Epicardial Mitral Touch System for Mitral Insufficiency

Part of paid clinical trials in Plano, Texas.

Sponsor
Mitre Medical Corp.
Study ID
NCT04396379
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Functional Mitral Regurgitation
  • Ischemic Mitral Regurgitation

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Implant an epicardial device to reshape the mitral valve annulus — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 10, 2023
Status verified
Jan 2023
Primary completion
Dec 30, 2024
Completion
Dec 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Device Implantation
    To epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy) using an epicardial implant.

Primary Outcome Measure

Rate of Freedom from Major Adverse Events [ Time Frame: Procedure through 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor Scott and WhitePlanoTexas75093
Robert L. Smith, MD
[email protected]
469-814-3278
Robert L. Smith, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Plano, TX

By research site
Baylor Scott and White· Plano, TX

Related Studies