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Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Edwards Lifesciences · NCT04097145

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
1270
US sites recruiting
45
Study start
December 11, 2019
Record last updated
September 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Edwards PASCAL System; Optimal Medical Therapy; Edwards PASCAL System; Edwards PASCAL System

Conditions: Tricuspid Regurgitation; Tricuspid Valve Insufficiency; Tricuspid Valve Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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:
  • 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
  • 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

Recruiting US locations

  • University of California, Irvine

    Irvine, CA 92868

    Site contact: Antonio Frangieh, MD

  • University of California, San Francisco

    San Francisco, CA 94143

    Site contact: Sammy Elmariah, MD

  • St. Joseph Hospital

    Denver, CO 80218

    Site contact: Jake Chanin, MD

  • The Cardiac and Vascular Institute Research Foundation

    Gainesville, FL 32605

    Site contact: Charles Klodell, MD

  • Mount Sinai Medical Center

    Miami Beach, FL 33140

    Site contact: Nirat Beohar, MD

  • NCH Healthcare System

    Naples, FL 34102

    Site contact: Robert Cubeddu, MD

  • Sarasota Memorial Health Care System

    Sarasota, FL 34239

    Site contact: Ricardo A. Yaryura, MD

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

    Atlanta, GA 30308

    Site contact: Adam Greenbaum, MD

  • Northwestern University

    Chicago, IL 60611

    Site contact: Charles Davidson, MD

  • Ascension St. Vincent Heart Center Cardiovascular Research Institute

    Indianapolis, IN 46290

    Site contact: James Hermiller, MD

  • Johns Hopkins

    Baltimore, MD 21287

    Site contact: Rani Hasan, MD

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Nilay Patel, MD

  • University of Michigan

    Ann Arbor, MI 48109

    Site contact: Stanley Chetcuti, MD

  • Henry Ford Hospital

    Detroit, MI 48202

    Site contact: Brian O' Neill, MD

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Mackram Eleid, MD

  • Saint Luke's Hospital of Kansas City

    Kansas City, MO 64111

    Site contact: Adnan Chhatriwalla, MD

  • Dartmouth-Hitchcock Medical Center

    Lebanon, NH 03756

    Site contact: Michael Young, MD

  • Cooper Health Systems

    Camden, NJ 09103

    Site contact: Sajjad Sabir, MD

  • Morristown Medical Center

    Morristown, NJ 07962

    Site contact: Gennaro Giustino, MD

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, NJ 08901

    Site contact: Mark Russo, MD

  • State University of New York at Buffalo

    Buffalo, NY 14203

    Site contact: Vijay Iyer, MD, PhD

  • Columbia University Irving Medical Center/NYPH

    New York, NY 10032

    Site contact: Michael Brener, MD

  • Weill Cornell Medicine

    New York, NY 10065

    Site contact: Shmuel Chen, MD

  • Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset

    New York, NY 10075

    Site contact: Mei Chau, MD

  • St. Francis Hospital

    Roslyn, NY 11576

    Site contact: George A. Petrossian, MD

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

    The Bronx, NY 10467

    Site contact: Mohamed A. Latib, MD

  • University of North Carolina

    Chapel Hill, NC 27517

    Site contact: John Vavalle, MD

  • The Christ Hospital

    Cincinnati, OH 45219

    Site contact: Santiago Garcia, MD

  • The Ohio State University

    Columbus, OH 43210

    Site contact: Konstantinos Boudoulas, MD

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, OK 73120

    Site contact: Mohammad Ghani, MD

  • Oklahoma Heart Institute at Hillcrest Medical Center

    Tulsa, OK 74104

    Site contact: Kamran Muhammad, MD

  • Oregon Health & Science University

    Portland, OR 97239

    Site contact: Firas Zahr, MD

  • Penn State Hershey

    Hershey, PA 17033

    Site contact: Mark Kozak, MD

  • Pinnacle Health Cardiovascular Institute/UPMC Pinnacle

    Wormleysburg, PA 17043

    Site contact: Mubashir Mumtaz, MD

  • Lankenau Heart Institute

    Wynnewood, PA 19096

    Site contact: William Gray, MD

  • HCA Houston Healthcare Medical Center

    Houston, TX 77004

    Site contact: Pranav Loyalka, MD

  • Baylor College of Medicine St. Luke's Medical Center

    Houston, TX 77030

    Site contact: Guilherme Silva, MD

  • The University of Texas Health Science Center at Houston

    Houston, TX 77030

    Site contact: Abhijeet Dhoble, MD

  • UTHealth/Memorial Hermann Hospital

    Houston, TX 77030

    Site contact: Biswajit Kar, MD

  • Baylor Scott & White - The Heart Hospital - Plano

    Plano, TX 75093

    Site contact: Molly Szerlip, MD

  • St. George Regional Hospital

    St. George, UT 84790

    Site contact: Blake Gardner, MD

  • University of Virginia Health System

    Charlottesville, VA 22908

    Site contact: John Saxon, MD

  • Carilion Medical Center

    Roanoke, VA 24014

    Site contact: Jason Foerst, MD

  • Virginia Mason Medical Center

    Seattle, WA 98101

    Site contact: Ming Zhang, MD

  • Medical College of Wisconsin

    Milwaukee, WI 53226

    Site contact: Jeremiah Depta, MD

Study contacts (from the official record)

  • Edwards TMTT Clinical Affairs · (949) 250-2500 · CLASPIITRTrialMgmt@edwards.com
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical… (NCT04097145) | Bored Studies