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Observational Study of the Clinical Use of the OCS™ Heart | Clinical Trials | Clareo Health

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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

NCT03687723•Hannover Medical School

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (1)

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

Hanover, Germany

Key Dates

Start Date

October 1, 2016

Primary Completion Date

December 1, 2024

Completion Date

September 1, 2025

Last Updated

October 1, 2025

Enrollment

ACTUAL participants

Conditions

Heart Transplantation

Interventions

OCS Heart System

DEVICE

Multimodal Analysis of Endomyocardial Biopsies

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Heart TransplantationDilated Cardiomyopathy (DCM)+5 more

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RECRUITING

Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Observational Study of the Clinical Use of the OCS™ Heart

Inclusion Criteria

Exclusion Criteria

Multimodal Analysis of Endomyocardial Biopsies

Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation

Haemoadsorption During Heart Transplantation

Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation

Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure

The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients