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New research · Pediatrics
Journal of the American College of Cardiology · 1d
StudyJournal of the American College of Cardiology · 2026

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

Jonathan B Edelson, Matthew J O'Connor, Muhammad Shezad … Angela Lorts
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PediatricsStudy

Pediatric ventricular assist device driver shows high 90-day survival.

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

Jonathan B Edelson et al. · Journal of the American College of Cardiology · 2026
Background

Pediatric patients with heart failure increasingly rely on ventricular assist devices as a bridge to transplantation.

Purpose

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.

n = 3 patients
98.1%
Results
most children were alive 90 days after getting the new heart pump
n = 3 patients
More 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.

More results

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

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

“
Conclusion · 1 of 2

This novel active driving system demonstrated excellent safety and reliability in a real-world, high-risk pediatric population, with no major device malfunctions.

Conclusion · 2 of 2

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.

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