Observational Study of the Clinical Use of the OCS™ Heart
NCT03687723 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 93
Last updated 2025-10-01
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™)
Conditions
- Heart Transplantation
Interventions
- 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.
Sponsors & Collaborators
-
Hannover Medical School
lead OTHER
Principal Investigators
-
Fabio Ius, Dr. · Hannover Medical School
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2024-12-31
- Completion
- 2025-09-30
- FDA Device
- Yes
Countries
- Germany
Study Locations
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