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NCT05096299 Clinical Trial

OCS Heart EXPAND + CAP Continued Follow-Up

Heart Transplant Clinical Trial

Official title:
OCS Heart EXPAND + CAP Continued Follow-Up Post-Approval Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05096299
Other study ID # OCS-HEART-02-PAS
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 16, 2015
Est. completion date August 2026

Study information
Verified date January 2024
Source TransMedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Post-approval observational study of subjects that were enrolled and transplanted in the OCS Heart EXPAND and OCS Heart EXPAND CAP studies.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date August 2026
Est. primary completion date August 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• OCS Heart
Transplanted with OCS preserved heart.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
TransMedics

Outcome
Type Measure Description Time frame Safety issue
Other Cardiac patient survival Cardiac related patient survival through 5 years post-transplant 5 years post transplant
Other Graft survival Graft survival through 5 years post-transplant 5 years post transplant
Primary Patient survival Patient survival through 5 years post-transplant 5 years post transplant
See also
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