Heart Transplant Clinical Trial
— EXPANDHeartOfficial title:
International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND Heart Trial)
Verified date | August 2019 |
Source | TransMedics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation
Status | Completed |
Enrollment | 75 |
Est. completion date | March 2, 2019 |
Est. primary completion date | April 25, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Registered male or female primary Heart transplant candidate - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Spectrum Health | Grand Rapids | Michigan |
United States | Indiana University | Indianapolis | Indiana |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | Minneapolis Heart Institute | Minneapolis | Minnesota |
United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Mount Sinai | New York | New York |
United States | University of Washington Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
TransMedics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A composite endpoint of patient survival at Day-30 post transplant and absence of severe primary heart graft dysfunction in the first 24 hours post-transplantation | 30 Days |
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
|
||
Not yet recruiting |
NCT05025774 -
Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant BPD Through Exercise
|
||
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 |
NCT03831048 -
Donors After Circulatory Death Heart Trial
|
N/A | |
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 | |
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 | |
Recruiting |
NCT06426173 -
Effect of Resistance Training in Patients on the Waiting List for Heart Transplant
|
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 |