OCS Heart EXPAND + CAP Continued Follow-Up

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials

Treatment and study plan

OCS Heart

Device

Transplanted with OCS preserved heart.

Primary outcomes

Patient survival

Time frame: 5 years post transplant

Patient survival through 5 years post-transplant

Other outcomes

Cardiac patient survival

Time frame: 5 years post transplant

Cardiac related patient survival through 5 years post-transplant
Graft survival

Time frame: 5 years post transplant

Graft survival through 5 years post-transplant

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2026
Study completion: 2026
First posted: Oct 27, 2021
Registry last updated: Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting