RecruitingTricuspid RegurgitationTricuspid Valve InsufficiencyTricuspid Valve Disease

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Eligible age

18+ yrs

Accepts

All genders

Locations

31 states

Healthy volunteers

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About this study

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

Sponsor: Edwards Lifesciences

You may qualify if…

✓ 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

You may not qualify if…

✕ 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