NCT03687723

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™)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

8.2 years

First QC Date

September 26, 2018

Last Update Submit

September 29, 2025

Conditions

Heart Transplantation

Outcome Measures

Primary Outcomes (1)

  • Patient Survival

    12-month patient survival post heart transplant Primary Effectiveness Endpoint

    12 months

Secondary Outcomes (1)

  • Patient and Graft Survival

    30 days

Interventions

OCS Heart SystemDEVICE

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hanover, Germany

Location

Study Officials

  • Fabio Ius, Dr.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2018

First Posted

September 27, 2018

Study Start

October 1, 2016

Primary Completion

December 1, 2024

Study Completion

September 1, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations

DE(1)