Heart Transplantation
Conditions
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™)
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.
Interventions
DEVICEOCS 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.
Sponsors
Hannover Medical School
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Survival | 12 months | 12-month patient survival post heart transplant Primary Effectiveness Endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Graft Survival | 30 days | 30-day patient and graft survival post heart transplant |
Countries
Germany
Outcome results
None listed