About this trial
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).
Eligibility criteria
Qualifiers
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%).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Mitral Valve Repair including the use of Force Feedback instruments