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RADAR: A multicenter Food and Drug Administration Investigational Device Exemption clinical trial of persistent atrial fibrillation

Circulation: Arrhythmia and Electrophysiology Jan 24, 2020

Choudry S, Mansour M, Sundaram S, et al. - Researchers applied a new system for real-time, high-resolution identification of atrial fibrillation (AF) drivers in persistent AF in this single-arm, first-in-human, investigator-initiated Food and Drug Administration Investigational Device Exemption study. Ablation was performed using the RADAR (Real-Time Electrogram Analysis for Drivers of Atrial Fibrillation) system in conjunction with a standard electroanatomical mapping system in patients suffering from persistent or long-standing persistent AF. Following pulmonary vein isolation, electrogram and spatial information was streamed to the RADAR system and examined to recognize driver domains to target for ablation. A follow-up of 12.6 ± 0.8 months was performed. Findings revealed that 68%, 74%, and 66% remained AF-free off all antiarrhythmics, remained AF-free, and continued to be AF/atrial tachycardia/atrial flutter-free on or off AADs (antiarrhythmic drugs), respectively. AF termination consequent to ablation was noted in 35 patients (55%) overall and in 23/38 (61%) of de novo ablation patients. Higher rates of freedom from AF were generally reported in patients undergoing first-time ablation vs re-do group. Overall, promising outcomes were demonstrated by this new technology for the panoramic mapping of AF drivers, in a persistent/long-standing persistent AF population.
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