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NOT YET RECRUITING
NCT04396379
NA

Epicardial Mitral Touch System for Mitral Insufficiency

Sponsor: Mitre Medical Corp.

View on ClinicalTrials.gov

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

DEVICE

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