None listed
Conditions
Brief summary
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. Coseal is a commercially available product which forms a hydrogel that inhibits adhesion formation. 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 OHTx.
Interventions
Intervention administered
- What it involves for participants; Coseal is a commercially available product which forms a hydrogel that inhibits adhesion formation that is applied during LVAD implantation. Participants will be randomised to treatment vs control group. Treatment group will receive coseal spray at the end of LVAD implantation vs control group will not. Both groups will then be assessed for adhesions at time of LVAD explant and heart transplantation. No other change in workup and fol
Intervention administered - What it involves for participants; Coseal is a commercially available product which forms a hydrogel that inhibits adhesion formation that is applied during LVAD implantation. Participants will be randomised to treatment vs control group. Treatment group will receive coseal spray at the end of LVAD implantation vs control group will not. Both groups will then be assessed for adhesions at time of LVAD explant and heart transplantation. No other change in workup and follow up between the two groups. - Frequency and duration of intervention: one spray application administered during LVAD implantation surgery. Dissolves within 30 days. - Mode of administration: Spray applicator - Who will be administering intervention: LVAD implanting cardiothoracic surgeon - Strategies to monitor adherence: N/A
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All adult patients undergoing durable LVAD implant as bridge to transplantation
Exclusion criteria
Durable biventricular assist device (BiVAD) implant Pump infection patients
Outcome results
None listed