Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

The Galvanize Registry is a prospective and retrospective data collection study tracking the real-world outcomes of patients who receive pulsed electric field (PEF) energy delivery using the Galvanize system. PEF is an emerging technology used in procedures such as cardiac ablation for irregular heart rhythms and tumor ablation, where precisely targeted electrical pulses destroy abnormal tissue without the heat damage associated with conventional ablation techniques. As a newer technology, its long-term safety and effectiveness profile is still being established. Any patient who has undergone or will undergo a PEF procedure using Galvanize technology and has a life expectancy of at least three months (for prospective enrollees) or has completed at least three months of post-procedure imaging (for retrospective enrollees) is eligible. There are no exclusion criteria beyond these basic requirements, making this a broadly inclusive registry. Post-market registries for medical devices like this serve a critical function: they capture what happens in the real world after a technology leaves the controlled conditions of clinical trials. As PEF ablation expands into more clinical settings and patient populations, this registry will provide the safety and efficacy data that regulators, payers, and clinicians need to understand when and for whom the technology works best.