Overview
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
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 \<30% or severe right ventricular dysfunction.
- Requirement for concomitant cardiac surgery.
- Prior cardiac valve intervention or structural heart procedure (excluding prior PCI).
- Recent major cardiovascular events (e.g., stroke or myocardial infarction within 30 days).
- Hemodynamic instability or cardiogenic shock at the time of enrollment.
- Significant comorbid conditions that increase procedural risk, including advanced liver disease, severe hematologic abnormalities, or active infection.
- Contraindications to study procedures or required medications, including inability to tolerate anticoagulation or transesophageal echocardiography.
- Pregnancy, lactation, or planned pregnancy during the study period.
- Participation in another investigational device or drug study that could interfere with outcomes.
- Life expectancy less than 12 months or any condition that, in the opinion of the investigator, precludes study participation.
