Recruiting

Edwards PASCALEdwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Sponsor:

Edwards Lifesciences

Code:

NCT04097145

Conditions

Tricuspid Regurgitation

Tricuspid Valve Insufficiency

Tricuspid Valve Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Edwards PASCAL System

Optimal Medical Therapy

Edwards PASCAL System

Study Details

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 Insufficiency

Tricuspid Valve Disease

Study ID

NCT04097145

Start date

Dec 11, 2019

Status verified date

Jun, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Edwards PASCAL System & OMT

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

active comparator: Optimal Medical Therapy (OMT)

Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation

experimental: 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

experimental: Continued Access Study

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

Interventions

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

Primary outcome measure

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) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Edwards TMTT Clinical Affairs

(949) 250-2500 TMTT_Clinical@edwards.com

Locations

University of California, Irvine

Recruiting

Irvine, California, United States, 92868

Principal Investigator:

Antonio Frangieh, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Principal Investigator:

Sammy Elmariah, MD

St. Joseph Hospital

Recruiting

Denver, Colorado, United States, 80218

Principal Investigator:

Jake Chanin, MD

The Cardiac and Vascular Institute Research Foundation

Recruiting

Gainesville, Florida, United States, 32605

Principal Investigator:

Charles Klodell, MD

Mount Sinai Medical Center

Recruiting

Miami Beach, Florida, United States, 33140

Principal Investigator:

Nirat Beohar, MD

NCH Healthcare System

Recruiting

Naples, Florida, United States, 34102

Principal Investigator:

Robert Cubeddu, MD

Sarasota Memorial Health Care System

Recruiting

Sarasota, Florida, United States, 34239

Principal Investigator:

Ricardo A. Yaryura, MD

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

Recruiting

Atlanta, Georgia, United States, 30308

Principal Investigator:

Adam Greenbaum, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Charles Davidson, MD

Ascension St. Vincent Heart Center Cardiovascular Research Institute

Recruiting

Indianapolis, Indiana, United States, 46290

Principal Investigator:

James Hermiller, MD

Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator:

Rani Hasan, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Nilay Patel, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Stanley Chetcuti, MD

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Principal Investigator:

Brian O' Neill, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Mackram Eleid, MD

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Principal Investigator:

Adnan Chhatriwalla, MD

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Principal Investigator:

Michael Young, MD

Cooper Health Systems

Recruiting

Camden, New Jersey, United States, 09103

Principal Investigator:

Sajjad Sabir, MD

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07962

Principal Investigator:

Gennaro Giustino, MD

Rutgers Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator:

Mark Russo, MD

State University of New York at Buffalo

Recruiting

Buffalo, New York, United States, 14203

Principal Investigator:

Vijay Iyer, MD, PhD

Columbia University Irving Medical Center/NYPH

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Michael Brener, MD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Principal Investigator:

Shmuel Chen, MD

Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset

Recruiting

New York, New York, United States, 10075

Principal Investigator:

Mei Chau, MD

St. Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Principal Investigator:

George A. Petrossian, MD

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

Recruiting

The Bronx, New York, United States, 10467

Principal Investigator:

Mohamed A. Latib, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27517

Principal Investigator:

John Vavalle, MD

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Santiago Garcia, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Konstantinos Boudoulas, MD

Oklahoma Cardiovascular Research Group

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Principal Investigator:

Mohammad Ghani, MD

Oklahoma Heart Institute at Hillcrest Medical Center

Recruiting

Tulsa, Oklahoma, United States, 74104

Principal Investigator:

Kamran Muhammad, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Firas Zahr, MD

Penn State Hershey

Recruiting

Hershey, Pennsylvania, United States, 17033

Principal Investigator:

Mark Kozak, MD

Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Gene Chang, MD

Pinnacle Health Cardiovascular Institute/UPMC Pinnacle

Recruiting

Wormleysburg, Pennsylvania, United States, 17043

Principal Investigator:

Mubashir Mumtaz, MD

Lankenau Heart Institute

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Principal Investigator:

William Gray, MD

HCA Houston Healthcare Medical Center

Recruiting

Houston, Texas, United States, 77004

Principal Investigator:

Pranav Loyalka, MD

Baylor College of Medicine St. Luke's Medical Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Guilherme Silva, MD

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Abhijeet Dhoble, MD

UTHealth/Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Biswajit Kar, MD

Baylor Scott & White - The Heart Hospital - Plano

Recruiting

Plano, Texas, United States, 75093

Principal Investigator:

Molly Szerlip, MD

St. George Regional Hospital

Recruiting

St. George, Utah, United States, 84790

Principal Investigator:

Blake Gardner, MD

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator:

John Saxon, MD

Carilion Medical Center

Recruiting

Roanoke, Virginia, United States, 24014

Principal Investigator:

Jason Foerst, MD

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Principal Investigator:

Ming Zhang, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

Jeremiah Depta, MD

More Information

Sponsor

Edwards Lifesciences

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Edwards Lifesciences on 2026-07-06.