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NCT03687723 Clinical Trial

Observational Study of the Clinical Use of the OCS™ Heart

Heart Transplantation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03687723
Other study ID # OCS-Heart-2016
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2016
Est. completion date March 2025

Study information
Verified date March 2023
Source Hannover Medical School
Contact Fabio Ius, Dr.
Phone +49 511-532-2125
Email Ius.Fabio@mh-hannover.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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™)

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Germany Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery Hannover

Sponsors (1)
Lead Sponsor Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Survival 12-month patient survival post heart transplant Primary Effectiveness Endpoint 12 months
Secondary Patient and Graft Survival 30-day patient and graft survival post heart transplant 30 days
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