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

ID#: NCT03242642

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: October 23, 2017

End Date: October 01, 2025

Contact Information:
Megan Wilder Fredrickson
612-469-1749
Summary: Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Eligibility:

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
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