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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

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

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

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

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

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

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

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

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

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