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Donors After Circulatory Death Heart Trial

NCT03831048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-05-07

Study results available
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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.

Conditions

  • Heart Transplant

Interventions

DEVICE

OCS Heart System

Preserving and assessing donor after circulatory death hearts for transplant

OTHER

Cold Storage

Active comparator intervention

Sponsors & Collaborators

  • TransMedics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-26
Primary Completion
2021-04-01
Completion
2021-09-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831048 on ClinicalTrials.gov