Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System

Not Applicable

Active, not recruiting

• Conditions: Mitral Valve Insufficiency

• Registration Number: NCT02322840
• Lead Sponsor: Medtronic Cardiovascular

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-31
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Key Inclusion Criteria:<br><br> - Severe mitral regurgitation (MR Grade 3-4+)<br><br> - Symptomatic mitral regurgitation (NYHA Class II-IV)<br><br> - Trans-apical access deemed feasible by the treating physician (PILOT only)<br><br> - Subjects anatomically suitable for the Intrepid TMVR delivery system including<br> transfemoral and transseptal access (EFS only)<br><br> - Native mitral valve geometry and size compatible with the Twelve TMVR/Intrepid<br><br>Key Exclusion Criteria:<br><br> - Left ventricular ejection fraction (LVEF) < 20 (PILOT) or <25% (EFS)<br><br> - Evidence of intracardiac mass, thrombus, or vegetation<br><br> - Prior valve surgery or need for other valve surgery<br><br> - Prior stroke within 4 weeks (PILOT) or 90 days (EFS)<br><br> - Prior myocardial infarction within 6 months (PILOT) or 90 days (EFS)<br><br> - Need for coronary revascularization<br><br> - History of, or active, endocarditis<br><br> - Renal insufficiency (Creatinine > 2.5 mg/dL)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events

Secondary Outcome Measures

Name	Time	Method
Procedural Success (Number of patients with successful TMVR placement);Reduction of MR (Number of patients with a reduction of MR Grade)