NCT03039855
Completed
Not Applicable
Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)
ConditionsMitral Valve Regurgitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Regurgitation
- Sponsor
- Shockwave Medical, Inc.
- Enrollment
- 157
- Locations
- 20
- Primary Endpoint
- Reduction of Mitral Regurgitation to optimal or acceptable
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
Detailed Description
The TIARA-II study is an international, multicenter, single-arm, prospective, safety and performance clinical study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Severe mitral regurgitation
- •High surgical risk for open mitral valve surgery
- •Subject meets anatomical eligibility criteria
Exclusion Criteria
- •Deemed too frail by objective frailty assessments
- •Previous cardiac procedures: any mitral valve replacement surgery and cardiac transplant
- •Unsuitable cardiac structure
- •Clinically significant untreated Coronary Artery Disease (CAD)
- •Subjects on chronic dialysis
- •Pregnant or planning pregnancy within next 12 months
- •Documented bleeding or coagulation disorders
- •Active infections requiring antibiotic therapy
- •Subjects with a life expectancy less than 12 months
Outcomes
Primary Outcomes
Reduction of Mitral Regurgitation to optimal or acceptable
Time Frame: 30 days
Freedom from all-cause mortality
Time Frame: 30 days
Freedom from major adverse events
Time Frame: 30 Days
Secondary Outcomes
- Procedural success(30 days)
- Kansas City Cardiomyopathy Questionnaire(30 days, 90 days, 180 days and once annually for five years)
- Freedom from all-cause mortality(90 days, 180 days, one year and annually to five years)
- Hemodynamic performance(30 days, 90 days, 180 days and once annually for five years)
- NYHA Functional Class(30 days, 90 days, 180 days and once annually for five years)
- Patient success(1 year)
- Freedom from major adverse events(90 days, 180 days, one year and annually to five years)
- Technical success(Day 0)
- Device success(Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years)
- 6 Minute Walk Test(30 days, 90 days, 180 days and once annually for five years)
Study Sites (20)
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