Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
Overview
- Phase
- Not Applicable
- Intervention
- Edwards EVOQUE System
- Conditions
- Tricuspid Valve Regurgitation
- Sponsor
- Edwards Lifesciences
- Enrollment
- 1070
- Locations
- 62
- Primary Endpoint
- Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
Detailed Description
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years old
- •Despite medical therapy (OMT) per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. Patient must be on OMT per the local heart team at the time of TR assessment for trial eligibility (TTE). OMT includes stable oral diuretic medications, unless patient has a documented history of intolerance.
- •Functional and/or degenerative TR graded as at least severe on a transthoracic echocardiogram (assessed by the echo core lab using a 5-grade classification)
- •The Local Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
- •Patient is willing and able to comply with all study evaluations and provides written informed consent.
Exclusion Criteria
- •Anatomy precluding proper device delivery, deployment and/or function
- •LVEF \< 25%
- •Evidence of severe right ventricular dysfunction
- •Any of the following pulmonary pressure parameters:
- •PASP \>60 mmHg by echo Doppler (unless RHC demonstrates PASP ≤70 mmHg)
- •PASP \>70 mmHg by RHC
- •PVR \>5 Wood units by RHC (unless PVR ≤5 Wood units and systolic BP \>85 mmHg after vasodilator challenge)
- •Previous tricuspid surgery or intervention
- •Presence of trans-tricuspid pacemaker or defibrillator lead with any of the following:
- •Implanted in the RV within the last90 days
Arms & Interventions
Edwards EVOQUE System & OMT
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation
Intervention: Edwards EVOQUE System
Optimal Medical Therapy (OMT)
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Intervention: Optimal Medical Therapy
Single-Arm Registry
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
Intervention: Edwards EVOQUE System
Continued Access Study
Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.
Intervention: Edwards EVOQUE System
Outcomes
Primary Outcomes
Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction
Time Frame: 6 months
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.
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
Time Frame: 6 months
Comparison of number of wins with composite endpoint event improvement between experimental and active comparator arms
Randomized Cohort: Rate of Major Adverse Events (MAE)
Time Frame: 30 days
Rate of Major Adverse Events (MAE) in experimental arm (Edwards EVOQUE System \& OMT)
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
Time Frame: 1 year
Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms
Continued Access Study: Rate of Major Adverse Events (MAE)
Time Frame: 30 days
Rate of MAEs in the Continued Access Study arm
Continued Access Study: Tricuspid Regurgitation (TR) grade reduction to moderate, mild, or none/trace
Time Frame: 6 months
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.
Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 1 year
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.
Continued Access Study: New York Heart Association (NYHA) functional class
Time Frame: 1 year
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).
Continued Access Study: 6MWD
Time Frame: 1 year
6MWD improvement of at least 30 meters
Continued Access Study: All-cause mortality
Time Frame: 1 year
Deaths from any cause
Continued Access Study: Durable right ventricular assist device (RVAD) implantation or heart transplant
Time Frame: 1 year
Durable RVAD implantation or heart transplant
Continued Access Study: Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention
Time Frame: 1 year
Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention.
Continued Access Study: Annualized rate of heart failure hospitalizations
Time Frame: 1 year
Annualized rate of heart failure hospitalizations
Secondary Outcomes
- Continued Access Study: Need for paracentesis(1 year, annually through 5 years)
- Randomized cohort: Tricuspid Regurgitation (TR) grade reduction(Time Frame: Discharge (assessed up to 7 days post procedure))
- Randomized cohort: All-Cause Mortality(1 year, annually through 5 years)
- Randomized cohort: Heart failure hospitalizations(1 year, annually through 5 years)
- Randomized cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)(1 year, annually through 5 years)
- Randomized cohort: Durable RVAD implantation or heart transplant(1 year, annually through 5 years)
- Randomized cohort: Need for paracentesis(1 year, annually through 5 years)
- Randomized cohort: Reduction in TR grade by at least one grade(1 year)
- Randomized cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade(1 year)
- Randomized cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline(1 year)
- Randomized cohort: Death and heart failure hospitalization(1 year)
- Randomized cohort: All-cause hospitalizations(1 year)
- Randomized cohort: All-cause mortality(1 year)
- Randomized cohort: Change in 6MWD from baseline(1 year)
- Roll-in cohort: Tricuspid Regurgitation (TR) grade reduction(Time Frame: Discharge (assessed up to 7 days post procedure))
- Roll-in cohort: All-cause mortality(1 year)
- Roll-in cohort: Heart failure hospitalizations(1 year, annually through 5 years)
- Roll-in cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)(1 year, annually through 5 years)
- Roll-in cohort: Durable RVAD implantation or heart transplant(1 year, annually through 5 years)
- Roll-in cohort: Need for paracentesis(1 year, annually through 5 years)
- Roll-in cohort: Reduction in tricuspid regurgitation (TR) grade by at least one grade(1 year)
- Roll-in cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade(1 year)
- Roll-in cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline(1 year)
- Roll-in cohort: Death and heart failure hospitalization(1 year)
- Roll-in cohort: All-cause hospitalizations(1 year)
- Roll-in cohort: Change in 6MWD from baseline(1 year)
- Registry cohort: Tricuspid Regurgitation (TR) grade reduction(Time Frame: Discharge (assessed up to 7 days post procedure))
- Registry cohort: All-cause mortality(1 year)
- Registry cohort: Heart failure hospitalizations(1 year, annually through 5 years)
- Registry cohort: Change in 6MWD from baseline(1 year)
- Registry cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)(1 year, annually through 5 years)
- Registry cohort: Durable RVAD implantation or heart transplant(1 year, annually through 5 years)
- Registry cohort: Need for paracentesis(1 year, annually through 5 years)
- Registry cohort: Reduction in TR grade by at least one grade(1 year)
- Registry cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade(1 year)
- Registry cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline(1 year)
- Registry cohort: Death and heart failure hospitalization(1 year)
- Registry cohort: All-cause hospitalizations(1 year)
- Continued Access Study: Tricuspid Regurgitation (TR) grade reduction(Time Frame: Discharge (assessed up to 7 days post procedure))
- Continued Access Study: All-cause mortality(1 year, annually through 5 years)
- Continued Access Study: Heart failure hospitalizations(1 year, annually through 5 years)
- Continued Access Study: Non-elective tricuspid valve re-intervention (percutaneous or surgical)(1 year, annually through 5 years)
- Continued Access Study: Durable RVAD implantation or heart transplant(1 year, annually through 5 years)