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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 (CVD), Heart Valve Diseases, Randomized Controlled Trial (RCT), Severe Heart Valve Disease, Symptomatic Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency, Tricuspid Valve Regurgitation

What it measures

• Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ), The Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. From 23-items, the Overall Summary Score (OSS) will be calculated. In the OSS, each of the 23 items are converted onto a 0 to 100 scale using this formula: (Raw score - Minimum Raw Score)/(Maximum Raw Score - Minimum Raw Score) \* 100. Then these are averaged across the 23 items. A score of 100 (the maximum score) would indicate maximum quality of life relating to heart failure and a score of 0 (scale minimum) would indicate the worst possible quality of life relating to heart failure, with higher scores generally indicating higher quality of life., 12 months post procedure
• Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA), The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure by classifying patients in one of four categories based on their limitations during physical activity and in degree of shortness of breath and or angina pain. Class I is the least severe and Class IV is the most severe. The classes are: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients., 12 months post procedure
• Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention, All-cause mortality, heart failure hospitalization and non-elective tricuspid valve reintervention will be adjudicated by a Clinical Events Committee., 12 months post-procedure
• Composite of major adverse events (MAEs), Composite of major adverse events consist of the following: * Cardiovascular mortality * Stroke * Life-threatening bleeding * Major vascular complications * Major cardiac structural complications * Stage 2 or 3 acute kidney injury * Myocardial infarction or coronary ischemia * Device-related obstruction of forward flow * Device-related pulmonary embolism * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention, 30 days post-procedure

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

Tricuspid Regurgitation (TR)

What it measures

• Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points, All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status., At 30-day follow-up
• Rate of Peri-Procedural Adverse Events, Defined as all-cause mortality, device embolization, device thrombosis, non-elective surgery or transcatheter intervention for device- or procedure-related adverse event (AE) new pacemaker implantation and device- or procedure related major bleeding, Through 30 days post-procedure
• Tricuspid Regurgitation (TR) grade less than or equal to moderate, At 30-day follow-up

Conditions studied

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

What it measures

• Randomized Cohort: Caval Reflux (CR) grade reduction, Reduction in Caval Reflux (CR) assessed by the echocardiography core laboratory. The CR will be assessed using the 3-grade scale: Grade 1 (no reflux, reflux extending for less than 1 cm below the diaphragm), Grade 2 ( reflux extending for less than 3 cm), Grade 3 (reflux of 3 cm or more). Lower grades of CR 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 clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm., 6 months
• Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve surgery or percutaneous tricuspid intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improv, Comparison of clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm., 1 year
• Randomized Cohort: Rate of Major Adverse Events (MAE), Rate of Major Adverse Events (MAE) in experimental arm (TricValve + OMT), 30 days
• Registry Cohort: Rate of Major Adverse Events (MAE), Rate of Major Adverse Events (MAE) in single arm registry, 30 days

Working with

Meditrial USA Inc.

Conditions studied

Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders

What it measures

• Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs, Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs, Baseline to 1 month after implant
• Changes in functional capacity (6-minute walk test), Changes in functional capacity (6-minute walk test), Baseline to 1 month after implant
• Changes in in quality of life (KCCQ score), Changes in in quality of life (KCCQ score). A higher score indicates worsening quality of life outcomes, Baseline to 1 month after implant
• Changes in symptom status (NYHA class), Changes in symptom status (NYHA class), Baseline to 1 month after implant
• The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC)., The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC)., Implant to 30 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

Tricuspid Valve Regurgitation

What it measures

• Absence of device or procedure related major adverse events, 30 days
• Change in TR grade from baseline, 30 days

Conditions studied

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

What it measures

• Freedom from device or procedure related MAEs, * Death * Reintervention * Disabling stroke * Myocardial infarction * Major access site and vascular complications * Severe bleeding * Renal failure requiring dialysis * Major cardiac structural complications * Pulmonary embolism, At 30 days

Conditions studied

Tricuspid Regurgitation

What it measures

• Technical success, Successful valve implantation, During procedure

Conditions studied

Tricuspid Regurgitation Functional

What it measures

• Freedom from device or procedure-related mortality, Freedom from mortality determined to be primarily caused by the device or procedure in the primary endpoint cohort. Events adjudicated by a Clinical Events Committee (CEC)., 30 days post-adjustment

Conditions studied

Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency

What it measures

• Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score), Comparison of number of participants with composite endpoint events between experimental and active comparator arms, 6 months

Conditions studied

Tricuspid Regurgitation

What it measures

• Freedom from device-related complications, Freedom from device-related complications will be determined by assessing the number of participants with procedural, peri-procedural and device-related complications, 30 days after the index procedure
• Reduction in Tricuspid Regurgitation Severity, Tricuspid Regurgitation measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Tricuspid Regurgitation is measured by transthoracic echocardiography in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Change from baseline tricuspid regurgitation severity score 30 days after baseline will be assessed, 30 days after the index procedure

Working with

The Cleveland Clinic, University Hospital, Bordeaux, University of Toronto

Conditions studied

Tricuspid Regurgitation, Tricuspid Regurgitation Functional

What it measures

• Rate of Major Adverse Events [Safety endpoint], Rate of device or procedure-related Major Adverse Events (MAEs) And Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure, at the end of the procedure, at discharge - typically within a week, and 30 days
• Technical Performance, Successful access, delivery, and retrieval of the Trillium™ delivery system, device is anchored both in SVC and IVC \[at the end of the procedure\] And No need for re-intervention due to device valve regurgitation or para-stent leak \[at discharge, and 30 days\], at the end of the procedure, at discharge - typically within a week, and 30 days

Working with

Innoventric Inc.

Conditions studied

Tricuspid Regurgitation (TR)

What it measures

• Rate of Composite Clinical Success, Percentage (%) of participants achieving composite clinical success at 12 months. Composite clinical success is defined as meeting all of the following criteria: Patient survival, Free from heart failure hospitalization, No tricuspid valve surgery or percutaneous intervention, 12 Months Post-Procedure
• Rate of Major Adverse Events (MAE), Rate of Major Adverse Events (MAE) at 30 days consisting of the following components: * Cardiovascular Mortality * Myocardial Infarction (MI), periprocedural and spontaneous * All Stroke, disabling and non-disabling * New need for renal replacement therapy * Severe bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\] * Non-elective tricuspid valve re-intervention, surgery or transcatheter * Major access site and vascular complications * Major cardiac structural complications * Device-related pulmonary embolism * Arrhythmia and conduction disorders requiring permanent pacing, 30 Day Post-Procedure

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

Cardiovascular Diseases, Heart Valve Diseases, Tricuspid Valve Regurgitation

What it measures

• Composite of MAE, Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications., 30 day post-intervention
• Device Success, Device success defined as a reduction in tricuspid regurgitation immediately post-intervention, immediately post-intervention

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

Severe Tricuspid Regurgitation

What it measures

• Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention, 1-year post-procedure
• Rate of Major Adverse Events (MAE), 30-days post-procedure

Conditions studied

Tricuspid Regurgitation

What it measures

• Change in TR from baseline, Change in TR from baseline: reduction in TR grade immediately following implantation as compared to baseline TR grade, based on TEE imaging., During procedure
• Rate of device-related serious adverse events, Rate of device-related serious adverse events, including death (cardiovascular and non- cardiovascular), MI (MVARC definitions), disabling stroke, life-threatening bleeding (MVARC type III-V), renal failure requiring dialysis, emergency surgery, need for additional surgical procedures due to device failure, Up to 30 days
• Rate of procedural success, Procedural success: freedom from emergency surgery or reintervention related to the device or access procedure, without death, stroke, or device dysfunction, Up to 30 days
• Rate of technical success, Technical success: delivery and deployment of the device in the correct position and retrieval of the delivery system., During procedure

Conditions studied

Heart Failure, Interventional Cardiology, Structural Heart Disease, Tricuspid Regurgitation

What it measures

• Mortality Rate, The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group., 1 Year

Conditions studied

Heart Valve Disease, M-TEER, Mitraclip, T-TEER, TAVI, TMVI, TTVI, TriClip

What it measures

• Accuracy of transcatheter AI predictions, Validation of artificial intelligence algorithms for automatic segmentation of anatomic structures and imaging measurements, and prediction of the success of transcatheter interventions. Output of AI algorithm: * Sizes, types, and number of devices to be implanted * Device success * Percentage risk of permanent pacemaker implantation (for TAVI and TTVI) * Percentage risk of 30-day (para)valvular regurgitation for TAVI, and residual regurgitation for M-TEER and T-TEER * Single leaflet detachment for M-TEER and T-TEER * Left ventricular outflow tract obstruction for TMVI. Key success indicators: * First, independent retrospective validation dataset AI algorithms predict procedural outcome with \>90% accuracy and low inter-reader observer variability when compared to measured procedural outcome. * Second independent retrospective dataset, perform a study to validate AI algorithms with \>90% accuracy and low inter-reader observer variability when compared to measured procedural outcome., Preoperative phase: automated segmentation and measurements compared with manual assessments; Postoperative phase at day 30: comparison of predicted results with actual clinical patient outcomes.

Working with

Centre Cardiologique du Nord, Centre Hospitalier Universitaire de Bordeaux, FRANCE, Clinique Pasteur Toulouse, Hospitaux Universitaires Paris Sud, Istituto clinico Città di Brescia, Materialise, Montefiore Medical Center, Pie Medical Imaging, Rennes University Hospital, San Raffaele University Hospital, Italy, Unity Health Toronto, University Hospital, Lille, University Hospital, Marseille, University Medical Center Mainz, Universitätsklinikum Hamburg-Eppendorf, Vancouver Hospital