Observational Study of the Clinical Use of the OCS™ Heart

Status Recruiting

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™)

Clinical Trial 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 Design

Related Conditions & MeSH terms

Heart Transplantation

Clinical Trial Details

NCT number	NCT03687723
Study type	Observational
Source	Hannover Medical School
Contact	Fabio Ius, Dr.
Phone	+49 511-532-2125
Email	Ius.Fabio@mh-hannover.de
Status	Recruiting
Phase
Start date	October 2016
Completion date	March 2025

View Details

See also
Status	Clinical Trial	Phase
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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
Withdrawn	`NCT00780377` - Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients	N/A
Withdrawn	`NCT00780637` - Brachial Artery t-PA Release in Heart Transplant Recipients	N/A
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	`NCT00572286` - Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study	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
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