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

Not Applicable

Active, not recruiting

• Conditions: Mitral Valve Insufficiency
• Interventions: Device: Twelve TMVR Implant; Device: Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System

• Registration Number: NCT02322840
• Lead Sponsor: Medtronic Cardiovascular

Brief Summary

PILOT:

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

EFS:

The study is an EFS trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Severe, Symptomatic Mitral Regurgitation

Detailed Description

PILOT:

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, who are deemed ineligible for standard 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 Timeline

• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-23
• Study Start: 2015-04
• Primary Completion: 2022-09-01
• Disposition First Submitted: 2023-08-28
• Disposition First Posted: 2023-09-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

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 (PILOT only)
• 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 Twelve TMVR/Intrepid

Key

Exclusion Criteria

• Left ventricular ejection fraction (LVEF) < 20 (PILOT) or <25% (EFS)
• Evidence of intracardiac mass, thrombus, or vegetation
• Prior valve surgery or need for other valve surgery
• Prior stroke within 4 weeks (PILOT) or 90 days (EFS)
• Prior myocardial infarction within 6 months (PILOT) or 90 days (EFS)
• 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

Arm && Interventions

Group	Intervention	Description
Transcatheter Mitral Valve Replacement (TMVR) Implant	Twelve TMVR Implant	Twelve TMVR Implant
Transcatheter Mitral Valve Replacement (TMVR) Implant	Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System	Twelve TMVR Implant

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
Procedural Success (Number of patients with successful TMVR placement)	Through 5 years	Number of patients with successful TMVR placement
Reduction of MR (Number of patients with a reduction of MR Grade)	Through 5 years	Number of patients with a reduction of MR Grade

Trial Locations

Locations (17)

Methodist Hospital; 🇺🇸 Houston, Texas, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Spectrum Health Hospitals; 🇺🇸 Grand Rapids, Michigan, United States

Mt. Sinai Medical Center; 🇺🇸 New York, New York, United States

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States

Columbia; 🇺🇸 New York, New York, United States

UPMC Pinnacle Harrisburg; 🇺🇸 Wormleysburg, Pennsylvania, United States

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States

Aurora St. Luke's; 🇺🇸 Milwaukee, Wisconsin, United States

Centre Hospitalier Universitaire; 🇫🇷 Lille, France

St. Thomas' Hospital; 🇬🇧 London, United Kingdom

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

Royal Prince Alfred Hospital; 🇦🇺 Sydney, Australia

Abrazo Arizon Heart Hospital; 🇺🇸 Phoenix, Arizona, United States

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Oregon Health Sciences University Hospital; 🇺🇸 Portland, Oregon, United States