Observational Study of the Clinical Use of the OCS™ Heart

Recruiting

• Conditions: Heart Transplantation

• Registration Number: NCT03687723
• Lead Sponsor: Hannover Medical School

Brief 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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Survival	12 months	12-month patient survival post heart transplant Primary Effectiveness Endpoint

Secondary Outcome Measures

Name	Time	Method
Patient and Graft Survival	30 days	30-day patient and graft survival post heart transplant

Trial Locations

Locations (1)

Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery; 🇩🇪 Hannover, Germany