Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study
Not Applicable
Terminated
- Conditions
- Mitral Valve Insufficiency
- Interventions
- Device: TMVR Implant
- Registration Number
- NCT02428010
- Lead Sponsor
- Medtronic Cardiovascular
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
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
Key
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment TMVR Implant TMVR Implant
- Primary Outcome Measures
Name Time Method Adverse Events 30 days Number of patients with adverse events associated with the delivery and/or implantation of the device
- Secondary Outcome Measures
Name Time Method Reduction of MR Through 5 years Number of patients with a reduction of MR Grade
Procedural Success Through 5 years Number of patients with successful TMVR implant
Trial Locations
- Locations (1)
John Paul II Hospital
🇵🇱Krakow, Poland