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Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study & EFS of the TMVR Transseptal System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02322840
Recruitment Status : Active, not recruiting
First Posted : December 23, 2014
Last Update Posted : May 1, 2023
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiovascular

Study Description
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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


Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Device: Twelve TMVR Implant Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Actual Study Start Date : April 2015
Actual Primary Completion Date : September 1, 2022
Estimated Study Completion Date : July 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: TMVR Implant
Twelve TMVR Implant
 Device: Twelve TMVR Implant
Implantation of the Twelve TMVR System


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 30 days ]
    Number of patients with adverse events associated with the delivery and/or implantation of the device


Secondary Outcome Measures :
  1. Procedural Success (Number of patients with successful TMVR placement) [ Time Frame: Through 5 years ]
    Number of patients with successful TMVR placement

  2. Reduction of MR (Number of patients with a reduction of MR Grade) [ Time Frame: Through 5 years ]
    Number of patients with a reduction of MR Grade


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02322840


Locations
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Sponsors and Collaborators
Medtronic Cardiovascular
Medtronic
Investigators
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Study Director: Sarah Brown Medtronic
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT02322840    
Other Study ID Numbers: MDT19042TMV002
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: May 1, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases