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Epicardial Mitral Touch System for Mitral Insufficiency
Sponsor: Mitre Medical Corp.
Summary
To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.
Official title: ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2023-09-10
Completion Date
2027-12-31
Last Updated
2023-01-04
Healthy Volunteers
No
Interventions
Implant an epicardial device to reshape the mitral valve annulus
The implant is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR.
Locations (1)
Baylor Scott and White
Plano, Texas, United States