Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Recruiting now · Not applicable

Conditions studied: Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease

In brief

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Key facts

Study ID: NCT04097145
Run by: Edwards Lifesciences
People needed: 1270
Starts: 2019-12-11
Expected to finish: 2031-12-31
Last updated by the study team: 2026-07-06

Who can join

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

You may qualify if…

Eighteen (18) years of age or older
Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
Severe or greater tricuspid regurgitation
New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team
Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements

You may not qualify if…

Tricuspid valve anatomy not evaluable by TTE or TEE
Tricuspid valve anatomy precludes proper device deployment and function
Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure)
Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:
Would prevent proper TR reduction due to interaction of the lead with the leaflets
Were implanted in the RV within the last 90 days prior to the point of enrollment
Primary non-degenerative tricuspid disease
Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL
Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction
Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment
Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days
Recent Stroke
Active gastrointestinal (GI) bleeding
Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease, including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenic RV
Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days
Any of the following cardiovascular procedures:
Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment
Carotid surgery within 30 days prior to the point of enrollment
Direct current cardioversion within the last 30 days prior to the point of enrollment
Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment
Cardiac surgery within 90 days prior to the point of enrollment
Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis
Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days
Patient is oxygen-dependent or requires continuous home oxygen

Where it is running

Columbia University Irving Medical Center/NYPH — New York, New York, United States (enrolling)
Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset — New York, New York, United States (enrolling)
Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
State University of New York at Buffalo — Buffalo, New York, United States (enrolling)
University of California, Irvine — Irvine, California, United States (enrolling)
Weill Cornell Medicine — New York, New York, United States (enrolling)
Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States (enrolling)
Cooper Health Systems — Camden, New Jersey, United States (enrolling)
Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (enrolling)
The Cardiac and Vascular Institute Research Foundation — Gainesville, Florida, United States (enrolling)
Mount Sinai Medical Center — Miami Beach, Florida, United States (enrolling)
NCH Healthcare System — Naples, Florida, United States (enrolling)
Sarasota Memorial Health Care System — Sarasota, Florida, United States (enrolling)
University of California, San Francisco — San Francisco, California, United States (enrolling)
Emory University Hospital Midtown / Emory University - St. Joseph's Hospital — Atlanta, Georgia, United States (enrolling)
Mayo Clinic — Rochester, Minnesota, United States (enrolling)
Northwestern University — Chicago, Illinois, United States (enrolling)
Ascension St. Vincent Heart Center Cardiovascular Research Institute — Indianapolis, Indiana, United States (enrolling)
St. Joseph Hospital — Denver, Colorado, United States (enrolling)
Morristown Medical Center — Morristown, New Jersey, United States (enrolling)
Johns Hopkins — Baltimore, Maryland, United States (enrolling)
Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
University of Michigan — Ann Arbor, Michigan, United States (enrolling)
St. Francis Hospital — Roslyn, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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