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OCS™ Heart U.S. DCD Heart Trial


Title Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death (OCS™ Heart U.S. DCD Heart Trial)
Therapeutic Area Transplant
Principal Investigator Gregory Couper, MD
Min Age 18 Years
Max Age 65 Years
Gender All
Contact Vanessa Palomo
617-636-9334
vpalomo@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04615182

Overview

A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (SOC1 and SOC2 - from both randomized and concurrent control groups), adjusting for differences in risk factors.

Study Details

Inclusion Criteria

  • Primary heart transplant candidates
  • Age ≥ 18 years old

Exclusion Criteria

  • Prior solid organ or bone marrow transplant
  • Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
  • Multi-organ transplant
  • Investigator unwilling to randomize to either arm.

Study Requirements

After transplant, patients will be assessed for the first 30 days. Inotropic Support, Right Heart Catherer Results, Mechanical Circulatory Support,and Patient and Graft Survival will be assessed at time of transplant, and 24 hours. An echocardiogram will be done at 24 hours. Mechanical and Circulatory Support, and Patient and Graft Survival will be assessed at 72 hours post transplant. Follow-up data collection will be conducted at 6 months and 12 months post-transplant to evaluate patient survival, graft survival and diagnosis of cardiac allograft vasculopathy. These follow-ups may be performed by phone.