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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

MedStar Washington Hospital Center
Washington, District of Columbia 20010

More Details

Status
Recruiting
Sponsor
Medtronic Cardiovascular

Study Contact

Megan Wilder Fredrickson
612-469-1749
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.