Brief Summary
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
Brief Title
Donor After Circulatory Death Heart CAP Trial
Detailed Description
To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance 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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Heart Transplant
Eligibility Criteria
Recipient Inclusion Criteria:
* • Primary heart transplant candidates
* Age ≥ 18 years old
* Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' UNOS/OPTN data and recipients' INTERMACS data.
Recipient Exclusion Criteria:
* Prior solid organ or bone marrow transplant
* Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
* Multi-organ transplant.
* • Primary heart transplant candidates
* Age ≥ 18 years old
* Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' UNOS/OPTN data and recipients' INTERMACS data.
Recipient Exclusion Criteria:
* Prior solid organ or bone marrow transplant
* Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
* Multi-organ transplant.
Inclusion Criteria
Inclusion Criteria:
* • Primary heart transplant candidates
* Age ≥ 18 years old
* Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' UNOS/OPTN data and recipients' INTERMACS data.
Recipient
* • Primary heart transplant candidates
* Age ≥ 18 years old
* Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' UNOS/OPTN data and recipients' INTERMACS data.
Recipient
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04615182
Org Class
Industry
Org Full Name
TransMedics
Org Study Id
OCS-CAR-08242020
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
Primary Outcomes
Outcome Description
Patient survival at 6 months post-transplant.
Outcome Measure
Patient Survival
Outcome Time Frame
6 months post-transplant
Secondary Outcomes
Outcome Description
Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit per protocol and were instrumented on the OCS Heart System that meet the acceptance criteria for transplantation after OCS Heart preservation divided by the total number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System.
Outcome Time Frame
24 hours post transplant
Outcome Measure
Utilization Rate
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Daniel Goldstein
Investigator Email
dgoldste@montefiore.org
Investigator Phone