Observational Study of the Clinical Use of the OCS™ Heart

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™)

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Key information

Conditions

Heart Transplantation

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery

Hanover, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All recipients of heart transplantation with Use of the OCS™ Heart

Exclusion criteria

Donor Hearts

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

Treatment and study plan

OCS Heart System

Device

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.

Primary outcomes

Patient Survival

Time frame: 12 months

12-month patient survival post heart transplant Primary Effectiveness Endpoint

Secondary outcomes

Patient and Graft Survival

Time frame: 30 days

30-day patient and graft survival post heart transplant

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2024
Study completion: 2025
First posted: Sep 27, 2018
Registry last updated: Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed