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

BACKGROUND: Pediatric patients with heart failure increasingly rely on ventricular assist devices as a bridge to transplantation. The Berlin Heart EXCOR Pediatric is the only durable ventricular assist device specifically approved for infants and small children, but its IKUS driver limits mobility and quality of life. The EXCOR Active Driver was developed to address these limitations by improving mobility, battery life, and physiological adaptability. OBJECTIVES: This prospective, multicenter clinical trial evaluated the performance, safety, and clinical outcomes of a novel driving system in pediatric patients. METHODS: Forty subjects were enrolled under a U.S. Food and Drug Administration-approved investigational device exemption, followed by 118 additional patients under a continued access protocol. Primary endpoints included the incidence of major device malfunction, adverse events, and successful outcomes-defined as survival to transplantation, recovery, or continued support at 90 days postimplantation. Adjudication of adverse events was conducted by an independent Clinical Events Committee, with oversight provided by a Data Safety Monitoring Board. Outcomes were assessed using descriptive statistics and competing risk models. RESULTS: 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. At the time of data abstraction, 37% (n = 44) had undergone transplantation, 31% (n = 37) were alive on device, 6% (n = 7) had the device explanted for recovery, 23% (n = 27) had been converted to another support modality, and 3 patients had withdrawal of support. Survival at 90 days was 98.1%. CONCLUSIONS: This novel active driving system demonstrated excellent safety and reliability in a real-world, high-risk pediatric population, with no major device malfunctions. This trial also validates the feasibility of leveraging a clinical registry infrastructure for class III device evaluation, offering a scalable and cost-efficient model for device approvals.