NCT02428010TerminatedNot Applicable
Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Medtronic Cardiovascular1 site in 1 country3 target enrollmentStarted: September 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Adverse Events
Study Overview
Brief Summary
Study to evaluate the safety and performance of the Twelve TMVR System
Detailed Description
The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high risk patients with severe, symptomatic mitral regurgitation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Severe mitral regurgitation (MR Grade 3-4+)
- •Symptomatic mitral regurgitation (NYHA Class II-IV)
- •Trans-apical access deemed feasible by the treating physician
- •Native mitral valve geometry and size compatible with the Twelve TMVR
Exclusion Criteria
- •Left ventricular ejection fraction (LVEF) < 20
- •Evidence of intracardiac mass, thrombus, or vegetation
- •Prior valve surgery or need for other valve surgery
- •Prior stroke within 4 weeks
- •Need for coronary revascularization
- •History of, or active, endocarditis
- •Renal insufficiency (Creatinine > 2.5 mg/dL)
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 30 days
Number of patients with adverse events associated with the delivery and/or implantation of the device
Secondary Outcomes
- Reduction of MR(Through 5 years)
- Procedural Success(Through 5 years)
Investigators
Study Sites (1)
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