Donor After Circulatory Death Heart CAP Trial

TransMedics

Status: Completed

Conditions: Heart Transplant

Treatments: Device: Transplant

Study type: Interventional

Funder types: Industry

Identifiers

NCT04615182

OCS-CAR-08242020

Details and patient eligibility

About

The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

OCS Preservation

Experimental group

Treatment:

Device: Transplant