OCS DCD Heart + CAP Continued Follow-Up
1 other identifier
observational
276
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 26, 2019
CompletedFirst Submitted
Initial submission to the registry
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
February 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
September 9, 2025
September 1, 2025
6.9 years
February 13, 2023
September 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Patient survival
Patient survival through 5 years post-transplant
5 years post-transplant
Other Outcomes (3)
Cardiac related patient survival
5 years post-transplant
Graft survival
5 years post-transplant
Patient and graft survival
5 years post-transplant
Interventions
Transplanted with OCS preserved heart.
Eligibility Criteria
Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP will comprise the patient population for this PAS.
You may qualify if:
- Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP trials.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TransMedicslead
Study Sites (20)
University of California San Diago
La Jolla, California, 92037, United States
Stanford University
Palo Alto, California, 94304, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northwestern Medicine
Chicago, Illinois, 60611, United States
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, 46260, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
University of Minnesota
Minneapolis, Minnesota, 55414, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Nyph/Cumc
New York, New York, 10032, United States
Montefiore
The Bronx, New York, 10467, United States
Duke University
Durham, North Carolina, 27710, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37232, United States
Sentara
Norfolk, Virginia, 23502, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2023
First Posted
February 23, 2023
Study Start
November 26, 2019
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
September 9, 2025
Record last verified: 2025-09