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Transventricular Off-pump Mitral Valve Repair (TRANSOM) for Mitral Regurgitation

This study is testing a new, less invasive way to repair a heart valve called the mitral valve. This procedure, called TRANSOM, helps people with severe mitral regurgitation (when the mitral valve doesn't close properly, causing blood to leak backward). Instead of a large incision, TRANSOM uses a small cut between the ribs and repairs the valve while your heart is still beating. The study aims to see how safe TRANSOM is within 30 days and how well it prevents problems like continued leakage or needing another surgery for up to one year. You might be able to join if you are 21 or older, have severe mitral regurgitation, and your valve anatomy is suitable for this repair. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 175 participants. The study is assessing a device called TRANSOM.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for about 30 days or until hospital discharge. Effectiveness will be measured for one year after the procedure.

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NCT07726173

Transventricular Off-pump Mitral Valve Repair

Recruiting
NAAges 21+InterventionalTreatment
Johns Hopkins University
~175 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:TRANSOM

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint: Composite Freedom from Major Adverse Events
Measured over 30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
+1 more outcome measured

Conditions

Mitral Valve (MV) Regurgitation

Explore related trials

Mitral Valve Insufficiency

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • James Gammie, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Lisa Fornaresio, PhD
[email protected]
443.927.3984
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Primary Safety Endpoint: Composite Freedom from Major Adverse Events30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure

    Freedom from a composite of major adverse events including all-cause mortality, all stroke, acute kidney injury (AKI), major bleeding, new permanent pacemaker implantation, deep sternal wound infection (DSWI) or access site infection requiring surgical intervention, and prolonged mechanical ventilation.

  • Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention1 year post-index procedure.

    Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve.