This study aims to test the safety and effectiveness of Force Feedback instruments used during robotic-assisted mitral valve repair with the da Vinci Surgical System, Model IS5000 (dV5).
Age ≥22 years.
Subjects with mitral regurgitation (MR) resulting from primary (degenerative) etiology with normal ventricular function (left ventricular function > 40%) provided that annuloplasty or ventricular repair is feasible robotically.
Subjects with moderate-severe (Grade 3) or severe (Grade 4) mitral regurgitation (MR) confirmed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) within 60 days of surgery or evaluation for surgery.
Subjects with low-moderate operative risk (Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of <4%).
Subjects with symptomatic mitral regurgitation determined to be at prohibitive risk for mitral valve surgery.
Subjects with previous mitral valve surgery, transcatheter repair, or annuloplasty.
Subjects with prior cardiac surgery (endoscopic, open, or robotic) or ipsilateral thoracic surgery (open, endoscopic, or robotic).
Subjects with planned emergent procedure (e.g., cardiogenic shock, acute decompensation requiring immediate surgery).
Single group
Mitral Valve Repair including the use of Force Feedback instruments
DeviceRobotic-assisted mitral valve repair including the use of Force Feedback instruments
Incidence of major adverse events
The primary safety endpoint will be evaluated by the incidence of major (Clavien-Dindo Grade III or higher) adverse events related to the use of Force Feedback instruments during robotic-assisted mitral valve repair.
Residual Mitral Regurgitation Grade on a Transthoracic Echocardiogram (TTE)
The primary effectiveness endpoint will be evaluated as residual mitral regurgitation of moderate (Grade 2) or less measured by an echocardiogram after robotic-assisted mitral valve repair.
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