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Transcatheter valve repair for severe tricuspid regurgitation

A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation

Not applicable Interventional Edwards Lifesciences · NCT04097145

This study is testing a new valve repair system to see if it helps people with severe tricuspid regurgitation feel better compared to just taking their medications.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1270 (estimated)
Ages18 Years and up
SexAll
SponsorEdwards Lifesciences Industry-sponsored
Locations79 sites (Phoenix, Arizona and 78 other locations)
Trial IDNCT04097145 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients suffering from symptomatic severe tricuspid regurgitation. It is a prospective, multicenter, randomized, controlled trial comparing transcatheter valve repair combined with optimal medical therapy against optimal medical therapy alone. Patients will be monitored through follow-up visits at discharge, 30 days, 3 months, 6 months, and annually for up to five years to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic severe tricuspid regurgitation who are at intermediate or greater risk for mortality from traditional surgery.

Not a fit: Patients with tricuspid valve anatomy that cannot be evaluated or those requiring advanced interventions for heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and outcomes for patients with severe tricuspid regurgitation who are at high surgical risk.

How similar studies have performed: Other studies have shown promise with transcatheter approaches for valve repair, indicating potential for success with this novel intervention.

Eligibility criteria

Show full inclusion / exclusion 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:

  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

Where this trial is running

Phoenix, Arizona and 78 other locations

+29 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Tricuspid RegurgitationTricuspid Valve InsufficiencyTricuspid Valve Disease
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.