Study Information
Study Details
View study details on clinicaltrials.gov.
Locations
Clinical Trial FAQs
Information for patients and study volunteers, including frequently asked questions.
Description
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF)
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT).
Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
Principal Investigator
Pei-Hsiu Huang, M.D., Dr. Christian Spies, MD
Co-Investigator(s)
Zijian Xu, M.D., Ph.D., FACC, David K. Roberts, III, M.D., FACC, Michael T. Ingram, Sr., M.D., Gurpreet Sodhi, MD