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Robotic surgery gets a sense of touch for heart valve repair
NCT ID NCT07655505
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 6 times
Summary
This study tests whether special force feedback instruments, used with the da Vinci surgical robot, can safely and effectively repair leaky mitral valves. The trial includes 30 adults with moderate-to-severe mitral regurgitation. Researchers will check for major complications and measure how well the valve is fixed after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Force Feedback instruments with da Vinci Surgical System
- What this could lead to
- If successful, this could make robotic mitral valve repair safer and more effective, potentially improving outcomes for people with leaky heart valves.
- What could go wrong
- This is a small early study with only 30 participants, so results may not apply to everyone. The technology may not reduce complications or improve repair success compared to standard surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 EXCLUSION CRITERIA: 1. Subjects with symptomatic mitral regurgitation determined to be at prohibitive risk for mitral valve surgery. 2. Subjects with previous mitral valve surgery, transcatheter repair, or annuloplasty. 3. Subjects with prior cardiac surgery (endoscopic, open, or robotic) or ipsilateral thoracic surgery (open, endoscopic, or robotic). 4. Subjects with planned emergent procedure (e.g., cardiogenic shock, acute decompensation requiring immediate surgery). 5. Subjects requiring surgery with multiple stages (i.e., mitral repair cannot be completed in a single procedure). 6. Subject with planned major concomitant surgery for a different medical condition (e.g., coronary artery bypass, cancer resection unrelated to mitral regurgitation). 7. Subjects with non-reparable anatomy. 8. Subjects with severe pulmonary hypertension (systolic Pulmonary Artery Pressure \>70 mmHg). 9. Subjects with severe renal insufficiency (estimated Glomerular Filtration Rate \<30 mL/min/1.73m²) or liver failure (Child-Pugh C). 10. Subjects with active infection. 11. Subjects with contraindication to anesthesia/surgery (e.g., severe frailty, uncorrectable coagulopathy). 12. 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). 13. Subjects with severe aortic/tricuspid valve disease requiring concurrent open surgery. 14. Subjects who are pregnant, suspected pregnancy, or breastfeeding. 15. Subjects currently participating in another investigational drug/device study or participation in a significant-risk investigational device study within the past 6 months. 16. Subject with inability to complete follow-up (e.g., geographic inaccessibility, dementia). 17. Subjects who belong to a vulnerable population (e.g., prisoners, cognitively impaired individuals unable to consent). INTRAOPERATIVE EXCLUSION CRITERIA: 1. Subject with hemodynamic or respiratory instability that precludes the Investigator from performing the Robotic Assisted Surgery (RAS). 2. Subject in whom inadequate visualization makes a minimally invasive approach not feasible, as determined by the Investigator assessment prior to docking the robot. 3. 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. 4. Subject has any other condition that, in the judgment of the Investigator, might interfere with the collection of complete quality data.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory University
RECRUITINGAtlanta, Georgia, 30342, United States
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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Providence Sacred Heart Medical Center
RECRUITINGSpokane, Washington, 99204, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a clip fix a leaky heart valve without open surgery?
- Heart scan report prompts aim to boost specialist referrals
- New heart valve fix without open surgery: early trial begins
- Heart valve repair device tracked for 10 years in new study
- Heart surgery showdown: which repair works best for kids with leaky valves?
- AI reads heart ultrasound videos to pick best candidates for valve repair