Mitral Regurgitation (MR)NCT07655505
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
A study testing Mitral Valve Repair including the use of Force Feedback instruments in people with Mitral Regurgitation (MR), run by Intuitive Surgical at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Mitral Regurgitation (MR)
- What is being tested?
- Mitral Valve Repair including the use of Force Feedback instruments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Jul 2026to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- PREOPERATIVE EXCLUSION CRITERIA:
- 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).
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- 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.
- Subject with inability to complete follow-up (e.g., geographic inaccessibility, dementia).
- Subjects who belong to a vulnerable population (e.g., prisoners, cognitively impaired individuals unable to consent).
- INTRAOPERATIVE EXCLUSION CRITERIA:
- Subject with hemodynamic or respiratory instability that precludes the Investigator from performing the Robotic Assisted Surgery (RAS).
- Subject in whom inadequate visualization makes a minimally invasive approach not feasible, as determined by the Investigator assessment prior to docking the robot.
- Subject with adhesions, scarring, and disease status in the body which, in the opinion of the investigator, limits the ability to perform the minimally invasive procedure.
- Subject has any other condition that, in the judgment of the Investigator, might interfere with the collection of complete quality data.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Manish Bharara contact
United States3 sites, 3 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30342
Clinical Study Coordinator, OCR@Emory.edu
Douglas Murphy, MD
- Recruiting
NYU Langone Health
New York, New York, 10016
Jackie Bott, RN, 212-263-2268, Jacqueline.Bott@nyulangone.org
Didier Loulmet, MD
- Recruiting
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Lauren Study Coordinator, 509-474-4345, lauren.wilcox@providence.org
Justin Reeves, MD
About this study
Official title: 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)
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)
- Being tested
- Mitral Valve Repair including the use of Force Feedback instruments
- Keywords
- Mitral Valve Regurgitation, Mitral Valve Disorder, Mitral Regurgitation
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral Valve Repair including the use of Force Feedback instrumentsDevice
Robotic-assisted mitral valve repair including the use of Force Feedback instruments
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mitral Valve Repair including the use of Force Feedback instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Postoperative Day 2-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start6 Jul 2026
- Primary completion31 Dec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Regurgitation (MR)Studies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655505
- Sponsor's protocol ID
- ISI dV5 MVr-01
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No