Heart failure & cardiomyopathiesCohort study
Prospective Multicenter Evaluation of a Novel Active Driving System for Pediatric Ventricular Assist Device Support
- Prospective multicenter clinical trial
- multicentre
- single-arm
- investigational device exemption
- continued access protocol
Adverse events adjudicated by an independent Clinical Events Committee; DSMB oversight
Authors' conclusion
This novel active driving system demonstrated excellent safety and reliability in a real-world, high-risk pediatric population, with no major device malfunctions.
Study context
- Population
- Pediatric patients with HF supported with the Berlin Heart EXCOR Pediatric VAD using the EXCOR Active Driver
- Participants
- 40 vs 118
- Exposure
- Investigational device exemption vs Continued access protocol
- Investigational device exemptionn = 40
- Continued access protocoln = 118
- Outcome
- Major device malfunction, adverse events, and successful outcome (survival to transplantation, recovery, or continued support)
- Follow-up
- 90 days postimplantation
Main finding
As reported in the abstract
Major device malfunction, AEs and successful outcome (survival to transplantation, recovery or continued support)
| Group | Major device malfunction | Remained on support | Transplantation | Converted to another support modality | Explanted for recovery | Stroke | 90-day mortality |
|---|---|---|---|---|---|---|---|
| Investigational device exemption | 0 | 65% | 17.5% | 15.0% | 1 patient | 12.5% | 0% |
- Survival at 90 days, continued access protocol
- 98.1%
Observational data: associations, not effects.
Further findings
Status at data abstraction, continued access protocol · time of data abstraction
- Transplantation
- 37% (n = 44)
- Alive on device
- 31% (n = 37)
- Explanted for recovery
- 6% (n = 7)
- Converted to another support modality
- 23% (n = 27)
- Withdrawal of support
- 3 patients
Safety
| Outcome | Values |
|---|---|
| Stroke | IDE 12.5% |
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Prospective Multicenter Evaluation of a Novel Active Driving System for Pediatric Ventricular Assist Device Support. J Am Coll Cardiol. Published 6 May 2026. doi:10.1016/j.jacc.2026.03.080
Summarised from the published abstract; every number is checked against it