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Robotic surgery gets a sense of touch for heart valve repair

NCT ID NCT07655505

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

22 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Providence Sacred Heart Medical Center

    RECRUITING

    Spokane, Washington, 99204, United States

More trials for these conditions

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