Observational Study of the Clinical Use of the OCS™ Heart

Last updated: March 1, 2023
Sponsor: Hannover Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Transplantation

Treatment

N/A

Clinical Study ID

NCT03687723
OCS-Heart-2016
  • All Genders

Study 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™)

Eligibility Criteria

Inclusion

Inclusion Criteria: All recipients of heart transplantation with Use of the OCS™ Heart

Exclusion

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 >15mmHg of the recipient

Study Design

Total Participants: 100
Study Start date:
October 01, 2016
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

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

    Hannover,
    Germany

    Active - Recruiting

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