Observational Study of the Clinical Use of the OCS™ Heart
NCT ID: NCT03687723
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
93 participants
OBSERVATIONAL
2016-10-31
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Presence of coronary heart diseases
* acute myocardial infarction
* Presence of heart valve disease (Stenosis or Insufficiency \> first degree)
* Presence of left ventricular hypertrophy (septum and posterior wall thickness \>1.7 cm)
* State of shock of donor (MAP \<60 mmHg, CVP \>15, PCWP \>15 mmHg) with use of Dobutamine \>10 ug/kg/min and/or Norepinephrine \> 0.5 ug/kg/min or Epinephrine \> 0.2 ug/kg/min
* irreversible persistant pulmonary hypertrophy, defined as transpulmonary gradient \>15 mmHg of the recipient
ALL
No
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Principal Investigators
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Fabio Ius, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery
Hanover, , Germany
Countries
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Other Identifiers
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OCS-Heart-2016
Identifier Type: -
Identifier Source: org_study_id
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