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NCT05741723 Clinical Trial

OCS DCD Heart + CAP Continued Follow-Up

Heart Transplant Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05741723
Other study ID # OCS-HEART-03-PAS
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 26, 2019
Est. completion date October 2026

Study information
Verified date April 2024
Source TransMedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The objective of this post-approval study is to evaluate long-term outcomes of patients enrolled in the OCS DCD Heart and OCS DCD Heart CAP studies.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 276
Est. completion date October 2026
Est. primary completion date October 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP trials.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• OCS Heart
Transplanted with OCS preserved heart.

Locations
Country Name City State
United States Emory University Hospital Atlanta Georgia
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Montefiore Bronx New York
United States Northwestern Medicine Chicago Illinois
United States Duke University Durham North Carolina
United States St. Vincent Cardiovascular Research Institute Indianapolis Indiana
United States Mayo Clinic Florida Jacksonville Florida
United States University of California San Diago La Jolla California
United States University of Wisconsin Madison Wisconsin
United States Froedtert & the Medical College of Wisconsin Milwaukee Wisconsin
United States Minneapolis Heart Institute Minneapolis Minnesota
United States University of Minnesota Minneapolis Minnesota
United States Vanderbilt Medical Center Nashville Tennessee
United States Yale New Haven Hospital New Haven Connecticut
United States Nyph/Cumc New York New York
United States Sentara Norfolk Virginia
United States University of Nebraska Medical Center Omaha Nebraska
United States AdventHealth Orlando Orlando Florida
United States Stanford University Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Cardiac related 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
Other Patient and graft survival Patient and 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
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