NCT04396379

Epicardial Mitral Touch System for Mitral Insufficiency

ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Mitre Medical Corp. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Mitral Touch Systems 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.

Conditions

• Ischemic Mitral Regurgitation
• Functional Mitral Regurgitation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-10
• Primary completion: 2024-12-30
• Completion: 2027-12-31
• First posted: 2020-05-20
• Last updated: 2023-01-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study