RecruitingNCT07655505
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
AI Description
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).
- Who can join
- adult, older adult
- Participants
- 30
- Expected completion
- 2027-06
- Funded by
- industry
Conditions studied
Mitral Regurgitation (MR)
What is being tested
- DEVICE: Mitral Valve Repair including the use of Force Feedback instruments
What it measures
- 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., 30 days postoperative
- 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., Postoperative Day 2-7
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2026-09-14
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.