at 30 days

Conditions studied

Aortic Valve Stenosis

What it measures

• Percentage of Patients With Major Vascular Complications (Primary Safety Endpoint- FlexNav Delivery System Study), Valve Academic Research Consortium (VARC) 2- defined major vascular complications, 30 days from index procedure
• Primary Effectiveness Endpoint (Randomized IDE Cohort), A composite of all-cause mortality or disabling stroke at one year., One-year from randomization
• Primary Safety Endpoint (Randomized IDE Cohort), Non-hierarchical composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days., 30 days from randomization

Conditions studied

Mitral Disease, Mitral Regurgitation

What it measures

• Technical Success, Defined as meeting all the following: * Alive * Successful access, delivery and retrieval of the delivery systems * Deployment of the devices in the intended position * Freedom from emergency surgery or reintervention related to the device or access procedure, At the end of the procedure

Conditions studied

Aortic Valve Replacement, Aortic Valve Stenosis, Symptomatic Aortic Stenosis

What it measures

• Bioprosthetic Valve Dysfunction (BVD), Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve)), 12 months
• Mortality, Disabling Stroke or Heart Failure Rehospitalization, Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization., 12 months

Conditions studied

Aortic Stenosis Symptomatic

What it measures

• All-cause mortality or disabling stroke, Mortality will be reported as rate of death/mortality at 30 days. Disabling stroke will be reported according to Valve Academic Research Consortium (VARC-3) Guidelines, 30 Days
• Technical success of implantation of the Siegel TAVR, Technical success will be reported as freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device., Immediate post procedure

Conditions studied

Aortic Regurgitation

What it measures

• All-Cause Mortality at 30 days, All-Cause mortality within the first 30 days post index procedure, 30 days

Conditions studied

Tricuspid Regurgitation

What it measures

• For Randomized Cohort: Hierarchical Composite of All-cause Death or Tricuspid Valve Surgery, Heart Failure Hospitalizations, and KCCQ Improvement, Analysis of hierarchical composite of all-cause death or tricuspid valve surgery, heart failure hospitalizations, and KCCQ improvement of at least 15 points was performed in ITT population using Finkelstein-Schoenfeld method. A win ratio was also calculated to descriptively quantify the magnitude of treatment benefits. The win ratio is calculated as the ratio of the number of wins in Device versus Control patients. The primary analysis population consisted of 175 Device patients and 175 Control patients, resulting in 30,625 Device-Control patient pairs (i.e., 175 × 175)., 12 Months
• For Single-Arm Cohort: Rate of Survival Through 12 Months With a Quality of Life Improvement (Assessed Using KCCQ Overall Score) of at Least 10 Points Compared to Baseline., This outcome will be assessed as the percentage of subjects meeting the definition of the endpoint., 12 months

Conditions studied

Tricuspid Regurgitation

What it measures

• Rate of implant or delivery related serious adverse events, Rate of implant or delivery related serious adverse events, Through 30 days post-procedure

Conditions studied

Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Disease, Aortic Valve Insufficiency, Left Ventricular Dysfunction

What it measures

• Acute Kidney Injury, Number of patients that had acute kidney injury (AKI) stage 3 or 4, 30 days
• All Stroke, Number of patients that had stroke, 30 days
• All-cause mortality, All-cause mortality within the first 30 days post index procedure, 30 days
• Bleeding, Freedom from VARC type 2-4 bleeding, 30 days
• Device Performance, Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)\*, 30 days
• Device Positioning, Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location, 30 days
• Device Success, Freedom from unsuccessful delivery of the device, and retrieval of the delivery system, 30 days
• Major Vascular Complication, Number of patients that had major vascular, access-related, or cardiac structural complication, 30 days
• Permanent pacemaker implantation, Number of patients that had these events, 30 days
• Surgery/intervention related to device, Freedom from surgery or intervention related to the device# or to a major vascular or access-related or cardiac structural complication, 30 days
• Total aortic regurgitation, Number of patients that had moderate or severe total aortic regurgitation, 30 days

Conditions studied

Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Disease, Aortic Valve Insufficiency

What it measures

• Acute Kidney Injury, Number of patients that had these events, 30 days
• All Stroke, Number of patients that had a stroke, 30 days
• All-Cause Mortality at 1 Year, All-cause mortality within the first 12 months post index procedure, 1 year
• Major Bleeding, Number of patients that had any of these events, 30 days
• Major Vascular Complications, Number of patients that had these events, 30 days
• Permanent pacemaker implantation, Number of patients that had these events, 30 days
• Surgery/intervention related to the device, Number of patients that had these events, 30 days
• Total aortic regurgitation, Number of patients that had these events, 30 days

Conditions studied

Congenital Heart Disease, Pulmonary Regurgitation, RVOT Anomaly, Tetrology of Fallot

What it measures

• Freedom From Procedure- or Device-related Mortality at 30 Days., The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure., 30 days
• Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months, Defined as: * Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND- * Pulmonary regurgitant fraction as measured by magnetic resonance imaging \<20%, 6 months

Conditions studied

Tricuspid Regurgitation (TR)

What it measures

• Primary Outcome - Incidence of major adverse events at 30 days post procedure, A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure, as listed below: * Cardiovascular Death * Myocardial Infarction (MI) * Stroke * New Onset Renal Failure Requiring Unplanned Dialysis or Hemofiltration * Major Bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\]) * Tricuspid Valve Surgery or Transcatheter Re-intervention post Procedure * Major Access Site and Vascular Complications * Major Cardiac Complications * Device-related Pulmonary Embolism * New Pacemaker Implantation due to Atrioventricular (AV) Block, at 30 days post procedure
• Primary Outcome - Post-procedural TR Remission Rate, Defined as: Post-procedural TR of moderate or less (TR≤2+) without clinically significant paravalvular leak (PVL) on a transthoracic echocardiography (TTE) at 30 days post- procedure (Assessed by the Echocardiography Core Lab using a 5-grade classification), at 30 days post procedure

Working with

Cardiovascular Research Foundation, New York

Conditions studied

Aortic Valve Stenosis

What it measures

• All-Cause Death, Hierarchical occurrence within efficacy assessment time interval (EATI) of:, 12 months
• Change in KCCQ relative to baseline, Hierarchical occurrence within efficacy assessment time interval (EATI) of:, 12 months
• Disabling Stroke, Hierarchical occurrence within efficacy assessment time interval (EATI) of:, 12 months
• Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent)., Hierarchical occurrence within efficacy assessment time interval (EATI) of:, 12 months

Working with

Avania, Cardialysis BV

Conditions studied

Mitral Valve Insufficiency

What it measures

• Percent of Subjects With Adverse Events, PILOT: Site Reported Serious Adverse Events Implant or Delivery Related Through 30-Days EFS: Implant, Delivery or device related serious adverse events through 30 days post procedure, 30 days

Conditions studied

Aortic Stenosis, Aortic Valve Calcification, Severe Aortic Valve Stenosis, Symptomatic Aortic Stenosis

What it measures

• All-cause mortality or disabling stroke, Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines, 30days
• Technical success, Freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device., Immediate post procedure

Conditions studied

Mitral Regurgitation

What it measures

• Change in NYHA classification from Baseline to 5 years, The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest., Baseline compared to 1 and 5 years

Conditions studied

Heart Defects, Congenital, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Tetralogy of Fallot

What it measures

• Valve-related mortality and device-related re-intervention, The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure, 6 months

Conditions studied

Congenital Heart Disease, Pulmonary Regurgitation, RVOT Anomaly, Tetrology of Fallot

What it measures

• Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:, * Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND * Pulmonary regurgitant fraction as measured by CMR \<20%, 6 months

Conditions studied

Heart Failure, Mitral Regurgitation

What it measures

• Number of Occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE), Number occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE) defined as: * All cause death * Stroke and paradoxical embolism * Myocardial infarction * V-Wave shunt device embolization * Cardiac tamponade * Device related re-intervention or surgery, Up to1 month post implant

Working with

V-Wave Ltd