Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

Not Applicable

Terminated

• Conditions: Mitral Valve Insufficiency

• 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-28
• Status Verified: 2021-04
• Primary Completion: 2021-04
• Study Completion: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-04

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

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