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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorIntuitive Surgical

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

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators