Transventricular Off-pump Mitral Valve Repair for Mitral Regurgitation

Transventricular Off-pump Mitral Valve Repair

Recruiting N/A Interventional Study
Mitral Valve (MV) Regurgitation
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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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 out Functional 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.

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About This Trial
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…
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…
Contacts

Lisa Fornaresio, PhD

443.927.3984

lisa.fornaresio@jhmi.edu

CONTACT

Rachael Quinn, PhD

410.955.2800

rquinn17@jhmi.edu

CONTACT