OCS Heart EXPAND + CAP Continued Follow-Up
Sponsor
TransMedics (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05096299
Collaborator
(none)
150
130.5
Study Details
Study Description
Brief Summary
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Heart EXPAND and OCS Heart EXPAND CAP studies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
150 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
OCS Heart EXPAND + CAP Continued Follow-Up Post-Approval Study
Actual Study Start Date
:
Sep 16, 2015
Anticipated Primary Completion Date
:
Aug 1, 2026
Anticipated Study Completion Date
:
Aug 1, 2026
Outcome Measures
Primary Outcome Measures
- Patient survival [5 years post transplant]
Patient survival through 5 years post-transplant
Other Outcome Measures
- Cardiac patient survival [5 years post transplant]
Cardiac related patient survival through 5 years post-transplant
- Graft survival [5 years post transplant]
Graft survival through 5 years post-transplant
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
- Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- TransMedics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
TransMedics
ClinicalTrials.gov Identifier:
NCT05096299
Other Study ID Numbers:
- OCS-HEART-02-PAS
First Posted:
Oct 27, 2021
Last Update Posted:
Nov 11, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes