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

N/AActive Not RecruitingNCT02322840

Medtronic Cardiovascular128 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

128

Conditions

Mitral Valve Insufficiency

Interventions

Twelve TMVR ImplantDEVICE

Implantation of the Twelve TMVR System - Apical

Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement SystemDEVICE

Implantation of the Medtronic Intrepid™ Transcatheter Mitral Valve- Transfemoral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (32)

Outcomes

Primary Outcomes

Percent of Subjects With Adverse Events

PILOT: Site Reported Serious Adverse Events Implant or Delivery Related Through 30-Days EFS: Implant, Delivery or device related serious adverse events through 30 days post procedure

Time frame: 30 days

Secondary Outcomes

Number of Subjects With Procedural Success

PILOT: Successful access, delivery of implant, and retrieval of the delivery system EFS: Successful access, delivery of implant, and retrieval of the delivery system

Time frame: Procedure

Change in Mitral Regurgitation (MR) From Baseline Through 30 Days

PILOT: Change in MR Grade from baseline measured by echo through 30 days post-procedure. Measured by Echo 30 days post procedure.

Time frame: 30 days

Change in Mitral Regurgitation (MR) From Baseline Through 30 Days

EFS: Change in MR Grade from Baseline measured by echo through 30 days post-procedure. Measured by Echo 30 days post procedure.

Time frame: Through 30 Days

Change in New York Heart Association (NYHA) From Baseline Through 30 Days

PILOT: Change in NYHA Class from Baseline through 30 days post-procedure.

Time frame: Through 30 days

Change in New York Heart Association (NYHA) From Baseline Through 30 Days

EFS: Change in NYHA Class from Baseline through 30 days post procedure

Time frame: Through 30 Days

Number of Subjects Without Mitral Valve Stenosis

PILOT: No significant mitral Valve (MV) Stenosis measured by echo through 30 days post-procedure EFS: No Significant Mitral Valve (MV) Stenosis measured by echo through 30 days post-procedure

Data from ClinicalTrials.gov

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Abrazo Arizona Heart Hospital - EFS

Phoenix, Arizona, United States

Cedars-Sinai Medical Center - PILOT

Los Angeles, California, United States

Piedmont Atlanta Hospital - PILOT

Atlanta, Georgia, United States

Northwestern Memorial Hospital - PILOT

Chicago, Illinois, United States

University of Michigan Health System - University Hospital - PILOT

Ann Arbor, Michigan, United States

Corewell Health - EFS

Grand Rapids, Michigan, United States

Abbott Northwestern Hospital - EFS

Minneapolis, Minnesota, United States

Abbott Northwestern Hospital - PILOT

Minneapolis, Minnesota, United States

Barnes Jewish Hospital - PILOT

St Louis, Missouri, United States

NYU Langone Medical Center - PILOT

New York, New York, United States

...and 22 more locations