Transventricular Off-pump Mitral Valve Repair (TRANSOM)
Johns Hopkins University
Summary
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.
Description
The key advantages of TRANSOM are that it is less invasive, requiring a small non-rib-spreading chest incision rather than a sternotomy, which splits the breastbone.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 21 years or older. * Presence of severe degenerative mitral regurgitation confirmed by echocardiography. * Mitral leaflet anatomy suitable for coaptation to allow reduction of mitral regurgitation without undue leaflet tension. * Ability to provide informed consent and willingness to comply with study procedures and follow-up. Exclusion Criteria: * Functional mitral regurgitation. * Severe mitral annular or leaflet calcification. * Significant concomitant valvular disease (e.g., severe aortic stenosis or insufficiency, severe tricuspid regurgitation). * Left ventri…
Interventions
- DeviceTRANSOM
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.
Location
- Johns Hopkins HospitalBaltimore, Maryland