Abstract
This post-market clinical follow-up (PMCF) study evaluates the clinical effectiveness and safety of the external radio electric reprogramming for atrial fibrillation (EX-RER AF) protocol, a non-invasive regenerative medicine approach utilizing radio electric asymmetric conveyer (REAC) technology for managing paroxysmal atrial fibrillation (PAF). Administered with the REAC BENE mod 110 device (ASMED, Scandicci, Italy), the treatment involves a standardized procedure, with the asymmetric conveyor probe (ACP) positioned in the precordial area and fixed, unmodifiable parameters ensuring consistency and reproducibility. During a 36-month post-market clinical follow-up (PMCF), 20 patients with prior diagnoses of PAF underwent the protocol. Significant reductions in symptom severity were observed, with the European Heart Rhythm Association (EHRA) score improving from 3.1 ± 0.4 to 1.8 ± 0.3 (p < 0.01). The quality of life (QoL), as assessed using the Short Form 36-item health survey (SF-36), demonstrated a mean score increase from 58 ± 7 to 78 ± 6 (p < 0.01) across all domains. The safety profile of the protocol was reinforced, with no adverse events reported during the follow-up period. The observed improvements align with the established mechanism of action of REAC technology, which optimizes endogenous bioelectrical activity and promotes the functional reorganization of cardiac conduction pathways. While these findings underscore the protocol's safety, effectiveness, and clinical utility as a non-invasive therapeutic option for PAF, further studies in larger, diverse populations and comparative trials with conventional treatments are warranted to validate long-term outcomes and broader applicability.
Published Version
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