Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

Covidien

Status: Terminated

Conditions: Mitral Valve Insufficiency

Treatments: Device: TMVR Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02428010

CIP-1402

Details and patient eligibility

About

Study to evaluate the safety and performance of the Twelve TMVR System

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Treatment

Experimental group

Description:

TMVR Implant

Treatment:

Device: TMVR Implant