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Edwards PASCAL System for Tricuspid Regurgitation

This study is testing the Edwards PASCAL Transcatheter Repair System for people with severe tricuspid regurgitation (a heart condition where the tricuspid valve doesn't close properly, causing blood to leak backward). You might be eligible if you are 18 or older, have severe tricuspid regurgitation despite medical treatment, and experience symptoms like shortness of breath or have been hospitalized for heart failure. The study aims to see if the Edwards PASCAL System, used with your current medical therapy, is safe and effective compared to just continuing your medical therapy alone. Success will be measured by how well you feel, your quality of life, and if you need further heart procedures or hospitalizations. The study plans to enroll up to 1270 participants, but its current status is unclear.

Study design
This is a randomized controlled trial comparing the Edwards PASCAL System plus optimal medical therapy to optimal medical therapy alone. It plans to enroll up to 1270 participants.
What's involved
You would have follow-up visits at discharge, 30 days, 3 months, 6 months, and annually through 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04097145

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Recruiting
NAAges 18+InterventionalTreatment
Edwards Lifesciences
~1,270 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Edwards PASCAL SystemOptimal Medical Therapy

At a glance

Recruiting sites
45 of 79 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over 6 months

Conditions

Tricuspid Regurgitation
Tricuspid Valve Insufficiency
Tricuspid Valve Disease

Explore related trials

Tricuspid Valve Insufficiency

NCT04097145

Where you'd take part

This study runs at 79 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ascension St. Vincent Heart Center Cardiovascular Research Institute

    Indianapolis, Indianano site contact published

    Recruiting

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

    Houston, Texasno site contact published

    Recruiting

  • Baylor Scott & White - The Heart Hospital - Plano

    Plano, Texasno site contact published

    Recruiting

  • Carilion Medical Center

    Roanoke, Virginiano site contact published

    Recruiting

  • Columbia University Irving Medical Center/NYPH

    New York, New Yorkno site contact published

    Recruiting

  • Cooper Health Systems

    Camden, New Jerseyno site contact published

    Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshireno site contact published

    Recruiting

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

    Atlanta, Georgiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Martin B. Leon, MD · PRINCIPAL_INVESTIGATOR · Columbia University
  • Michael J. Mack, MD · PRINCIPAL_INVESTIGATOR · Baylor Scott and White Health
  • Charles Davidson, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
  • Allen Anderson, MD · STUDY_CHAIR · The University of Texas Health Science Center at San Antonio
  • Gorav Ailawadi, MD · STUDY_CHAIR · University of Michigan

Who to contact

Edwards TMTT Clinical Affairs
[email protected]
(949) 250-2500
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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:
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:
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

What this trial measures

  • 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)6 months

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