Clinical Trial of the Week: Device study for patients with severe mitral valve regurgitation

By Donna Loyle, communications specialist, LIMR

The APOLLO clinical trial is for patients who’ve been diagnosed with severe symptomatic mitral regurgitation and who’ve been told they need mitral valve replacement. This is a multicenter, global, prospective, interventional, pre-market trial with two subject groups randomized on a 1:1 basis to either the study device or to conventional mitral valve surgery.

One group of participants will have the Medtronic Intrepid™ transcatheter mitral valve replacement system (TMVR) implanted in their mitral valve, while the other group will undergo conventional surgical mitral valve replacement.

Additionally, patients who are unable to undergo surgical replacement may qualify for the TMVR procedure.

Subjects are seen at pre- and post-procedure, discharge, 30 days, six months, and annually through five years.

Inclusion criteria:

  • Patient must be deemed a candidate for bioprosthetic mitral valve replacement
  • Must not have prohibitive mitral annular calcification or hemodynamic instability
  • Must not have left ventricular ejection fraction <25%

If you have identified a patient who may benefit from this treatment, an evaluation can be performed by the Structural Heart Team at Lankenau Heart Institute. The principal investigator is Dr. Scott Goldman, and sub-investigators are Drs. William Gray and Sandra Abramson. More information is available at https://www.mainlinehealth.org/research/clinical-trials/3809-apollo

This entry was posted in Clinician News. Bookmark the permalink.

Leave a Reply

Your email address will not be published.