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

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™)

Study Overview

• Status: Recruiting
• Conditions: Heart Transplantation
• Intervention / Treatment: Device: OCS Heart System

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Fabio Ius, Dr.; Phone Number: +49 511-532-2125; Email: Ius.Fabio@mh-hannover.de
• Study Contact Backup: Name: Susanne Freyt; Phone Number: +49 511-532-3450; Email: freyt.susanne@mh-hannover.de

Study Locations

• Germany
  • Hannover, Germany
    • Recruiting
    • Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery
    • Contact: Fabio Ius, Dr.; Phone Number: +49 511-532-2125; Email: Ius.Fabio@mh-hannover.de
    • Sub-Investigator: Tim Kaufeld, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients requiring heart transplantation who receive OCS™-preserved heart transplants.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Survival	12-month patient survival post heart transplant Primary Effectiveness Endpoint	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and Graft Survival	30-day patient and graft survival post heart transplant	30 days

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Fabio Ius, Dr., Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: OCS-Heart-2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes