OCS Heart EXPAND + CAP Continued Follow-Up
April 8, 2025 updated by: TransMedics
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
150
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials will comprise the patient population for this PAS.
Description
Inclusion Criteria:
- Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient survival
Time Frame: 5 years post transplant
|
Patient survival through 5 years post-transplant
|
5 years post transplant
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac patient survival
Time Frame: 5 years post transplant
|
Cardiac related patient survival through 5 years post-transplant
|
5 years post transplant
|
|
Graft survival
Time Frame: 5 years post transplant
|
Graft survival through 5 years post-transplant
|
5 years post transplant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2015
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
October 15, 2021
First Submitted That Met QC Criteria
October 15, 2021
First Posted (Actual)
October 27, 2021
Study Record Updates
Last Update Posted (Actual)
April 9, 2025
Last Update Submitted That Met QC Criteria
April 8, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- OCS-HEART-02-PAS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.