Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
Status: Active_not_recruiting
Location: See all (62) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
SJHMC Heart and Vascular Institute
Phoenix
Tucson Medical Center
Tucson
California
Scripps Memorial Hospital La Jolla
La Jolla
Cedars-Sinai Medical Center
Los Angeles
UC Davis Medical Center
Sacramento
Kaiser Permanente San Francisco
San Francisco
University of California San Francisco
San Francisco
Stanford University
Stanford
Colorado
Medical Center of the Rockies
Loveland
Florida
Florida Heart & Vascular Care - JFK
Atlantis
The Cardiac & Vascular Institute Research Foundation
Gainesville
NCH Heart Institute
Naples
Georgia
Emory University
Atlanta
Piedmont Heart Institute
Atlanta
Illinois
Northwestern University
Chicago
Indiana
St. Vincent Heart Center of Indiana
Indianapolis
Kansas
Kansas University Medical Center
Kansas City
Ascension Via Christi St. Francis
Wichita
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Maryland
University of Maryland
Baltimore
Michigan
University of Michigan Hospital and Health Systems
Ann Arbor
Henry Ford Health System
Detroit
Minnesota
Mayo Clinic
Rochester
Missouri
Saint Luke's Hospital of Kansas City
Kansas City
North Carolina
University of North Carolina - Chapel Hill
Chapel Hill
Carolinas Medical Center
Charlotte
New Jersey
Morristown Medical Center
Morristown
Rutgers Robert Wood Johnson Medical School
New Brunswick
New York
State University of New York at Buffalo
Buffalo
North Shore University Hospital
Manhasset
Columbia University Medical Center/NYPH
New York
Lenox Hill Hospital
New York
NYU Langone Health
New York
Weill Cornell Medicine-New York Presbyterian Hospital
New York
St. Francis Hospital
Roslyn
Montefiore Medical Center
The Bronx
Ohio
The Christ Hospital
Cincinnati
Cleveland Clinic
Cleveland
Oklahoma
Oklahoma Heart Institute
Tulsa
Oregon
Oregon Health & Science University
Portland
Pennsylvania
University of Pennsylvania
Philadelphia
Lankenau Heart Institute
Wynnewood
Tennessee
Saint Thomas Health
Nashville
Vanderbilt University Medical Center
Nashville
Texas
HCA Houston Healthcare
Houston
The University of Texas Health Science Center at Houston
Houston
Baylor Heart Hopsital Plano
Plano
Utah
Intermountain Medical Center
Murray
Virginia
University of Virginia Health System
Charlottesville
Sentara Norfolk General Hospital
Norfolk
Washington
Swedish Medical Center
Seattle
University of Washington
Seattle
Virginia Mason Franciscan Health
Seattle
Other Locations
Germany
Herz- und Diabeteszentrum NRW, Bad Oeynhausen
Bad Oeynhausen
Herzzentrum Universitätsklinik Bonn
Bonn
Herzzentrum der Uniklinik Köln
Cologne
Herzzentrum Dresden Universitätsklinik
Dresden
Herzzentrum Leipzig GmbH
Leipzig
Johannes Gutenberg-Universität Mainz
Mainz
Klinikum der Universität München - Großhadern
München
Time Frame
Start Date: 2021-04-09
Completion Date: 2030-06-27
Participants
Target number of participants: 1070
Treatments
Experimental: 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
Active_comparator: Optimal Medical Therapy (OMT)
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Experimental: 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
Experimental: 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.
Authors
James McCabe, Bassem Chehab, Mark Russo, Rahul P Sharma, Brian Whisenant, Stanley Chetcuti, James Gammie, Charles Klodell, Cezar S. Staniloae, James Hermiller, Paul Mahoney, Andrew Rassi, Justin Strote, Samir Kapadia, Kamran Muhammad, Vijay Iyer, Joseph Choo, Susheel Kodali, Robert Kipperman, Mackram Eleid, Chad Kliger, Michael Morse, Pinak B Shah, Abhijeet Dhoble, Vasilis Babaliaros, Firas Zahr, Vinod Thourani, William Gray, Sammy Elmariah, Ian Sarembock, Adnan Chhatriwalla, Scott Chadderdon, George A Petrossian, Roger Laham, Brian Lindman, Philipp Lurz, Jörg Hausleiter, Georg Nickenig, Volker Rudolph, Stephan Baldus, Pradeep Yadav, M. Azeem Latib, Mark Reisman, Gorav Ailawadi, Bradley Taylor, Murtaza Dawood, Stephan von Bardeleben, Axel Linke
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences