NL-OMON49193
Completed
Not Applicable
Tiara* Transcatheter Mitral Valve Replacement Study - TIARA-II 047-CPT-003
eovasc Medical Inc.0 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- severe mitral regurgitation
- Sponsor
- eovasc Medical Inc.
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age 18 years or older.
- •2\. NYHA Class II to ambulatory Class IV.
- •3\. Severe mitral regurgitation (reference Section 20\)
- •4\. High surgical risk for open mitral valve surgery as determined by the
- •examining cardiac surgeon and the local institutional Heart Team (consisting of
- •an interventional cardiologist and cardiac surgeon, at a minimum) based on an
- •STS mitral valve replacement PROM \>\=8% and/or the Heart Team assessing the risk
- •of operative mortality \>\=8% (modified from 2014 AHA/ACC Valvular Heart Disease
- •Guidelines definition of high risk).
- •5\. Subject meets the initial anatomical eligibility criteria for annulus size
Exclusion Criteria
- •1\. Deemed too frail by objective frailty assessments or with severe
- •comorbidities such that the subject is unlikely to benefit from the procedure
- •as determined by the local institutional Heart Team.
- •2\. Previous cardiac procedures:
- •a. PCI within 30 days of enrollment
- •b. Drug Eluting Stent implantation within 30 days of enrollment
- •c. Bare Metal Stent implantation within 30 days of enrollment
- •d. Coronary artery bypass graft (CABG) within 30 days of enrollment
- •e. Any surgical or transcatheter mitral valve replacement that would interfere
- •with the placement of the TiaraMitral Valve
Outcomes
Primary Outcomes
Not specified
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