Donor After Circulatory Death Heart CAP Trial

Not Applicable

Completed

• Conditions: Heart Transplant

• Registration Number: NCT04615182
• Lead Sponsor: TransMedics

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)

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.

Study Timeline

• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-11-04
• Study Start: 2020-11-25
• Primary Completion: 2021-12-21
• Study Completion: 2022-06-29
• Status Verified: 2022-09
• Results First Submitted: 2024-05-06
• Results First Submitted QC: 2024-06-18
• Last Update Submitted: 2024-06-18
• Results First Posted: 2024-06-21
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient Survival	6 months post-transplant	Patient survival at 6 months post-transplant.

Secondary Outcome Measures

Name	Time	Method
Utilization Rate	24 hours post transplant	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.

Trial Locations

Locations (25)

University of California San Diago; 🇺🇸 La Jolla, California, United States

Cedars Sinai; 🇺🇸 Los Angeles, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Evanston, Illinois, United States

St. Vincent Cardiovascular Research Institute; 🇺🇸 Indianapolis, Indiana, United States

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