Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair

Sex: All

Ages: 22 Years – N/A

Healthy volunteers: No

Phase: NA

Enrollment: 30

Sponsor: Intuitive Surgical

Summary

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

Inclusion Criteria: 1. Age ≥22 years. 2. 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. 3. 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. 4. Subjects with low-moderate operative risk (Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07655505). StuddyBuddy aggregates publicly available trial information.