Mitral And Tricuspid Program (MATRIx) Clinical Trials

The Michigan Medicine Frankel Cardiovascular Center’s Percutaneous Mitral And Tricuspid (MATRIx) program is at the forefront of minimally invasive and endovascular treatment technologies for mitral valve and tricuspid valve repair and replacement.   

With the goal of advancing the fight against cardiovascular disease, our team is leading the way in exciting clinical trials focused on the treatment of mitral and tricuspid valves. These include:

Mitral Valve Trials

  • Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study: An early feasibility study of mitral valve replacement using a new experimental device:
    TMVR Pilot Study: https://clinicaltrials.gov/ct2/show/NCT02428010
  • Transcatheter Mitral Valve Replacement with Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation (TMVR APOLLO Trial): A study to determine if replacing the mitral valve using a transcatheter approach is as safe and effective as standard mitral valve surgery:
    TMVR APOLLO Trial: https://clinicaltrials.gov/ct2/show/NCT03242642
  • Randomized Trial of the NeoChord DS1000 System Versus Open Surgical Repair: A study to determine if the NeoChord DS1000 System, which delivers sutures to the mitral valve via a transcatheter approach, is safe and effective to reduce mitral regurgitation when compared with open surgical repair.
    NeoChord DS1000: Trial: https://clinicaltrials.gov/ct2/show/NCT02803957
  • Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial: A study to assess the safety and performance of the PASCAL System compared to the MitraClip System in patients with moderate to severe mitral regurgitation who may not be ideal candidates for mitral valve surgery and may be eligible for transcatheter mitral valve repair.
    PASCAL CLASP IID/IIF Pivotal Trial: https://clinicaltrials.gov/ct2/show/NCT03706833
  • The CARILLON Trial – Assessment of the Carillon® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated with Heart Failure: A study to evaluate the safety and effectiveness of the CARILLON Mitral Contour System in patients with mitral regurgitation resulting from heart failure.
    CARILLON Trial: https://clinicaltrials.gov/ct2/show/NCT03142152

Tricuspid Valve Trials

  • TRILUMINATE Pivotal Trial: A study to assess the safety and performance of the TriClip™ plus optimal drug therapy compared to optimal drug therapy along in patients with symptomatic moderate or greater tricuspid regurgitation who may not be ideal candidates for surgery and may be eligible for Transcatheter tricuspid valve repair. 
    TRILUMINATE Pivotal Trial: https://clinicaltrials.gov/ct2/show/NCT03904147
  • Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR): A study to evaluate the safety and performance of the PASCAL System with optimal medical therapy (OMT) compared to OMT alone in patients with symptomatic severe tricuspid regurgitation who may not be ideal candidates for surgery and may be eligible for transcatheter repair.
    CLASP II TR Trial: https://clinicaltrials.gov/ct2/show/NCT04097145

Other Trials

To learn more about other clinical trials at Michigan Medicine, visit UMHealthResearch.org.

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