Heart TransplantNCT04615182

Donor After Circulatory Death Heart CAP Trial

A study testing Transplant in people with Heart Transplant, run by TransMedics at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Transplant
What is being tested?: Transplant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 25 sitesUnited States
Study dates: 25 Nov 2020to 29 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Emory University Hospital
Atlanta, Georgia, 30322
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Duke University
Durham, North Carolina, 27710
Northwestern University
Evanston, Illinois, 60208
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, 46260
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of California San Diago
La Jolla, California, 92037
Cedars Sinai
Los Angeles, California, 90048
University of Wisconsin
Madison, Wisconsin, 53792
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
University of Minnesota
Minneapolis, Minnesota, 55455-0213
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Yale New Haven Hospital
New Haven, Connecticut, 06510
Nyph/Cumc
New York, New York, 10032
Sentara
Norfolk, Virginia, 23502
University of Nebraska Medical Center
Omaha, Nebraska, 68198
AdventHealth Orlando
Orlando, Florida, 32803
Stanford University
Palo Alto, California, 94304
Virginia Commonwealth University
Richmond, Virginia, 23219
Tampa General Hospital
Tampa, Florida, 33606
Montefiore
The Bronx, New York, 10467
Westchester Medical Center
Valhalla, New York, 10595

Other trials in United States

About this study

Official title: The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)

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

Read the 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.

Conditions: Heart Transplant
Being tested: Transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TransplantDevice
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 groups in NCT04615182
Study group	Role	What they receive
OCS Preservation	Experimental	Not described Receives: Device: Transplant

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Survival
Patient survival at 6 months post-transplant.
Measured: 6 months post-transplant

Secondary outcomes (1)

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.
Measured: 24 hours post transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Nov 202029 Jun 2022

First posted4 Nov 2020
Study start25 Nov 2020
Primary completion21 Dec 2021
Study completion29 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart TransplantStudies of the same condition, open and under way.
More trials run by TransMedicsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04615182
Sponsor's protocol ID: OCS-CAR-08242020
Status last verified: Sep 2022
First submitted: 28 Oct 2020
Last updated: 21 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)

All Heart Transplant trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
ClinicalTrials.gov ID: NCT04615182
Acronym / sponsor ID: OCS-CAR-08242020
Conditions: Heart Transplant
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: TransMedicsIndustry (pharma, biotech, devices)
Study start: 25 Nov 2020 (actual)
Primary completion: 21 Dec 2021 (actual)
Study completion: 29 Jun 2022 (actual)
First posted: 4 Nov 2020 (actual)
Results: Posted 21 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OCS Preservation	Experimental	Device: Transplant

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TransplantTo 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.	Device	OCS Preservation

Primary outcome

Patient Survival
Time frame: 6 months post-transplant
Patient survival at 6 months post-transplant.

1 secondary outcome

Utilization Rate
Time frame: 24 hours post transplant

Results and safety

Results posted to the registry on 21 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OCS Preservation	90	75

Primary outcome: Patient Survival

Time frame: 6 months post-transplant. Count of participants. Unit: Participants

Measure	OCS Preservation n = 81
Value	75

Population analysed: Per protocol population reported. Two subjects were withdrawn due to re-transplant and were excluded from the analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Serious adverse events will be collected only through Day 30 post-transplant. All-cause mortality was evaluated through 6-months post-transplant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OCS Preservation	53 of 90 (58.9%)	0 of 0	7 of 90

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heart Transplant

RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transplant in people with Heart Transplant, run by TransMedics at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Survival (time frame: 6 months post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04615182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.