A tiny chest incision, a beating heart: can a new technique fix leaky valves without open surgery?

NCT ID NCT07726173

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

First seen Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial tests a new minimally invasive procedure called TRANSOM for people with a leaky mitral valve, a condition where the valve doesn't close properly. Instead of opening the chest, surgeons make a small incision between the ribs and insert a tube directly into the beating heart to place new cords that help the valve close. The study will evaluate whether this technique is safe and effective compared to standard open-heart surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: a minimally invasive surgical technique called TRANSOM that repairs the mitral valve through a small chest incision while the heart is still beating
What this could lead to: If successful, this technique could offer a less invasive alternative to open-heart surgery for repairing leaky mitral valves, potentially reducing recovery time and complications.
What could go wrong: This is an early-stage trial testing a new surgical approach, so its safety and effectiveness are not yet proven. Risks include bleeding, stroke, infection, and the need for additional procedures.

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 175 people

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

Started

Jun 2026

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 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: * Age 21 years or older. * Presence of severe degenerative mitral regurgitation confirmed by echocardiography. * Mitral leaflet anatomy suitable for coaptation to allow reduction of mitral regurgitation without undue leaflet tension. * Ability to provide informed consent and willingness to comply with study procedures and follow-up. Exclusion Criteria: * Functional mitral regurgitation. * Severe mitral annular or leaflet calcification. * Significant concomitant valvular disease (e.g., severe aortic stenosis or insufficiency, severe tricuspid regurgitation). * Left ventricular ejection fraction \<30% or severe right ventricular dysfunction. * Requirement for concomitant cardiac surgery. * Prior cardiac valve intervention or structural heart procedure (excluding prior PCI). * Recent major cardiovascular events (e.g., stroke or myocardial infarction within 30 days). * Hemodynamic instability or cardiogenic shock at the time of enrollment. * Significant comorbid conditions that increase procedural risk, including advanced liver disease, severe hematologic abnormalities, or active infection. * Contraindications to study procedures or required medications, including inability to tolerate anticoagulation or transesophageal echocardiography. * Pregnancy, lactation, or planned pregnancy during the study period. * Participation in another investigational device or drug study that could interfere with outcomes. * Life expectancy less than 12 months or any condition that, in the opinion of the investigator, precludes study participation.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Mitral valve (MV) regurgitation are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease mitral valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mitral valve (MV) regurgitation

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
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 ↗
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.

A tiny chest incision, a beating heart: can a new technique fix leaky valves without open surgery?

What the study statuses mean