OHP-II: Sponsor-Initiated OCS Heart Perfusion Registry

Sponsor

TransMedics (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05915299

Collaborator

(none)

5,000

Enrollment

120

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

OHP-II Registry is a sponsor-initiated, multi-center, observational post-approval registry.

Condition or Disease	Intervention/Treatment	Phase
Heart Transplant	Device: OCS Heart

Detailed Description

The objective of this sponsor-initiated OHP-II Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and document the performance of the OCS device in the real-world setting.

All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry. Up to 5,000 subjects will be enrolled.

All interested U.S. Heart transplant centers that use the OCS Heart System for donor heart perfusion will constitute the OHP-II Registry participating centers.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Sponsor-Initiated OCS Heart Perfusion (OHP-II) Registry

Anticipated Study Start Date :

Aug 31, 2023

Anticipated Primary Completion Date :

Aug 31, 2029

Anticipated Study Completion Date :

Aug 31, 2033

Arms and Interventions

Arm	Intervention/Treatment
OCS Heart Transplant Recipients All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry. Up to 5,000 subjects will be enrolled.	Device: OCS Heart The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.

Arm

Intervention/Treatment

OCS Heart Transplant Recipients

All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry. Up to 5,000 subjects will be enrolled.

Device: OCS Heart

The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.

Outcome Measures

Primary Outcome Measures

Patient survival [One year post-heart transplant]
Patient survival at one-year post-heart transplant.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

TransMedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

TransMedics

ClinicalTrials.gov Identifier:

NCT05915299

Other Study ID Numbers:

OCS-HEART-OHP-II

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Jun 22, 2023