NCT05096299

Brief Summary

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

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Sep 2015

Longer than P75 for all trials

Status
active not recruiting

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 Progress98%
Sep 2015Aug 2026

Study Start

First participant enrolled

September 16, 2015

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

10.9 years

First QC Date

October 15, 2021

Last Update Submit

April 8, 2025

Conditions

Heart Transplant

Outcome Measures

Primary Outcomes (1)

  • Patient survival

    Patient survival through 5 years post-transplant

    5 years post transplant

Other Outcomes (2)

  • Cardiac patient survival

    5 years post transplant

  • Graft survival

    5 years post transplant

Interventions

OCS HeartDEVICE

Transplanted with OCS preserved heart.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials will comprise the patient population for this PAS.

You may qualify if:

  • Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 27, 2021

Study Start

September 16, 2015

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 9, 2025

Record last verified: 2025-04