Purpose

Multi-center, global, prospective, randomized, interventional, pre-market trial with two subject groups: the randomized group will be randomized on 1:1 basis to either the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the study device. Subjects will be seen at pre- and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.

Condition

Eligibility

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

Inclusion Criteria

  • moderate to severe or severe symptomatic mitral regurgitation
  • candidate for bioprosthetic mitral valve replacement, as determined by heart team

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
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Surgical Candidate - 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
Active Comparator
Surgical Candidate - SMVR
Treatment of mitral regurgitation with conventional Surgical Mitral Valve Replacement (SMVR)
  • Device: Surgical Mitral Valve Replacement (SMVR)
    mitral valve replacement
Experimental
Non-Surgical Candidate - 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

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030

More Details

NCT ID
NCT03242642
Status
Recruiting
Sponsor
Medtronic Cardiovascular

Study Contact

Kristin Boulware
763-514-9809
rs.tmvrpivotaltrial@medtronic.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.