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
- Are there results?
- Not yet: the study is under way
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).
Show all 23Show fewer
- 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.
United States3 sites
Emory University
Atlanta, Georgia, 30342
NYU Langone Health
New York, New York, 10016
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
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
- Oct 2026
- First submitted
- 10 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07655505
- Acronym / sponsor ID
- ISI dV5 MVr-01
- Conditions
- Mitral Regurgitation (MR)
- Keywords
- Mitral Valve Regurgitation, Mitral Valve Disorder, Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitral valve repair including the use of force feedback instruments | Experimental | Device: Mitral Valve Repair including the use of Force Feedback instrumentsPatients with moderate-severe or severe mitral regurgitation resulting from primary (degenerative) etiology who are candidates for robotic-assisted mitral valve repair. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral Valve Repair including the use of Force Feedback instrumentsRobotic-assisted mitral valve repair including the use of Force Feedback instruments | Device | Mitral valve repair including the use of force feedback instruments |
Primary outcome
Incidence of major adverse events
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Mitral Regurgitation (MR)
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
Not yet recruiting
Early Feasibility Study of NeoChord Transcatheter Mitral Repair System
Degenerative Mitral Regurgitation, Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
RecruitingObservational study
Examination of Nociscan Impact on Low Back Pain Surgical Outcomes
Low Back Pain
Recruiting
EXPLORE MRace (GE): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant
Mitral Valve Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse events (time frame: 30 days postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.