Sponsor-Initiated OCS Heart Perfusion Registry

Purpose

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

Condition

  • Heart Transplant

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • N/A

Exclusion Criteria

  • N/A

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Other
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Kamila Drezek
617-724-2610
KDREZEK@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
TransMedics

Study Contact

Raicca Haqqi
9788090620
rhaqqi@transmedics.com

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.