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RECRUITING Not applicable ClinicalTrials.gov

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Sponsor: Edwards Lifesciences • ClinicalTrials.gov ID: NCT04097145

Registry updated: 2026-09-14
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Description

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

Interventions

  • Edwards PASCAL System (Device)
    Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
  • Optimal Medical Therapy (Drug)
    Optimal Medical Therapy alone in patients with tricuspid regurgitation
  • Edwards PASCAL System (Device)
    Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
  • Edwards PASCAL System (Device)
    Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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: 1. Would prevent proper TR reduction due to interaction of the lead with the leaflets 2. 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: 1. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment 2. Carotid surgery within 30 days prior to the point of enrollment 3. Direct current cardioversion within the last 30 days prior to the point of enrollment 4. Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment 5. 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 * Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days) * Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator * Patient is currently participating in another investigational biologic, drug, or device clinical study * Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship * Any patient considered to be vulnerable

Conditions

Tricuspid Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease

Locations

  • Banner University Medical Center Phoenix — Phoenix, Arizona, United States
  • Tucson Medical Center Healthcare — Tucson, Arizona, United States
  • University of California, Irvine — Irvine, California, United States
  • SCPMG - Kaiser San Diego — La Jolla, California, United States
  • Cedars Sinai Medical Center — Los Angeles, California, United States
  • UCLA Medical Center — Los Angeles, 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
  • St. Joseph Hospital — Denver, Colorado, United States
  • Medical Center of the Rockies — Loveland, Colorado, United States
  • The Cardiac and Vascular Institute Research Foundation — Gainesville, Florida, United States
  • Mount Sinai Medical Center — Miami Beach, Florida, United States
  • NCH Healthcare System — Naples, Florida, United States
  • Sarasota Memorial Health Care System — Sarasota, Florida, United States
  • Tallahassee Research Institute — Tallahassee, Florida, United States
  • Emory University Hospital Midtown / Emory University - St. Joseph's Hospital — Atlanta, Georgia, United States
  • Piedmont Healthcare, Inc. — Atlanta, Georgia, United States
  • Northwestern University — Chicago, Illinois, United States
  • Ascension St. Vincent Heart Center Cardiovascular Research Institute — Indianapolis, Indiana, United States
  • University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
  • Ochsner Medical Center — New Orleans, Louisiana, United States
  • Johns Hopkins — Baltimore, Maryland, United States
  • Massachusetts General Hospital — Boston, Massachusetts, United States
  • University of Michigan — Ann Arbor, Michigan, United States
  • Henry Ford Hospital — Detroit, Michigan, United States
  • William Beaumont Hospital - Royal Oak — Royal Oak, Michigan, United States
  • St. Mary's of Ascension Research — Saginaw, Michigan, United States
  • Fairview Health Services — Maplewood, Minnesota, United States
  • Mayo Clinic — Rochester, Minnesota, United States
  • Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Providence St. Patrick Hospital — Missoula, Montana, United States
  • Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
  • Cooper Health Systems — Camden, New Jersey, United States
  • Morristown Medical Center — Morristown, New Jersey, United States
  • Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
  • State University of New York at Buffalo — Buffalo, New York, United States
  • Columbia University Irving Medical Center/NYPH — New York, New York, United States
  • Weill Cornell Medicine — New York, New York, United States
  • Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset — New York, New York, United States
  • Rochester General Hospital — Rochester, New York, United States
  • St. Francis Hospital — Roslyn, New York, United States
  • Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital — The Bronx, New York, United States
  • University of North Carolina — Chapel Hill, North Carolina, United States
  • Sanford Medical Center Fargo — Fargo, North Dakota, United States
  • The Christ Hospital — Cincinnati, Ohio, United States
  • TriHealth-Bethesda North Hospital — Cincinnati, Ohio, United States
  • The Ohio State University — Columbus, Ohio, United States
  • Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
  • Oklahoma Cardiovascular Research Group — Oklahoma City, Oklahoma, United States
  • Oklahoma Heart Institute at Hillcrest Medical Center — Tulsa, Oklahoma, United States
  • Oregon Health & Science University — Portland, Oregon, United States
  • Penn State Hershey — Hershey, Pennsylvania, United States
  • Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
  • Pinnacle Health Cardiovascular Institute/UPMC Pinnacle — Wormleysburg, Pennsylvania, United States
  • Lankenau Heart Institute — Wynnewood, Pennsylvania, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Erlanger Health System — Chattanooga, Tennessee, United States
  • Vanderbilt University Medical Center — Nashville, Tennessee, United States
  • HCA Houston Healthcare Medical Center — Houston, Texas, United States
  • Baylor College of Medicine St. Luke's Medical Center — Houston, Texas, United States
  • The University of Texas Health Science Center at Houston — Houston, Texas, United States
  • UTHealth/Memorial Hermann Hospital — Houston, Texas, United States
  • Baylor Scott & White - The Heart Hospital - Plano — Plano, Texas, United States
  • Intermountain Medical Center — Murray, Utah, United States
  • St. George Regional Hospital — St. George, Utah, United States
  • University of Virginia Health System — Charlottesville, Virginia, United States
  • Virginia Commonwealth University — Richmond, Virginia, United States
  • Carilion Medical Center — Roanoke, Virginia, United States
  • Virginia Mason Medical Center — Seattle, Washington, United States
  • Swedish Medical Center — Seattle, Washington, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • St. Paul's Hospital — Vancouver, British Columbia, Canada
  • Hamilton Health Services — Hamilton, Ontario, Canada
  • University of Ottawa Heart Institute — Ottawa, Ontario, Canada
  • Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
  • St. Michael's Hospital — Toronto, Ontario, Canada
  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec, Quebec, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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