Effect of Coseal at the time of durable left ventricular assist device implantation on orthotopic heart transplantation (ACTRN12625000599471)

Durable left ventricular assist device (LVAD) is a form of mechanical support used in patients with end-stage heart failure as a bridge to heart transplantation. The technical challenges in heart transplantation in patients with an LVAD are often associated with adhesions around the heart and great vessels. This can lead to an increase in the surgical time, use of blood products, and overall perioperative risk. Coseal is a commercially available product which forms a hydrogel that inhibits adhesion formation. This has been studied in many surgical procedures including cardiac surgery, but has not been thoroughly studied in this population. This study aims to investigate the effect of Coseal spray application at the time of LVAD implant on the adhesions that are encountered at the time of orthotopic heart transplantation (OHTx).

Trial phase

Phase 3

Trial participation type

This trial is for clinical research of something other than a drug or device.

Principal investigator

Mr Atsuo Doi

Key inclusion data

INCLUSION: All adult patients undergoing durable LVAD implant as a bridge to transplantation. EXCLUSION: Durable biventricular assist device (BiVAD) implant, pump infection patients.