Clinical Trial of the Week: Device trial to treat mitral valve regurgitation

By Donna Loyle, communications manager, LIMR

 

The new Repair MR randomized controlled trial seeks to compare the clinical outcome of the MitraClip™ device vs. surgical repair in patients with severe primary mitral regurgitation who are at moderate surgical risk and whose mitral valve is suitable for correction.

 

The MitraClip is a device that is guided through a leg vein to the heart and implanted on the mitral valve to help it close more completely, thus helping to restore normal blood flow through the heart.

 

The primary outcomes being measured in this study include:

  • All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at two years
  • Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) at two years

 

Participants are randomized into two study groups. One receives treatment with the MitraClip. The other group receives surgical repair of the mitral valve.

 

The principal investigator for this trial is Basel Ramlawi, MD, and the trial is approved for Lankenau Medical Center. For more, visit www.mainlinehealth.org/research/clinical-trials/repair-mr

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