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

Mitral Valve Regurgitation

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

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation Criteria

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 Location

St. Paul's Hospital
St. Paul's Hospital
Vancouver, British Columbia
Canada

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Glen Royal Victoria Hospital
Glen Royal Victoria Hospital
Montreal, Quebec
Canada

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Royal Columbian Hospital
Royal Columbian Hospital
New Westminster, British Columbia
Canada

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Montreal Heart Insitute
Montreal Heart Insitute
Montreal, Quebec
Canada

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Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

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St. Michael's Hospital
St. Michael's Hospital
Toronto, Ontario
Canada

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Study Sponsored By
Medtronic Cardiovascular
Participants Required
More Information
Study ID: NCT03242642