RecruitingNot Applicable

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

United States1,270 participantsStarted 2019-12-11

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 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
✕. 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

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)

Timeframe: 6 months

Trial details

NCT IDNCT04097145

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Edwards TMTT Clinical Affairs

(949) 250-2500 TMTT_Clinical@edwards.com

View on ClinicalTrials.gov More Tricuspid Regurgitation trials