Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study (PRELUDE)
Status: Unknown
Location: See all (13) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Has severe mitral regurgitation
• New York Heart Association (NYHA) Class II, III, IVa or heart failure
• High risk for cardiovascular surgery
Locations
United States
California
Cedars Sinai Medical Center
Los Angeles
Washington, D.c.
MedStar Washington Hospital Center
Washington
Florida
Delray Medical Center
Delray Beach
Minnesota
Abbott Northwestern Hospital
Minneapolis
Mayo Clinic
Rochester
New Jersey
Morristown Medical Center
Morristown
New York
New York University Langone Medical Center
New York
Ohio
Cleveland Clinic Foundation
Cleveland
OhioHealth
Columbus
Tennessee
Saint Thomas Heart
Nashville
Virginia
University of Virginia Health System
Charlottesville
Washington
Swedish Health Services
Seattle
University of Washington
Seattle
Time Frame
Start Date: 2016-06
Completion Date: 2023-12
Participants
Target number of participants: 20
Treatments
Experimental: Treatment Arm
All eligible patients will be in the treatment arm for the 'Caisson TMVR System' (transcatheter mitral valve replacement) procedure. No control or comparator in this study.
Authors
Evelio Rodriguez, Brijeshwar Maini, Steven Yakubov, Samir Kapadia, Robert Kipperman, Charanjit Rihal, Mario Goessl, Saibal Kar, Lowell Satler
Related Therapeutic Areas
Sponsors
Leads: Caisson Interventional LLC