Clinical Trials at the Frankel Cardiovascular Center

To view all Cardiovascular Clinical Trials, visit UMHealthResearch.org and click on the "Cardiovascular Studies" tile, or go directly to the list of cardiovascular studies on umcvc.org.

COVID-19 Inpatient Trials

Mesenchymal Stem Cell Trial

PI: Jonathan Golob, M.D. & CO-I Francis Pagani, M.D.

MSCs in COVID-19 ARDS

https://umhealthresearch.org/#studies/HUM00180086

https://clinicaltrials.gov/ct2/show/NCT04371393                                    

The purpose of this trial is to determine whether MSCs (mesenchymal stromal cells) are effective and safe in helping patients with moderate to severe ARDS due to COVID-19 infection. The MSCs used in this study are called remestemcel-L, and these human stem cells are derived from the bone marrow of healthy volunteers and cultured (grown) in a laboratory. This treatment is experimental, meaning that it has not been approved by the Food and Drug Administration (FDA) as a treatment for ARDS. The treatment is being developed by Mesoblast for the treatment of multiple diseases including ARDS due to COVID-19 Infection. Patients are still eligible for this trial if they are receiving remdesivir outside of a clinical trial.

Inclusion Criteria:

  • 18 years or older
  • Patient requiring mechanical ventilator support with moderate to severe ARDS

Exclusion Criteria:

  • Patients who have intubated for more than 72 hours
  • Patients currently receiving ECMO or HFOVaccep

DICER Trial

PI: Yogendra Kanthi, M.D. & CO-I Jason Knight, M.D.

Dipyridamole to Arrest Progression of Mild/moderate CoV-19 infection DICER

https://UMHealthResearch.org/#studies/HUM00179783

https://clinicaltrials.gov/ct2/show/NCT04391179

The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole (an FDA-approved drug) can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19. This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted to University of Michigan. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.

Inclusion Criteria:

  • 18 years or older
  • Confirmed coronavirus infection, ≤ 72 hours of hospital admission or of COVID-19 confirmation
  • Currently hospitalized or anticipated hospitalization requiring supplemental oxygen ≤ 6 LPM by nasal cannula.

Exclusion Criteria:

  • Unlikely to survive for greater than 48 from screening
  • Currently on invasive mechanical ventilation

Questions

For non-urgent questions about the COVID-19 inpatient trials above, contact CVCVolunteer@med.umich.edu.

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 n/div>ot 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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