Clinical Trials Logo
  1. Home
  2. Heart Transplantation
  3. NCT03687723
  4. Details
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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06035991 - First Clinical Evaluation of Heart Transplantation With Grafts Preserved Using an Ex-vivo Extended Perfusion System N/A
Recruiting NCT01927614 - Advanced Cardiac Imaging in Cardiac Allograft Vasculopathy N/A
Recruiting NCT01705015 - Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement N/A
Completed NCT01655563 - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation Phase 2
Completed NCT01028599 - Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients N/A
Completed NCT00531921 - Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival N/A
Terminated NCT00420537 - Shift to Everolimus (RAD) Kidney Sparing Study Phase 4
Enrolling by invitation NCT03292861 - The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients Phase 2
Recruiting NCT04924491 - Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children Phase 1/Phase 2
Recruiting NCT05270902 - Haemoadsorption During Heart Transplantation N/A
Completed NCT05289180 - Brachial Right Ventricle - Endomyocardial Biopsy
Completed NCT01091194 - Effect of Exercise After Heart Transplantation Phase 2
Completed NCT01182571 - Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients N/A
Terminated NCT00678002 - Quality of Life in Pediatric Transplant Patients
Withdrawn NCT00780377 - Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients N/A
Withdrawn NCT00780637 - Brachial Artery t-PA Release in Heart Transplant Recipients N/A
Terminated NCT00121784 - Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients Phase 4
Withdrawn NCT00572286 - Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study N/A
Completed NCT00690157 - Registry of Patients Referred for Heart Transplantation N/A
Completed NCT00123331 - Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation Phase 4