Heart Failure Clinical Trial
Official title:
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
| Status | Recruiting |
| Enrollment | 1070 |
| Est. completion date | December 31, 2029 |
| Est. primary completion date | June 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Symptomatic tricuspid regurgitation (TR) despite medical therapy - TR graded as severe or greater - Appropriate for transcatheter tricuspid valve replacement per the local heart team Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Herz- und Diabeteszentrum NRW, Bad Oeynhausen | Bad Oeynhausen | |
| Germany | Herzzentrum Universitätsklinik Bonn | Bonn | |
| Germany | Herzzentrum Dresden Universitätsklinik | Dresden | |
| Germany | Herzzentrum der Uniklinik Köln | Köln | |
| Germany | Herzzentrum Leipzig GmbH | Leipzig | |
| Germany | Johannes Gutenberg-Universität Mainz | Mainz | |
| Germany | Klinikum der Universität München - Großhadern | München | |
| United States | University of Michigan Hospital and Health Systems | Ann Arbor | Michigan |
| United States | Emory University | Atlanta | Georgia |
| United States | Piedmont Heart Institute | Atlanta | Georgia |
| United States | Florida Heart & Vascular Care - JFK | Atlantis | Florida |
| United States | Johns Hopkins Hospital | Baltimore | Maryland |
| United States | University of Maryland | Baltimore | Maryland |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | State University of New York at Buffalo | Buffalo | New York |
| United States | University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
| United States | Carolinas Medical Center | Charlotte | North Carolina |
| United States | University of Virginia Health System | Charlottesville | Virginia |
| United States | Northwestern University | Chicago | Illinois |
| United States | The Christ Hospital | Cincinnati | Ohio |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | The Cardiac & Vascular Institute Research Foundation | Gainesville | Florida |
| United States | HCA Houston Healthcare | Houston | Texas |
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| United States | St. Vincent Heart Center of Indiana | Indianapolis | Indiana |
| United States | Kansas University Medical Center | Kansas City | Kansas |
| United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
| United States | Scripps Memorial Hospital La Jolla | La Jolla | California |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Medical Center of the Rockies | Loveland | Colorado |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | Morristown Medical Center | Morristown | New Jersey |
| United States | Intermountain Medical Center | Murray | Utah |
| United States | NCH Heart Institute | Naples | Florida |
| United States | Saint Thomas Health | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey |
| United States | Columbia University Medical Center/NYPH | New York | New York |
| United States | Lenox Hill Hospital | New York | 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 | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | SJHMC Heart and Vascular Institute | Phoenix | Arizona |
| United States | Baylor Heart Hopsital Plano | Plano | Texas |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Rochester General Hospital | Rochester | New York |
| United States | St. Francis Hospital | Roslyn | New York |
| United States | UC Davis Medical Center | Sacramento | California |
| United States | Washington University Barnes-Jewish Hospital | Saint Louis | Missouri |
| United States | Kaiser Permanente San Francisco | San Francisco | California |
| United States | University of California San Francisco | San Francisco | California |
| United States | Swedish Medical Center | Seattle | Washington |
| United States | University of Washington | Seattle | Washington |
| United States | Virginia Mason Franciscan Health | Seattle | Washington |
| United States | Stanford University | Stanford | California |
| United States | Tucson Medical Center | Tucson | Arizona |
| United States | Oklahoma Heart Institute | Tulsa | Oklahoma |
| United States | Cardiovascular Research Institute of Kansas | Wichita | Kansas |
| United States | Lankenau Heart Institute | Wynnewood | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Edwards Lifesciences |
United States, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Comparison of number of participants with reduction in TR and composite endpoint event improvement between experimental and active comparator arms | 6 months | |
| Primary | Rate of Major Adverse Events (MAE) | Rate of Major Adverse Events (MAE) in experimental arm | 30 days | |
| Primary | 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 | Comparison of number of participants with composite endpoint events between experimental and active comparator arms | 1 year | |
| Secondary | 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 | Hierarchical comparison of number of participants with composite endpoint events between experimental and active comparator arms | 1 year |
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