Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

NCT04097145 | Recruiting DMC FDA Device

• 1 other identifier: 2019-07
• Study Type: interventional
• Target: 870
• Locations: 2 countries
• Sites: 79

Brief Summary

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

Conditions

Tricuspid Regurgitation; Tricuspid Valve Disease; Tricuspid Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

• Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score)

  Comparison of number of participants with composite endpoint events between experimental and active comparator arms

  12 months

Secondary Outcomes (14)

• 1 Grade Reduction in TR Severity

  6, 12 months

• Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

  3, 6, and 12 months

• All Cause Mortality

  12 months, 24 months

• Death and Heart Failure Hospitalizations

  12 months

• All-cause Hospitalization

  12 months

Study Arms (4)

Edwards PASCAL System & OMT

EXPERIMENTAL

Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Device: Edwards PASCAL 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 repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization

Device: Edwards PASCAL System

Continued Access Study

EXPERIMENTAL

Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Device: Edwards PASCAL System

Interventions

Edwards PASCAL System DEVICE

Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy

Also known as: Transcatheter tricuspid valve repair (TTVr)

Edwards PASCAL System & OMT

Optimal Medical Therapy DRUG

Optimal Medical Therapy alone in patients with tricuspid regurgitation

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:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (79)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

ACTIVE NOT RECRUITING

Tucson Medical Center Healthcare

Tucson, Arizona, 85712, United States

ACTIVE NOT RECRUITING

University of California, Irvine

Irvine, California, 92868, United States

RECRUITING

SCPMG - Kaiser San Diego

La Jolla, California, 92037, United States

ACTIVE NOT RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

Kaiser Permanente San Francisco

San Francisco, California, 94118, United States

ACTIVE NOT RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

ACTIVE NOT RECRUITING

St. Joseph Hospital

Denver, Colorado, 80218, United States

RECRUITING

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

ACTIVE NOT RECRUITING

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, 32605, United States

RECRUITING

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

RECRUITING

NCH Healthcare System

Naples, Florida, 34102, United States

RECRUITING

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

RECRUITING

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

ACTIVE NOT RECRUITING

Emory University Hospital Midtown / Emory University - St. Joseph's Hospital

Atlanta, Georgia, 30308, United States

RECRUITING

Piedmont Healthcare, Inc.

Atlanta, Georgia, 30309, United States

ACTIVE NOT RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Ascension St. Vincent Heart Center Cardiovascular Research Institute

Indianapolis, Indiana, 46290, United States

RECRUITING

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

ACTIVE NOT RECRUITING

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

ACTIVE NOT RECRUITING

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

William Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

RECRUITING

St. Mary's of Ascension Research

Saginaw, Michigan, 48601, United States

ACTIVE NOT RECRUITING

Fairview Health Services

Maplewood, Minnesota, 55109, United States

ACTIVE NOT RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Providence St. Patrick Hospital

Missoula, Montana, 59802, United States

ACTIVE NOT RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Cooper Health Systems

Camden, New Jersey, 09103, United States

RECRUITING

Morristown Medical Center

Morristown, New Jersey, 07962, United States

RECRUITING

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

RECRUITING

State University of New York at Buffalo

Buffalo, New York, 14203, United States

RECRUITING

Columbia University Irving Medical Center/NYPH

New York, New York, 10032, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset

New York, New York, 10075, United States

RECRUITING

Rochester General Hospital

Rochester, New York, 14621, United States

ACTIVE NOT RECRUITING

St. Francis Hospital

Roslyn, New York, 11576, United States

RECRUITING

Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital

The Bronx, New York, 10467, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27517, United States

RECRUITING

Sanford Medical Center Fargo

Fargo, North Dakota, 58104, United States

ACTIVE NOT RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

TriHealth-Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

ACTIVE NOT RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

ACTIVE NOT RECRUITING

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Oklahoma Heart Institute at Hillcrest Medical Center

Tulsa, Oklahoma, 74104, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Penn State Hershey

Hershey, Pennsylvania, 17033, United States

RECRUITING

Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Pinnacle Health Cardiovascular Institute/UPMC Pinnacle

Wormleysburg, Pennsylvania, 17043, United States

RECRUITING

Lankenau Heart Institute

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29245, United States

ACTIVE NOT RECRUITING

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

ACTIVE NOT RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

ACTIVE NOT RECRUITING

HCA Houston Healthcare Medical Center

Houston, Texas, 77004, United States

RECRUITING

Baylor College of Medicine St. Luke's Medical Center

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

UTHealth/Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

Baylor Scott & White - The Heart Hospital - Plano

Plano, Texas, 75093, United States

RECRUITING

Intermountain Medical Center

Murray, Utah, 84107, United States

ACTIVE NOT RECRUITING

St. George Regional Hospital

St. George, Utah, 84790, United States

RECRUITING

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

ACTIVE NOT RECRUITING

Carilion Medical Center

Roanoke, Virginia, 24014, United States

RECRUITING

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98122, United States

ACTIVE NOT RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

ACTIVE NOT RECRUITING

Hamilton Health Services

Hamilton, Ontario, L8L 2X2, Canada

ACTIVE NOT RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4Q7, Canada

ACTIVE NOT RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

ACTIVE NOT RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

ACTIVE NOT RECRUITING

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, G1V 4G5, Canada

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Martin B. Leon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Michael J. Mack, MD

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

• Charles Davidson, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Allen Anderson, MD

  The University of Texas Health Science Center at San Antonio

  STUDY CHAIR

• Gorav Ailawadi, MD

  University of Michigan

  STUDY CHAIR

Central Study Contacts

Edwards TMTT Clinical Affairs

CONTACT

(949) 250-2500; TMTT_Clinical@edwards.com

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: September 18, 2019
• First Posted: September 20, 2019
• Study Start: December 11, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (73); CA (6)