Mitral Valve Insufficiency
Conditions
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.
Interventions
DEVICETMVR Implant
Implantation of the Twelve TMVR System
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 30 days | Number of patients with adverse events associated with the delivery and/or implantation of the device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | Through 5 years | Number of patients with successful TMVR implant |
| Reduction of MR | Through 5 years | Number of patients with a reduction of MR Grade |
Countries
Poland
Outcome results
None listed