Skip to content

Donors After Circulatory Death Heart Trial

Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03831048
Enrollment
180
Registered
2019-02-05
Start date
2019-11-26
Completion date
2021-09-28
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplant

Keywords

Heart preservation, Beating heart transplant

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.

Interventions

Preserving and assessing donor after circulatory death hearts for transplant

Active comparator intervention

Sponsors

TransMedics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Donor Inclusion * Maastricht Category III DCD donor, defined as expected death after the withdrawal of life- supportive therapy (WLST) * Donor age 18-49 years old inclusive * Warm ischemic time (WIT) ≤ 30 mins, with warm ischemic time defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor. Donor Exclusion * Previous cardiac surgery * Known coronary artery disease * Cardiogenic shock or myocardial infarction, or * Sustained terminal ejection fraction (EF) of ≤ 50%, or * Significant valve disease except for competent bicuspid aortic valve Recipient Inclusion * 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' United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data. Recipient Exclusion * Prior solid organ or bone marrow transplant * Chronic use of hemodialysis or diagnosis of chronic renal insufficiency * Multi-organ transplant * Investigator unwilling to randomize to either arm.

Design outcomes

Primary

MeasureTime frameDescription
Survival6 monthsPatient survival 6 months post-transplant

Secondary

MeasureTime frameDescription
Utilization RateWithin 24 hours post-transplantUtilization 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
DCD Heart
OCS Heart System: Preserving and assessing donor after circulatory death hearts for transplant
90
Standard of Care Heart
Cold Storage: Active comparator intervention
90
Total180

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath49
Overall StudyProtocol Violation93
Overall StudyProtocol violation and death11
Overall StudyRe-transplant02

Baseline characteristics

CharacteristicStandard of Care HeartTotalDCD Heart
Age, Continuous55 years
STANDARD_DEVIATION 11.4
52.9 years
STANDARD_DEVIATION 12.8
51.3 years
STANDARD_DEVIATION 12.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
20 Participants48 Participants28 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants4 Participants0 Participants
Race (NIH/OMB)
White
66 Participants128 Participants62 Participants
Sex: Female, Male
Female
24 Participants48 Participants24 Participants
Sex: Female, Male
Male
66 Participants132 Participants66 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
5 / 9010 / 90
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
67 / 900 / 0

Outcome results

Primary

Survival

Patient survival 6 months post-transplant

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DCD HeartSurvival76 Participants
Standard of Care HeartSurvival75 Participants
Comparison: The null and alternative hypotheses for the primary endpoint are as follows:~H0: pSOC - pDCD ≥ 0.20 vs. H1: pSOC - pDCD \< 0.20 where pDCD and pSOC represent the true survival proportions at the six months follow-up visit for DCD and SOC heart transplant patients, respectively.p-value: <0.000190% CI: [-0.098, 0.034]Regression, Linear
Secondary

Utilization Rate

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.

Time frame: Within 24 hours post-transplant

Population: Per protocol, Analysis Population includes DCD donor hearts that met the warm ischemic time limit, then were instrumented on OCS Heart System and transplanted.~The utilization rate is analyzing only the number of hearts instrumented/transplanted, and not number of participants.

ArmMeasureValue (COUNT_OF_UNITS)
DCD HeartUtilization Rate80 Hearts Instrumented
Comparison: No null hypothesis test.

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026