OCS Heart EXPAND + CAP Continued Follow-Up | NCT05096299

Studies
OCS Heart EXPAND + CAP Continued Follow-Up

NCT05096299

Sponsor

TransMedics

Status

Active, not recruiting

Last Update Posted

Apr 9, 2025Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Heart Transplant

Interventions

OCS Heart

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 16, 2015Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

Oct 15, 2021

First Submission Date that Met QC Criteria

Oct 15, 2021

First Posted Date

Oct 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2025

Last Update Posted Date

Apr 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Name	Type	Description	Arm Group Labels	Other Names
OCS Heart	Device	Transplanted with OCS preserved heart.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient survival	Patient survival through 5 years post-transplant	5 years post transplant

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Cardiac patient survival	Cardiac related patient survival through 5 years post-transplant	5 years post transplant
Graft survival	Graft survival through 5 years post-transplant

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample