Heart TransplantNCT05096299
OCS Heart EXPAND + CAP Continued Follow-Up
An observational study of Heart Transplant, run by TransMedics.
Trial summary
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Heart EXPAND and OCS Heart EXPAND CAP studies. 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?
- OCS Heart
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2015to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials will comprise the patient population for this PAS.
Who may be able to join
- Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials
Who cannot join
None listed.
About this study
Official title: OCS Heart EXPAND + CAP Continued Follow-Up Post-Approval Study
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Heart EXPAND and OCS Heart EXPAND CAP studies.
- Conditions
- Heart Transplant
- Being tested
- OCS Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS HeartDevice
Transplanted with OCS preserved heart.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
Patient survival through 5 years post-transplant
Measured: 5 years post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start16 Sep 2015
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096299
- Sponsor's protocol ID
- OCS-HEART-02-PAS
- Status last verified
- Apr 2025
- First submitted
- 15 Oct 2021
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCS Heart EXPAND + CAP Continued Follow-Up Post-Approval Study
- ClinicalTrials.gov ID
- NCT05096299
- Acronym / sponsor ID
- OCS-HEART-02-PAS
- Conditions
- Heart Transplant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Heart EXPAND and OCS Heart EXPAND CAP studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials will comprise the patient population for this PAS.
Key inclusion criteria (1 listed)
- Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OCS HeartTransplanted with OCS preserved heart. | Device | – |
Primary outcome
Patient survival
Time frame: 5 years post transplant
Patient survival through 5 years post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant, run by TransMedics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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: 5 years post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2025.