There may be more paths forward than you’ve been told.

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

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 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

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