A Prospective, Multicenter Clinical Investigation of the Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair (MVr)

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

Age range: 22+ years
Sex: All
Healthy volunteers: No

Detailed 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 Mo…

Interventions

Device
Mitral Valve Repair including the use of Force Feedback instruments
Robotic-assisted mitral valve repair including the use of Force Feedback instruments

Locations (2)

Emory University
Atlanta, Georgia
OCR@Emory.edu
NYU Langone Health
New York, New York
Jacqueline.Bott@nyulangone.org 212-263-2268

A Prospective, Multicenter Clinical Investigation of the Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair (MVr)

Summary

Eligibility

Interventions

Locations (2)

Compensation

Run this study?

Details

Conditions