Transventricular Off-pump Mitral Valve Repair for Mitral Regurgitation
Transventricular Off-pump Mitral Valve Repair
Recruiting
N/AInterventional Study
Mitral Valve (MV) Regurgitation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
175 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for adults with severe mitral valve regurgitation due to a faulty valve leaflet. Participants will undergo a new, less invasive procedure to repair their mitral valve.
Are You a Good Fit for This Trial?
Rules you outFunctional mitral regurgitationSevere mitral annular or leaflet calcificationSignificant concomitant valvular diseaseSevere right ventricular dysfunctionRecent major cardiovascular eventsHemodynamic instabilitySignificant comorbid conditionsPregnancy or lactation
You may be able to join if
I am 21 years old or older.
I have severe degenerative mitral regurgitation confirmed by an echocardiogram.
My mitral valve leaflet anatomy is suitable for the procedure.
I can give informed consent and will follow study procedures.
You may not be able to join if
I have functional mitral regurgitation.
I have severe calcification of the mitral valve or annulus.
I have significant other valvular heart disease.
My left ventricular ejection fraction is less than 30%.
I need another heart surgery at the same time.
I have had a major cardiovascular event in the last 30 days.
I am currently unstable or in cardiogenic shock.
I have any significant health conditions that increase risks for the procedure.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this study is to assess the safety and effectiveness (usefulness) of an investigational technique used to repair the mitral valve for patients with mitral regurgitation due to a defective valve leaflet. This procedure is called trans-ventricular off-pump mitral valve repair (TRANSOM) and it repairs the mitral valve by replacing some of the cords that support the mitral valve. This t…
The purpose of this study is to assess the safety and effectiveness (usefulness) of an investigational technique used to repair the mitral valve for patients with mitral regurgitation due to a defective valve leaflet. This procedure is called trans-ventricular off-pump mitral valve repair (TRANSOM) and it repairs the mitral valve by replacing some of the cords that support the mitral valve. This type of repair is minimally-invasive since it is performed through a small incision and avoids making a breast-bone-splitting incision.
Trial Locations
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Eligibility Criteria
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 wil…
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.
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