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NCT07726173
Transventricular Off-pump Mitral Valve Repair
Conditions: Mitral Valve (MV) Regurgitation
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 175
Sponsor: Johns Hopkins University
Location: Johns Hopkins Hospital Baltimore Maryland
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.
Eligibility Criteria
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 ventricular ejection fraction \
Source: ClinicalTrials.gov (NCT07726173). StuddyBuddy aggregates publicly available trial information.