Transventricular Off-pump Mitral Valve Repair

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07726173
Status
Recruiting
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Conditions

  • Mitral Valve (MV) Regurgitation

Eligibility Criteria

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

Interventions

  • TRANSOM — DEVICE
    TRANSOM is a minimally-invasive treatment that involves making a small incision between the ribs of the left chest, inserting a thin tube directly into the heart while it is beating, and placing the suture material onto the edges of the valve flaps so that the valves come together properly.

Study Details

The purpose of this study is to assess the safety and effectiveness (usefulness) of an investigational technique used to repair the mitral valve for patients with mitral regurgitation due to a defective valve leaflet. This procedure is called trans-ventricular off-pump mitral valve repair (TRANSOM) and it repairs the mitral valve by replacing some of the cords that support the mitral valve. This type of repair is minimally-invasive since it is performed through a small incision and avoids making a breast-bone-splitting incision.

Key Dates

First listed
Jul 24, 2026
Start date
Jun 8, 2026
Status verified
Jul 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2029

Study Design

Enrollment
175 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Transventricular off-pump mitral valve repair
    Participants with severe degenerative mitral regurgitation will undergo transventricular off-pump mitral valve repair for the treatment of degenerative mitral regurgitation.

Primary Outcome Measure

Primary Safety Endpoint: Composite Freedom from Major Adverse Events [ Time Frame: 30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Lisa Fornaresio, PhD
[email protected]
443-927-3984
Rachael Quinn, PhD
[email protected]
410.955.2800
James S. Gammie, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins Hospital· Baltimore, MD

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