Mitral Regurgitation (MR)
Conditions
Keywords
Mitral Valve Regurgitation, Mitral Valve Disorder, Mitral Regurgitation
Brief 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).
Interventions
DEVICEMitral Valve Repair including the use of Force Feedback instruments
Robotic-assisted mitral valve repair including the use of Force Feedback instruments
Sponsors
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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 \<4%). 5. Subjects that are able to provide written informed consent using the study informed consent form prior to the study. 6. Subjects that are willing to comply with protocol-specified follow-up visits. 7. Subjects must be candidates for minimally invasive surgery (no contraindications to robotic approach). Based on the study Investigator's clinical judgement, the Subject is deemed suitable to undergo multiport robotic-assisted surgery for mitral valve repair.
Exclusion criteria
PREOPERATIVE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse events | 30 days postoperative | 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. |
| Residual Mitral Regurgitation Grade on a Transthoracic Echocardiogram (TTE) | Postoperative Day 2-7 | 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. |
Countries
United States
Contacts
CONTACTJennifer McCrea
CONTACTManish Bharara
Outcome results
None listed