TRISCEND II Pivotal Trial

NCT04482062 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2020-05
• Study Type: interventional
• Target: 864
• Locations: 2 countries
• Sites: 62

Brief Summary

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

Conditions

Tricuspid Valve Regurgitation; Tricuspid Valve Insufficiency; Tricuspid Valve Disease; Heart Valve Diseases; Cardiovascular Diseases; Heart Failure

Outcome Measures

Primary Outcomes (16)

• Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction

  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.

  6 months

• 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

  Comparison of number of wins with composite endpoint event improvement between experimental and active comparator arms

  6 months

• Randomized Cohort: Rate of Major Adverse Events (MAE)

  Rate of Major Adverse Events (MAE) in experimental arm (Edwards EVOQUE System \& OMT)

  30 days

• 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

  Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms

  1 year

• Continued Access Study: Rate of Major Adverse Events (MAE)

  Rate of MAEs in the Continued Access Study arm

  30 days

• Continued Access Study: Tricuspid Regurgitation (TR) grade reduction to moderate, mild, or none/trace

  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.

  6 months

• Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  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.

  6 months

• Continued Access Study: New York Heart Association (NYHA) functional class

  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).

  6 months

• Continued Access Study: 6MWD

  6MWD improvement of at least 30 meters

  6 months

• Continued Access Study: All-cause mortality

  Deaths from any cause

  1 year

• Continued Access Study: Durable right ventricular assist device (RVAD) implantation or heart transplant

  Durable RVAD implantation or heart transplant

  1 year

• Continued Access Study: Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention

  Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention.

  1 year

• Continued Access Study: Annualized rate of heart failure hospitalizations

  Annualized rate of heart failure hospitalizations

  1 year

• Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  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.

  1 year

• Continued Access Study: New York Heart Association (NYHA) functional class

  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).

  1 year

• Continued Access Study: 6MWD

  6MWD improvement of at least 30 meters

  1 year

Secondary Outcomes (45)

• 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

Study Arms (4)

Edwards EVOQUE System & OMT

EXPERIMENTAL

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

Optimal Medical Therapy (OMT)

ACTIVE COMPARATOR

Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation

Drug: Optimal Medical Therapy

Single-Arm Registry

EXPERIMENTAL

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

Continued Access Study

EXPERIMENTAL

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

Interventions

Edwards EVOQUE System DEVICE

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT

Also known as: Transcatheter tricuspid valve replacement

Continued Access Study; Edwards EVOQUE System & OMT; Single-Arm Registry

Optimal Medical Therapy DRUG

Optimal Medical Therapy

Optimal Medical Therapy (OMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Patient is pacemaker dependent5 on trans-tricuspid lead without alternative pacing option
• Has delivered appropriate ICD therapy
• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation.
• Active endocarditis within the last 90 days or infection requiring antibiotic therapy (oral or intravenous) within the last 14 days
• Hemodynamically significant pericardial effusion

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (62)

SJHMC Heart and Vascular Institute

Phoenix, Arizona, 85013, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Scripps Memorial Hospital La Jolla

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente San Francisco

San Francisco, California, 94118, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Florida Heart & Vascular Care - JFK

Atlantis, Florida, 33462, United States

Location

The Cardiac & Vascular Institute Research Foundation

Gainesville, Florida, 32605, United States

Location

NCH Heart Institute

Naples, Florida, 34102, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Ascension Via Christi St. Francis

Wichita, Kansas, 67214, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Hospital and Health Systems

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

State University of New York at Buffalo

Buffalo, New York, 14203, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Oregon Health & Science University

Portland, Oregon, 97293, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Lankenau Heart Institute

Wynnewood, Pennsylvania, 19096, United States

Location

Saint Thomas Health

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

HCA Houston Healthcare

Houston, Texas, 77004, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Baylor Heart Hopsital Plano

Plano, Texas, 75093, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Virginia Mason Franciscan Health

Seattle, Washington, 98101, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Herz- und Diabeteszentrum NRW, Bad Oeynhausen

Bad Oeynhausen, 32545, Germany

Location

Herzzentrum Universitätsklinik Bonn

Bonn, 53105, Germany

Location

Herzzentrum der Uniklinik Köln

Cologne, 50937, Germany

Location

Herzzentrum Dresden Universitätsklinik

Dresden, 01307, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Klinikum der Universität München - Großhadern

München, 81377, Germany

Location

Related Publications (4)

• Arnold SV, Hahn RT, Thourani VH, Makkar R, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O'Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran N, Garcia S, Stewart-Dehner T, Grayburn PA, Sannino A, Snyder C, Zhang Y, Mack MJ, Leon MB, Lurz P, Kodali S, Cohen DJ; TRISCEND II Pivotal Trial Investigators. Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial. J Am Coll Cardiol. 2025 Jan 28;85(3):206-216. doi: 10.1016/j.jacc.2024.10.067. Epub 2024 Oct 30.

  PMID: 39480380 DERIVED

• Hahn RT, Makkar R, Thourani VH, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O'Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran NK, Garcia S, Stewart-Dehner T, Thiele H, Kipperman R, Koulogiannis K, Lim DS, Fowler D, Kapadia S, Harb SC, Grayburn PA, Sannino A, Mack MJ, Leon MB, Lurz P, Kodali SK; TRISCEND II Trial Investigators. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. N Engl J Med. 2025 Jan 9;392(2):115-126. doi: 10.1056/NEJMoa2401918. Epub 2024 Oct 30.

  PMID: 39475399 DERIVED

• 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.

  PMID: 35272771 DERIVED

• 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.

  PMID: 34112461 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 22, 2020
• Study Start: April 9, 2021
• Primary Completion: December 5, 2025
• Study Completion (Estimated): June 27, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (55); DE (7)