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

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2028-12-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Mitral Valve Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcatheter Mitral Valve Replacement (TMVR) Implant

Twelve TMVR Implant

Group Type EXPERIMENTAL

Twelve TMVR Implant

Intervention Type DEVICE

Implantation of the Twelve TMVR System - Apical

Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System

Intervention Type DEVICE

Implantation of the Medtronic Intrepid™ Transcatheter Mitral Valve- Transfemoral

Interventions

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Twelve TMVR Implant

Implantation of the Twelve TMVR System - Apical

Intervention Type DEVICE

Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System

Implantation of the Medtronic Intrepid™ Transcatheter Mitral Valve- Transfemoral

Intervention Type DEVICE

Other Intervention Names

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Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System

Eligibility Criteria

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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)

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lynnett Stahl

Role: STUDY_DIRECTOR

Medtronic

Locations

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Abrazo Arizona Heart Hospital - EFS

Phoenix, Arizona, United States

Site Status

Cedars-Sinai Medical Center - PILOT

Los Angeles, California, United States

Site Status

Piedmont Atlanta Hospital - PILOT

Atlanta, Georgia, United States

Site Status

Northwestern Memorial Hospital - PILOT

Chicago, Illinois, United States

Site Status

University of Michigan Health System - University Hospital - PILOT

Ann Arbor, Michigan, United States

Site Status

Corewell Health - EFS

Grand Rapids, Michigan, United States

Site Status

Abbott Northwestern Hospital - EFS

Minneapolis, Minnesota, United States

Site Status

Abbott Northwestern Hospital - PILOT

Minneapolis, Minnesota, United States

Site Status