Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Purpose

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Condition

  • Mitral Valve Regurgitation

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Moderate to severe or severe symptomatic mitral regurgitation - Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention

Exclusion Criteria

  • prior transcatheter mitral valve procedure with device currently implanted - anatomic contraindications - prohibitive mitral annular calcification - left ventricular ejection fraction <25% - need for emergent or urgent surgery - hemodynamic instability

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Primary Cohort- TMVR 		Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
  • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
    mitral valve replacement
  • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
    Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement
Experimental
Mitral Annular Calcification -TMVR 		Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
  • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
    mitral valve replacement
  • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
    Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement

Recruiting Locations

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Contact:
Julie Anderson
617-525-7044
janderson58@bwh.harvard.edu

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Lina Fu
617-643-1371
lfu2@partners.org

More Details

Status
Recruiting
Sponsor
Medtronic Cardiovascular

Study Contact

Megan Wilder Fredrickson
612-469-1749
rs.tmvrpivotaltrial@medtronic.com