Donor After Circulatory Death Heart CAP Trial

TransMedics90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Transplant

Interventions

TransplantDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

University of California San Diago

La Jolla, California, United States

Outcomes

Primary Outcomes

Patient Survival

Patient survival at 6 months post-transplant.

Time frame: 6 months post-transplant

Secondary Outcomes

Utilization Rate

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.

Time frame: 24 hours post transplant

Data from ClinicalTrials.gov

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