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

Covidien

Status

Active, not recruiting

Conditions

Mitral Valve Insufficiency

Treatments

Device: Twelve TMVR Implant

Device: Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02322840

CIP-1403 & MDT19042TMV002

Details and patient eligibility

About

PILOT:

The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients.

EFS:

The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation

Full description

PILOT:

The study is a prospective, multi-center, non-randomized study to evaluate the safety and performance of The Intrepid™ TMVR System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.

EFS:

The study is a multi-center, prospective, non-randomized, trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Moderate-Severe or Severe, Symptomatic Mitral Regurgitation

Enrollment

128 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Severe mitral regurgitation (PILOT)
moderate-severe or severe mitral regurgitation (EFS)
Symptomatic mitral regurgitation (NYHA Class II-IV)
Deemed to be at high risk for conventional mitral valve surgery by the local heart team (including, at minimum, a cardiac surgeon, interventional cardiologist, and an echocardiologist) (PILOT and EFS)
Subjects anatomically suitable for the Intrepid TMVR delivery system, including transfemoral and transseptal access (EFS only)
Native mitral valve geometry and size compatible with the Intrepid™ TMVR (PILOT)

Key Exclusion Criteria:

Left ventricular ejection fraction (LVEF) < 20 (PILOT) or <30% (EFS)
Evidence of intracardiac mass, thrombus, or vegetation
Prior valve surgery or need for other valve surgery
Prior stroke within 30 days (PILOT) or 90 days (EFS)
Gastrointestinal bleeding within 6 months (PILOT)
Prior myocardial infarction 90 days (EFS)
Need for coronary revascularization
History of, or active, endocarditis if antibiotics are required (EFS)
Renal insufficiency; Serum Creatinine > 2.5 mg/dL (PILOT) or Creatinine Clearance <30 cc/min (EFS)