OCS DCD Heart + CAP Continued Follow-Up

Active, not recruiting

• Conditions: Heart Transplant

• Registration Number: NCT05741723
• Lead Sponsor: TransMedics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-26
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP trials.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient survival	5 years post-transplant	Patient survival through 5 years post-transplant

Trial Locations

Locations (20)

University of California San Diago; 🇺🇸 La Jolla, California, United States

Sentara; 🇺🇸 Norfolk, Virginia, United States

Nyph/Cumc; 🇺🇸 New York, New York, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States

St. Vincent Cardiovascular Research Institute; 🇺🇸 Indianapolis, Indiana, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Minneapolis Heart Institute; 🇺🇸 Minneapolis, Minnesota, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Vanderbilt Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Froedtert & the Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Montefiore; 🇺🇸 Bronx, New York, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States