Heart Failure

EXCOR Pediatric VAD — Novel Active Driving System, Multicenter Prospective

JACC, May 2026Multicenter prospective IDE trial (40 patients) + continued access protocol (118 patients)Source: Full text (JACC login)DOI: 10.1016/j.jacc.2026.03.080PMID 42089850

Authors: EXCOR Active Driver investigators
Journal / date: JACC, May 2026
DOI / URL: 10.1016/j.jacc.2026.03.080 | PMID 42089850
Source basis: Full text (JACC login)
Study type: Multicenter prospective IDE trial (40 patients) + continued access protocol (118 patients)
Population: Pediatric advanced HF requiring durable VAD support; mean age 38.2 months IDE cohort, 55% CHD
Intervention: Berlin Heart EXCOR Pediatric with novel Active Driver (vs prior IKUS driver — improves mobility, battery life, physiological adaptability)
Primary endpoints:

Device malfunction: 0% in both cohorts
90-day survival: 100% (IDE), 98.1% (continued access)
At 90 days (IDE): 17.5% transplanted, 65% on support, 15% converted, 1 explanted for recovery
Stroke 12.5% (IDE cohort)

Why it matters (clinical takeaway):

Validates the Active Driver as a safe and reliable replacement for the older IKUS — directly affects the clinical conversation with families about mobility, school re-entry, and quality of life during bridge-to-transplant.
Excellent safety profile (no major device malfunctions) supports broader adoption at pediatric VAD centers.
Demonstrates use of registry infrastructure for class III device evaluation — model for future pediatric device trials.

Caveats / limitations: Single-arm, no comparator. Stroke rate (12.5%) is consistent with prior pediatric VAD data but remains a key counseling point.
Referenced trials pulled forward: None this pass.