NCT03864848

Epicardial Mitral Repair Trial - ENRAPT-MR

ENRAPT-MR Trial: Epicardial Mitral Repair

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mitre Medical Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Mitral Touch System This device is designed to epicardially reshape the mitral valve annulus without the need for cardiopulmonary bypass (CPB) and open heart access (atriotomy), in patients with left ventricular dilation and ischemic or functional MR (mitral regurgitation (MR)).

Detailed description

Mitre Medical has developed an epicardial mitral annuloplasty device that can be implanted concomitant during planned coronary artery bypass surgery to help treat the MR patients. The Mitral Touch is designed to restore the S-L dimension and has the advantage of being placed without stopping the heart and placing the patient on a bypass pump.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	Mitral Touch Implant	The study population for this study will be comprised of patients who are to undergo cardiac surgery with a sternotomy (e.g. CABG) and who present moderate to severe ischemic or functional MR. In order to be considered eligible for the study, each patient must meet the conditions listed in the inclusion and none of the exclusion criteria.

Timeline

• Start date: 2017-12-18
• Primary completion: 2024-12-20
• Completion: 2024-12-20
• First posted: 2019-03-06
• Last updated: 2023-01-18

Locations

1 site across 1 country: Lithuania

Regulatory

• FDA-regulated device study