NCT03687723

Observational Study of the Clinical Use of the OCS™ Heart

Observational Study of the Clinical Use of the Organ Care System (OCS™) in Heart Transplantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Single-arm, prospective, multi-center observational study of the clinical use of the ex-vivo perfusion of the heart with the Organ Care System (OCS™)

Detailed description

This is an observational study at two centers that will enroll minimum of 60 heart transplant recipients transplanted with donor heart preserved using the OCS™ Heart System. All consented subjects who receive OCS™-preserved heart transplants will be approached for participation. The study will evaluate short and long-term effectiveness of the OCS™ Heart System for heart transplantation.

Conditions

• Heart Transplantation

Interventions

Type	Name	Description
DEVICE	OCS Heart System	The OCS™ Heart System is a portable organ perfusion and monitoring medical device intended to preserve donor hearts in a near physiologic and beating state prior to transplantation.

Timeline

• Start date: 2016-10-01
• Primary completion: 2024-12-01
• Completion: 2025-09-01
• First posted: 2018-09-27
• Last updated: 2025-10-01

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study