Abstract

Background - Pulmonary vein isolation (PVI) is insufficient to treat all patients with persistent atrial fibrillation (AF), and effective adjunctive ablation strategies are needed. Ablation of AF drivers holds promise, but current technologies to identify drivers are limited by spatial resolution. In a single-arm, first-in-human, investigator-initiated FDA IDE study, we employed a novel system for real-time, high-resolution identification of AF drivers in persistent AF. Methods - Persistent or longstanding persistent AF patients underwent ablation using the RADAR system in conjunction with a standard electroanatomical mapping system. After PVI, electrogram and spatial information was streamed and analyzed to identify driver domains to target for ablation. Results - Across 4 centers, 64 subjects were enrolled: 73% male, age 64.7±9.5 years, BMI 31.7±6.0 kg/m2, LA size 54±10 mm, with persistent/longstanding persistent AF in 53 (83%) / 11 (17%), prior AF ablation (re-do group) in 26 (41%). After 12.6 ±} 0.8 months follow-up, 68% remained AF-free off all antiarrhythmics; 74% remained AF-free and 66% remained AF/AT/AFL-free on or off antiarrhythmic drugs. AF terminated with ablation in 35 patients (55%) overall and in 23/38 (61%) of de novo ablation patients. For patients with AF termination during ablation, 82% remained AF-free and 74% AF/AT/AFL free during follow-up on or off antiarrhythmic drugs. Patients undergoing first-time ablation generally had higher rates of freedom from AF than the re-do group. Conclusions - This novel technology for panoramic mapping of AF drivers showed promising results in a persistent/long-standing persistent AF population. These data provide the scientific basis for a randomized trial. Clinical Trial Registration - clinicaltrials.org; Unique Identifier: NCT03263702; IDE#G170049.

View details for DOI 10.1161/CIRCEP.119.007825

View details for PubMedID 31944826