Clinical Trials Logo

Clinical Trial Summary

To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.


Clinical Trial Description

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 (Standard of Care 1 [SOC1] and Standard of Care 2 [SOC2] - from both randomized and concurrent control groups), adjusting for differences in risk factors. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03831048
Study type Interventional
Source TransMedics
Contact
Status Completed
Phase N/A
Start date November 26, 2019
Completion date September 28, 2021

See also
  Status Clinical Trial Phase
Completed NCT02964026 - Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients N/A
Active, not recruiting NCT05096299 - OCS Heart EXPAND + CAP Continued Follow-Up
Completed NCT02323321 - International EXPAND Heart Pivotal Trial N/A
Recruiting NCT05933083 - MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation N/A
Completed NCT03150095 - Health Coaching to Improve Self-Management in Thoracic Transplant Candidates N/A
Active, not recruiting NCT02554578 - Impact of mHealth in Heart Transplant Management N/A
Terminated NCT03346278 - Text Message Intervention to Improve Cardiac Rehab Participation N/A
Active, not recruiting NCT05741723 - OCS DCD Heart + CAP Continued Follow-Up
Completed NCT04615182 - Donor After Circulatory Death Heart CAP Trial N/A
Completed NCT02597543 - Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction Phase 4
Recruiting NCT05824364 - Exercise aNd hEArt Transplant N/A
Not yet recruiting NCT05025774 - Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant BPD Through Exercise
Enrolling by invitation NCT05390411 - Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial N/A
Recruiting NCT04770012 - AERIAL Trial: Antiplatelet Therapy in Heart Transplantation Phase 3
Terminated NCT01769443 - Safety and Efficacy of Desensitization Therapy in Sensitized Participants Awaiting Heart Transplantation Phase 2
Completed NCT00466804 - Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients N/A
Not yet recruiting NCT05459181 - HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC) N/A
Terminated NCT01485757 - Prospective L-arginine Study Phase 1
Active, not recruiting NCT01186250 - Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation Phase 2
Completed NCT00812786 - Pharmacokinetics of Immunosuppressive Drugs in Heart Transplant Patients Phase 4