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

Primary Purpose

Mitral Valve Insufficiency

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Twelve TMVR Implant
Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Abrazo Arizon Heart Hospital
  • Piedmont Hospital
  • Northwestern University
  • Spectrum Health Hospitals
  • Abbott Northwestern Hospital
  • NYU Langone Medical Center
  • Mt. Sinai Medical Center
  • Columbia
  • Oregon Health Sciences University Hospital
  • UPMC Pinnacle Harrisburg
  • Methodist Hospital
  • University of Virginia Medical Center
  • Aurora St. Luke's
  • Royal Prince Alfred Hospital
  • Rigshospitalet
  • Centre Hospitalier Universitaire
  • St. Thomas' Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcatheter Mitral Valve Replacement (TMVR) Implant

Arm Description

Twelve TMVR Implant

Outcomes

Primary Outcome Measures

Adverse Events
Number of patients with adverse events associated with the delivery and/or implantation of the device

Secondary Outcome Measures

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

Full Information

First Posted
October 31, 2014
Last Updated
October 13, 2023
Sponsor
Medtronic Cardiovascular
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT02322840
Brief Title
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
Official Title
An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2015 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter Mitral Valve Replacement (TMVR) Implant
Arm Type
Experimental
Arm Description
Twelve TMVR Implant
Intervention Type
Device
Intervention Name(s)
Twelve TMVR Implant
Other Intervention Name(s)
Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System
Intervention Description
Implantation of the Twelve TMVR System -Apical
Intervention Type
Device
Intervention Name(s)
Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
Other Intervention Name(s)
Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System
Intervention Description
Implant of Intrepid valve -Transfemoral
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of patients with adverse events associated with the delivery and/or implantation of the device
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Procedural Success (Number of patients with successful TMVR placement)
Description
Number of patients with successful TMVR placement
Time Frame
Through 5 years
Title
Reduction of MR (Number of patients with a reduction of MR Grade)
Description
Number of patients with a reduction of MR Grade
Time Frame
Through 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynnett Stahl
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
Abrazo Arizon Heart Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mt. Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Oregon Health Sciences University Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
UPMC Pinnacle Harrisburg
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Aurora St. Luke's
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Sydney
Country
Australia
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Centre Hospitalier Universitaire
City
Lille
Country
France
Facility Name
St. Thomas' Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34747699
Citation
Zahr F, Song HK, Chadderdon SM, Gada H, Mumtaz M, Byrne T, Kirshner M, Bajwa T, Weiss E, Kodali S, George I, Heiser J, Merhi WM, Thaden JJ, Zhang A, Lim DS, Reardon MJ, Adams DH, Mack MJ, Leon MB. 30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. JACC Cardiovasc Interv. 2022 Jan 10;15(1):80-89. doi: 10.1016/j.jcin.2021.10.018. Epub 2021 Nov 6.
Results Reference
derived
PubMed Identifier
29102689
Citation
Bapat V, Rajagopal V, Meduri C, Farivar RS, Walton A, Duffy SJ, Gooley R, Almeida A, Reardon MJ, Kleiman NS, Spargias K, Pattakos S, Ng MK, Wilson M, Adams DH, Leon M, Mack MJ, Chenoweth S, Sorajja P; Intrepid Global Pilot Study Investigators. Early Experience With New Transcatheter Mitral Valve Replacement. J Am Coll Cardiol. 2018 Jan 2;71(1):12-21. doi: 10.1016/j.jacc.2017.10.061. Epub 2017 Nov 16.
Results Reference
derived

Learn more about this trial

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

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