TRISCEND II Pivotal Trial

Running, not enrolling · Not applicable

Conditions studied: Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure

In brief

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

Key facts

Study ID

NCT04482062

Run by

Edwards Lifesciences

People needed

864

Starts

2021-04-09

Expected to finish

2030-06-27

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Significant intra-cardiac mass, thrombus, or vegetation.
• Clinically significant, untreated coronary artery disease requiring revascularization, evidence of acute coronary syndrome, recent myocardial infarction within the last 30 days.
• Any of the following cardiovascular procedures:
• Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days
• Carotid surgery within the last 30 days
• Direct current cardioversion within the last 30 days
• Leadless RV pacemaker implant within the last 30 days
• Cardiac surgery within the last 90 days
• Known history of untreated severe symptomatic carotid stenosis (>50% by ultrasound) or asymptomatic carotid stenosis (>70% by ultrasound)
• Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365days), or any planned percutaneous cardiac procedure within the next 90 days

Where it is running

• 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
• SJHMC Heart and Vascular Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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