Transventricular Off-pump Mitral Valve Repair for Degenerative Mitral Regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the TRANSOM technique, an off-pump, minimally invasive repair of the mitral valve by replacing some supporting cords. The procedure is performed through a small chest incision without a sternotomy. Eligible participants are adults with severe degenerative mitral regurgitation and suitably aligned valve anatomy. The trial will assess safety and effectiveness, with follow-up assessments to monitor valve function and clinical outcomes. It excludes patients with functional mitral regurgitation, extensive valve calcification, significant other valvular disease, or poor overall cardiac function.

Why it matters

Who can join: the full rules

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.

Where it's running

• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: James Gammie, MD — Johns Hopkins University
• Study coordinator: Lisa Fornaresio, PhD
• Email: lisa.fornaresio@jhmi.edu
• Phone: 443.927.3984

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.