Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
NCT ID: NCT04097145
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
870 participants
INTERVENTIONAL
2019-12-11
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Edwards PASCAL System & OMT
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
Optimal Medical Therapy (OMT)
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Optimal Medical Therapy
Optimal Medical Therapy alone in patients with tricuspid regurgitation
Single-Arm Registry
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
Continued Access Study
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Interventions
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Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
Optimal Medical Therapy
Optimal Medical Therapy alone in patients with tricuspid regurgitation
Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Martin B. Leon, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Michael J. Mack, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor Scott and White Health
Charles Davidson, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Allen Anderson, MD
Role: STUDY_CHAIR
UT Health San Antonio
Gorav Ailawadi, MD
Role: STUDY_CHAIR
University of Michigan
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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2019-07
Identifier Type: -
Identifier Source: org_study_id