Status:
ACTIVE_NOT_RECRUITING
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
Lead Sponsor:
Shockwave Medical, Inc.
Conditions:
Mitral Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
This is an international, multicenter, single arm, prospective, Early Feasibility Clinical Study to evaluate the safety and performance of the Neovasc Tiara Mitral Valve System in subjects with sympto...
Eligibility Criteria
Inclusion
- 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
Exclusion
- DMR deemed by the heart team to be operable.
- Prohibitive risk, deemed too frail or listed for cardiac transplant.
- Unsuitable cardiac structure
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02276547
Start Date
December 1 2014
End Date
August 1 2025
Last Update
May 20 2025
Active Locations (10)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Henry Ford Health System
Detroit, Michigan, United States, 48188
4
Washington University
St Louis, Missouri, United States, 63110