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

NCT07655505 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: ISI dV5 MVr-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Mitral Regurgitation (MR)

Keywords

Mitral Valve Regurgitation; Mitral Valve Disorder; Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Mitral valve repair including the use of force feedback instruments

EXPERIMENTAL

Patients with moderate-severe or severe mitral regurgitation resulting from primary (degenerative) etiology who are candidates for robotic-assisted mitral valve repair.

Device: Mitral Valve Repair including the use of Force Feedback instruments

Interventions

Mitral Valve Repair including the use of Force Feedback instruments DEVICE

Robotic-assisted mitral valve repair including the use of Force Feedback instruments

Mitral valve repair including the use of force feedback instruments

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).
• Subjects that are able to provide written informed consent using the study informed consent form prior to the study.
• Subjects that are willing to comply with protocol-specified follow-up visits.
• 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.

You may not qualify if:

• 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).
• Subjects requiring surgery with multiple stages (i.e., mitral repair cannot be completed in a single procedure).
• Subject with planned major concomitant surgery for a different medical condition (e.g., coronary artery bypass, cancer resection unrelated to mitral regurgitation).
• Subjects with non-reparable anatomy.
• Subjects with severe pulmonary hypertension (systolic Pulmonary Artery Pressure \>70 mmHg).
• Subjects with severe renal insufficiency (estimated Glomerular Filtration Rate \<30 mL/min/1.73m²) or liver failure (Child-Pugh C).
• Subjects with active infection.
• Subjects with contraindication to anesthesia/surgery (e.g., severe frailty, uncorrectable coagulopathy).
• Subjects with any past or ongoing condition, or personal circumstance, that in the Investigator's judgment places the Subject at high surgical risk, deems them unsuitable for mitral valve repair, or might interfere with study participation or data collection (e.g., severe chronic obstructive pulmonary disease, uncontrolled diabetes, immunocompromised state, non-compliance).
• Subjects with severe aortic/tricuspid valve disease requiring concurrent open surgery.
• Subjects who are pregnant, suspected pregnancy, or breastfeeding.
• Subjects currently participating in another investigational drug/device study or participation in a significant-risk investigational device study within the past 6 months.

Sponsors & Collaborators

• Intuitive Surgical: lead

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Jennifer McCrea

CONTACT

303-956-0363; jennifer.mccrea@intusurg.com

Manish Bharara

CONTACT

manish.bharara@intusurg.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 18, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share