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Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): 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

Recruiting

The goal of this trial is to evaluate the safety and effectiveness of the PASCAL System with optimal medical therapy (OMT) compared to OMT alone in participants with symptomatic severe tricuspid regurgitation. We are studying this in patients who may not be ideal candidates for tricuspid valve surgery (performed via open-heart surgery) and may be eligible for transcatheter tricuspid valve repair (minimally invasive procedure that repairs the valve).

I'm interested

Male or Female
18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• symptoms of severe tricuspid valve regurgitation in spite of medical treatment
Exclusion Criteria:

• untreated coronary artery disease, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction
• women who are pregnant, breastfeeding, or planning pregnancy within the next 12 months
• other significant medical diagnosis (study team will review)

Heart & Vascular

Heart Valve, TAVR, Transcatheter Valve Repair System, tricuspid valve

Jenny Lam - jenny.lam@fairview.org
Marat Yanavitski
Pivotal
SITE00001026
See this study on ClinicalTrials.gov

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