Clinical Trials at the Frankel Cardiovascular Center

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

• ReCHORD Trial: The purpose of this trial is to obtain clinical data in order to demonstrate that the NeoChord Artificial Chordae Delivery System Model DS1000 is superior to traditional mitral valve surgery in terms of safety and non-inferior in terms of effectiveness for the surgical repair of degenerative mitral valve regurgitation

• APOLLO Trial: The purpose of this trial is to evaluate the safety and efficacy of Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System in patients with at least moderate-to-severe mitral regurgitation who may not be good candidates for transcatheter mitral valve repair or surgical mitral valve intervention:
  https://UMHealthResearch.org/#studies/HUM00179697

• RESTORE Trial: The purpose of this study is to evaluate the safety and effectiveness (usefulness) of the HARPOON™ Beating Heart Mitral Valve Repair System. The HARPOON™ Beating Heart Mitral Valve Repair System, is designed to reduce the degree of mitral regurgitation caused by degenerative mitral valve disease: https://UMHealthResearch.org/#studies/HUM00182827

• REPAIR MR Trial: The purpose of this trial is to evaluate the medical device called the MitraClip™ Mitral Valve Repair System (or the MitraClip system) for an investigational use in patients with severe primary mitral regurgitation who are at moderate surgical risk: https://UMHealthResearch.org/#studies/HUM00186017

• CLASP IID/IIF Pivotal Trial: The goal of this study is to assess the safety and performance of the PASCAL System compared to the MitraClip System in patients with at least moderate-to-severe degenerative or functional mitral regurgitation who may not be ideal candidates for mitral valve surgery and may be eligible for transcatheter mitral valve repair: https://UMHealthResearch.org/#studies/HUM00162937

• TRILUMINATE Pivotal Trial: The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe TR, who are at intermediate or greater estimated risk for mortality with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).
  TRILUMINATE Pivotal Trial: https://UMHealthResearch.org/#studies/HUM00172991
• CLASP II TR Pivotal Trial: This study is designed as a multicenter, randomized, controlled pivotal trial to compare the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System (PASCAL System) and optimal medical therapy (OMT) to OMT alone for patients with symptomatic severe tricuspid regurgitation (TR).
  CLASP II TR Trial: https://UMHealthResearch.org/#studies/HUM00173103
• Triscend II Pivotal Trial: This is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE Transcatheter Tricuspid Valve Repair System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation.
  Triscend Pivotal Trial: https://UMHealthResearch.org/#studies/HUM00191734
• Medtronic Intrepid TTVR Early Feasibility Study:This is a pre-market, multi-center, prospective, non-randomized study. The objective of this early feasibility study is to gain early clinical insight into the performance of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System, intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
  Medtronic Intrepid Study: https://UMHealthResearch.org/#studies/HUM00186532