Observational Study of the Clinical Use of the OCS™ Heart

Hannover Medical School (MHH)

Status: Completed

Conditions: Heart Transplantation

Treatments: Device: OCS Heart System

Study type: Observational

Funder types: Other

Identifiers

NCT03687723

OCS-Heart-2016

Details and patient eligibility

About

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™)

Full 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.

Enrollment: 93 patients

Sex: All

Volunteers: No Healthy Volunteers

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