Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System
Status: Active_not_recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Severe symptomatic mitral regurgitation (Stage D)
• High surgical risk for open mitral valve surgery
• Subject meets the anatomical eligibility criteria for available size(s)
• NYHA Class III or IV heart failure
Locations
United States
California
Cedars Sinai Medical Center
Los Angeles
Illinois
Northwestern University
Chicago
Michigan
Henry Ford Health System
Detroit
Missouri
Washington University
Saint Louis
New York
Columbia University Medical Center
New York
Washington
University of Washington Medical Center
Seattle
Other Locations
Belgium
ZNA Middelheim
Antwerpen
Canada
University of Alberta
Edmonton
London Health Sciences Centre
London
St. Paul's Hospital
Vancouver
Time Frame
Start Date: 2014-12
Completion Date: 2025-02
Participants
Target number of participants: 27
Treatments
Experimental: Treatment
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Authors
Related Therapeutic Areas
Sponsors
Leads: Shockwave Medical, Inc.