Prospective Multicenter Evaluation of a Novel Active Driving System for Pediatric Ventricular Assist Device Support.

Among 40 investigational device exemption patients (mean age: 38.2 months; 55% with congenital heart disease), there were no episodes of major device malfunction.

At 90 days, 65% remained on support, 17.5% had undergone transplantation, 15.0% were converted to another support modality, and 1 patient was explanted for recovery.

Stroke incidence was 12.5%, and 90-day mortality rate was 0%.

Among 118 continued access protocol patients, there were no major device malfunctions.