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

Mitral Valve Insufficiency Clinical Trial

Official title:

An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02322840
• Other study ID #: MDT19042TMV002
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: December 2028
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (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)

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

Device:
• Twelve TMVR Implant
Implantation of the Twelve TMVR System -Apical
• Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
Implant of Intrepid valve -Transfemoral

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Sydney
Denmark	Rigshospitalet	Copenhagen
France	Centre Hospitalier Universitaire	Lille
United Kingdom	St. Thomas' Hospital	London
United States	Piedmont Hospital	Atlanta	Georgia
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Spectrum Health Hospitals	Grand Rapids	Michigan
United States	Methodist Hospital	Houston	Texas
United States	Aurora St. Luke's	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Columbia	New York	New York
United States	Mt. Sinai Medical Center	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Abrazo Arizon Heart Hospital	Phoenix	Arizona
United States	Oregon Health Sciences University Hospital	Portland	Oregon
United States	UPMC Pinnacle Harrisburg	Wormleysburg	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiovascular	Medtronic

Countries where clinical trial is conducted

United States,  Australia,  Denmark,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of patients with adverse events associated with the delivery and/or implantation of the device	30 days
Secondary	Procedural Success (Number of patients with successful TMVR placement)	Number of patients with successful TMVR placement	Through 5 years
Secondary	Reduction of MR (Number of patients with a reduction of MR Grade)	Number of patients with a reduction of MR Grade	Through 5 years