Donors After Circulatory Death Heart Trial

Not Applicable

Completed

• Conditions: Heart Transplant
• Interventions: Device: OCS Heart System; Other: Cold Storage

• Registration Number: NCT03831048
• Lead Sponsor: TransMedics

Brief Summary

To evaluate the effectiveness 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.

Detailed Description

A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (Standard of Care 1 \[SOC1\] and Standard of Care 2 \[SOC2\] - from both randomized and concurrent control groups), adjusting for differences in risk factors.

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Study Start: 2019-11-26
• Primary Completion: 2021-04-01
• Study Completion: 2021-09-28
• Status Verified: 2022-12
• Results First Submitted: 2023-12-05
• Results First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Results First Posted: 2024-05-07
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCD Heart Possible	OCS Heart System	-
Standard of Care Heart Only	Cold Storage	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Utilization Rate	Within 24 hours post-transplant	Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit above 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)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

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

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

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

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

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

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Montefiore; 🇺🇸 Bronx, New York, United States

Westchester Medical Center; 🇺🇸 Valhalla, New York, United States

Nyph/Cumc; 🇺🇸 New York, New York, United States

Sentara; 🇺🇸 Norfolk, Virginia, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

Minneapolis Heart Institute; 🇺🇸 Minneapolis, Minnesota, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

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

Duke University; 🇺🇸 Durham, North Carolina, United States

AdventHealth; 🇺🇸 Orlando, Florida, United States

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

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

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Virgina Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Froedtert & the Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States