Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEdwards Lifesciences
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Would prevent proper TR reduction due to interaction of the lead with the leaflets
Trial design
Treatments tested in this trial
- Edwards PASCAL System
- Optimal Medical Therapy
- Edwards PASCAL System
- Edwards PASCAL System
Treatment groups
1,270 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov