TRISCEND II Pivotal Trial

• ClinicalTrials.gov Identifier: NCT04482062
• Recruitment Status: Recruiting
• First Posted: July 22, 2020
• Last Update Posted: January 16, 2024
• Sponsor: Edwards Lifesciences
• Information provided by (Responsible Party): Edwards Lifesciences

Study Description

Brief Summary:

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Condition or disease	Intervention/treatment	Phase
Tricuspid Valve Regurgitation; Tricuspid Valve Insufficiency; Tricuspid Valve Disease; Heart Valve Diseases; Cardiovascular Diseases; Heart Failure	Device: Edwards EVOQUE System; Drug: Optimal Medical Therapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1070 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
• Actual Study Start Date: April 9, 2021
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: December 31, 2029

Arms and Interventions

Arm	Intervention/treatment
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	Device: Edwards EVOQUE System; Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT; Other Name: Transcatheter tricuspid valve replacement
Active Comparator: Optimal Medical Therapy (OMT); Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation	Drug: Optimal Medical Therapy; Optimal Medical Therapy
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	Device: Edwards EVOQUE System; Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT; Other Name: Transcatheter tricuspid valve replacement
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.	Device: Edwards EVOQUE System; Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT; Other Name: Transcatheter tricuspid valve replacement

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 6 months ]
   Comparison of number of participants with reduction in TR and composite endpoint event improvement between experimental and active comparator arms
2. Rate of Major Adverse Events (MAE) [ Time Frame: 30 days ]
   Rate of Major Adverse Events (MAE) in experimental arm
3. 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 [ Time Frame: 1 year ]
   Comparison of number of participants with composite endpoint events between experimental and active comparator arms

Secondary Outcome Measures :

1. 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 [ Time Frame: 1 year ]
   Hierarchical comparison of number of participants with composite endpoint events between experimental and active comparator arms

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: TMTT Clinical; 949-250-2500 or 800-424-3278; TMTT_Clinical@Edwards.com

Locations

United States, Arizona

SJHMC Heart and Vascular Institute; Recruiting

Phoenix, Arizona, United States, 85013

Principal Investigator: Hursh Naik, MD

Tucson Medical Center; Recruiting

Tucson, Arizona, United States, 85712

Principal Investigator: Thomas Waggoner, DO

United States, California

Scripps Memorial Hospital La Jolla; Recruiting

La Jolla, California, United States, 92037

Principal Investigator: Curtiss Stinis, MD

Cedars-Sinai Medical Center; Recruiting

Los Angeles, California, United States, 90048

Principal Investigator: Raj Makkar, MD

UC Davis Medical Center; Recruiting

Sacramento, California, United States, 95817

Principal Investigator: Gagan Singh, MD

Kaiser Permanente San Francisco; Recruiting

San Francisco, California, United States, 94118

Principal Investigator: Andrew Rassi, MD

University of California San Francisco; Recruiting

San Francisco, California, United States, 94143

Principal Investigator: Sammy Elmariah, MD

Stanford University; Recruiting

Stanford, California, United States, 94305

Principal Investigator: Rahul P Sharma, MBBS

United States, Colorado

Medical Center of the Rockies; Active, not recruiting

Loveland, Colorado, United States, 80538

United States, Florida

Florida Heart & Vascular Care - JFK; Recruiting

Atlantis, Florida, United States, 33462

Principal Investigator: Marcos Nores, MD

The Cardiac & Vascular Institute Research Foundation; Recruiting

Gainesville, Florida, United States, 32605

Principal Investigator: Charles Klodell, MD

NCH Heart Institute; Recruiting

Naples, Florida, United States, 34102

Principal Investigator: Robert Cubeddu, MD

United States, Georgia

Emory University; Recruiting

Atlanta, Georgia, United States, 30308

Principal Investigator: Vasilis Babaliaros, MD

Piedmont Heart Institute; Recruiting

Atlanta, Georgia, United States, 30309

Principal Investigator: Vinod Thourani, MD

Principal Investigator: Pradeep Yadav, MD

United States, Illinois

Northwestern University; Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator: Charles Davidson, MD

United States, Indiana

St. Vincent Heart Center of Indiana; Recruiting

Indianapolis, Indiana, United States, 46290

Principal Investigator: James Hermiller, MD

United States, Kansas

Kansas University Medical Center; Recruiting

Kansas City, Kansas, United States, 66160

Principal Investigator: Peter Tadros, MD

Cardiovascular Research Institute of Kansas; Recruiting

Wichita, Kansas, United States, 67226

Principal Investigator: Bassem Chehab

United States, Maryland

University of Maryland; Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator: Bradley Taylor, MD

Johns Hopkins Hospital; Withdrawn

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator: Ignacio Inglessis, MD

Brigham and Women's Hospital; Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator: Pinak B Shah, MD

Beth Israel Deaconess Medical Center; Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator: Roger Laham, MD

United States, Michigan

University of Michigan Hospital and Health Systems; Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator: Gorav Ailawadi, MD

Principal Investigator: Stanley Chetcuti, MD

Henry Ford Health System; Recruiting

Detroit, Michigan, United States, 48202

Principal Investigator: Brian P. O'Neill, MD

United States, Minnesota

Mayo Clinic; Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator: Mackram Eleid, MD

United States, Missouri

Saint Luke's Hospital of Kansas City; Recruiting

Kansas City, Missouri, United States, 64111

Principal Investigator: Adnan Chhatriwalla, MD

Washington University Barnes-Jewish Hospital; Withdrawn

Saint Louis, Missouri, United States, 63110

United States, New Jersey

Morristown Medical Center; Recruiting

Morristown, New Jersey, United States, 07960

Principal Investigator: Robert Kipperman, MD

Rutgers Robert Wood Johnson Medical School; Recruiting

New Brunswick, New Jersey, United States, 08903

Principal Investigator: Mark Russo, MD

United States, New York

Montefiore Medical Center; Recruiting

Bronx, New York, United States, 10461

Principal Investigator: M. Azeem Latib, MD

State University of New York at Buffalo; Recruiting

Buffalo, New York, United States, 14203

Principal Investigator: Vijay Iyer, MD

North Shore University Hospital; Recruiting

Manhasset, New York, United States, 11030

Principal Investigator: Bruce Rutkin, MD

NYU Langone Health; Recruiting

New York, New York, United States, 10016

Principal Investigator: Mathew Williams, MD

Principal Investigator: Cezar S. Staniloae, MD

Weill Cornell Medicine-New York Presbyterian Hospital; Recruiting

New York, New York, United States, 10021

Principal Investigator: Mark Reisman, MD

Columbia University Medical Center/NYPH; Recruiting

New York, New York, United States, 10032

Principal Investigator: Susheel Kodali, MD

Lenox Hill Hospital; Active, not recruiting

New York, New York, United States, 10075

Rochester General Hospital; Withdrawn

Rochester, New York, United States, 14621

St. Francis Hospital; Recruiting

Roslyn, New York, United States, 11576

Principal Investigator: George A Petrossian, MD

United States, North Carolina

University of North Carolina - Chapel Hill; Recruiting

Chapel Hill, North Carolina, United States, 27599

Principal Investigator: John Paul Vavalle, MD

Carolinas Medical Center; Recruiting

Charlotte, North Carolina, United States, 28203

Principal Investigator: Mike Rinaldi, MD

United States, Ohio

The Christ Hospital; Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator: Joseph Choo, MD

Cleveland Clinic; Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator: Samir Kapadia, MD

United States, Oklahoma

Oklahoma Heart Institute; Recruiting

Tulsa, Oklahoma, United States, 74104

Principal Investigator: Kamran Muhammad, MD

United States, Oregon

Oregon Health & Science University; Recruiting

Portland, Oregon, United States, 97293

Principal Investigator: Firas Zahr, MD

Principal Investigator: Scott Chadderdon, MD

United States, Pennsylvania

University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator: Howard Hermann, MD

Lankenau Heart Institute; Recruiting

Wynnewood, Pennsylvania, United States, 19096

Principal Investigator: William Gray, MD

United States, Tennessee

Saint Thomas Health; Recruiting

Nashville, Tennessee, United States, 37205

Principal Investigator: Michael Morse, MD

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator: Colin Barker, MD

Principal Investigator: Brian Lindman, MD

United States, Texas

HCA Houston Healthcare; Recruiting

Houston, Texas, United States, 77004

Principal Investigator: Pranav Loyalka, MD

The University of Texas Health Science Center at Houston; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Abhijeet Dhoble, MD

Baylor Heart Hopsital Plano; Recruiting

Plano, Texas, United States, 75093

Principal Investigator: Robert Smith, MD

Principal Investigator: Molly Szerlip, MD

United States, Utah

Intermountain Medical Center; Recruiting

Murray, Utah, United States, 84107

Principal Investigator: Brian Whisenant, MD

United States, Virginia

University of Virginia Health System; Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator: Scott Lim, MD

Sentara Norfolk General Hospital; Recruiting

Norfolk, Virginia, United States, 23507

Principal Investigator: Paul Mahoney, MD

United States, Washington

Virginia Mason Franciscan Health; Recruiting

Seattle, Washington, United States, 98101

Principal Investigator: Ming Zhang, MD

Swedish Medical Center; Recruiting

Seattle, Washington, United States, 98122

Principal Investigator: Sameer Gafoor, MD

University of Washington; Recruiting

Seattle, Washington, United States, 98195

Principal Investigator: James McCabe, MD

Germany

Herz- und Diabeteszentrum NRW, Bad Oeynhausen; Active, not recruiting

Bad Oeynhausen, Germany, 32545

Herzzentrum Universitätsklinik Bonn; Active, not recruiting

Bonn, Germany, 53105

Herzzentrum Dresden Universitätsklinik; Active, not recruiting

Dresden, Germany, 01307

Herzzentrum der Uniklinik Köln; Active, not recruiting

Köln, Germany, 50937

Herzzentrum Leipzig GmbH; Active, not recruiting

Leipzig, Germany, 04289

Johannes Gutenberg-Universität Mainz; Active, not recruiting

Mainz, Germany, 55131

Klinikum der Universität München - Großhadern; Active, not recruiting

München, Germany, 81377

Sponsors and Collaborators

Edwards Lifesciences

Investigators

• Principal Investigator: Rebecca Hahn, MD; Columbia University
• Principal Investigator: Susheel Kodali, MD; Columbia University
• Principal Investigator: Philipp Lurz, MD; Herzzentrum Leipzig GmbH
• Principal Investigator: Vinod Thourani, MD; Piedmont Heart Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kodali S, Hahn RT, George I, Davidson CJ, Narang A, Zahr F, Chadderdon S, Smith R, Grayburn PA, O'Neill WW, Wang DD, Herrmann H, Silvestry F, Elmariah S, Inglessis I, Passeri J, Lim DS, Salerno M, Makar M, Mack MJ, Leon MB, Makkar R; TRISCEND Investigators. Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. JACC Cardiovasc Interv. 2022 Mar 14;15(5):471-480. doi: 10.1016/j.jcin.2022.01.016.

Lurz P, Kresoja KP. Tricuspid Valve Therapies: Closing the Gap. JACC Cardiovasc Interv. 2021 Jun 14;14(11):1241-1242. doi: 10.1016/j.jcin.2021.04.008. No abstract available.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT04482062
• Other Study ID Numbers: 2020-05
• First Posted: July 22, 2020
• Last Update Posted: January 16, 2024
• Last Verified: January 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency; Heart Diseases