TRISCEND II Pivotal Trial
- Conditions
- Cardiovascular DiseasesTricuspid Valve InsufficiencyHeart Valve DiseasesTricuspid Valve RegurgitationTricuspid Valve DiseaseHeart Failure
- Interventions
- Drug: Optimal Medical TherapyDevice: Edwards EVOQUE System
- Registration Number
- NCT04482062
- Lead Sponsor
- Edwards Lifesciences
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1070
- Symptomatic tricuspid regurgitation (TR) despite medical therapy
- TR graded as severe or greater
- Appropriate for transcatheter tricuspid valve replacement per the local heart team
- Tricuspid valve anatomic contraindications
- Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
- Hemodynamic instability
- Refractory heart failure requiring advanced intervention
- Currently participating in another investigational study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optimal Medical Therapy (OMT) Optimal Medical Therapy Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation Continued Access Study Edwards EVOQUE System 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. Edwards EVOQUE System & OMT Edwards EVOQUE System Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation Single-Arm Registry Edwards EVOQUE System 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
- Primary Outcome Measures
Name Time Method TR Grade reduction and composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement 6 months Comparison of number of participants with reduction in TR and composite endpoint event improvement between experimental and active comparator arms
Rate of Major Adverse Events (MAE) 30 days Rate of Major Adverse Events (MAE) in experimental arm
Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6-minute walk distance improvement 1 year Comparison of number of participants with composite endpoint events between experimental and active comparator arms
- Secondary Outcome Measures
Name Time Method Composite endpoint including reduction in TR grade, change in QOL from baseline, death and heart failure hospitalization, all-cause hospitalization, all-cause mortality, and change in right ventricular end diastolic volume index 1 year Hierarchical comparison of number of participants with composite endpoint events between experimental and active comparator arms
Trial Locations
- Locations (62)
SJHMC Heart and Vascular Institute
🇺🇸Phoenix, Arizona, United States
Tucson Medical Center
🇺🇸Tucson, Arizona, United States
Scripps Memorial Hospital La Jolla
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Kaiser Permanente San Francisco
🇺🇸San Francisco, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
Florida Heart & Vascular Care - JFK
🇺🇸Atlantis, Florida, United States
The Cardiac & Vascular Institute Research Foundation
🇺🇸Gainesville, Florida, United States
NCH Heart Institute
🇺🇸Naples, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
St. Vincent Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Ascension Via Christi St. Francis
🇺🇸Wichita, Kansas, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan Hospital and Health Systems
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
State University of New York at Buffalo
🇺🇸Buffalo, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
Weill Cornell Medicine-New York Presbyterian Hospital
🇺🇸New York, New York, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Lankenau Heart Institute
🇺🇸Wynnewood, Pennsylvania, United States
Saint Thomas Health
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
HCA Houston Healthcare
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Baylor Heart Hopsital Plano
🇺🇸Plano, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Virginia Mason Franciscan Health
🇺🇸Seattle, Washington, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
University of Washington
🇺🇸Seattle, Washington, United States
Herz- und Diabeteszentrum NRW, Bad Oeynhausen
🇩🇪Bad Oeynhausen, Germany
Herzzentrum Universitätsklinik Bonn
🇩🇪Bonn, Germany
Herzzentrum Dresden Universitätsklinik
🇩🇪Dresden, Germany
Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Klinikum der Universität München - Großhadern
🇩🇪München, Germany
Herzzentrum der Uniklinik Köln
🇩🇪Köln, Germany
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Germany