The CONFIRM (Conventional ablation with or without FIRM (Focal impulse and rotor modulation)) study demonstrated that, by using a novel diagnostic mapping system, atrial fibrillation was acutely terminated or substantially slowed with less than 10 minutes of ablation per identified source. FIRM ablation also resulted in a 70% increase in the two-year freedom from atrial fibrillation (from 50% with standard-of-care ablation to 84% when preceded by FIRM). Follow-up was verified using implantable devices in the majority of FIRM patients. Rotors and/or focal sources were seen in 98% of study patients.
“The diagnostic mapping system used in this trial enabled, for the first time, the identification of sources causing atrial fibrillation in patients. These sources were then quickly and effectively eliminated with standard therapeutic tools, even in this largely persistent, hard-to-treat atrial fibrillation population,” stated the lead investigator of the trial, Sanjiv Narayan, University of California, San Diego and VA Medical Center. “These promising results suggest that the fundamental approach used to treat these atrial fibrillation patients’ needs to be reevaluated.”
CONFIRM enrolled 103 patients from ages 40 to 82 years old (67% persistent atrial fibrillation, 33% paroxysmal). Patients were divided into two groups: a FIRM-guided ablation group consisting of 32 patients who received FIRM ablation for less than ten minutes per rotor/focus followed by wide area circumferential ablation (WACA) for PV isolation, and a conventional ablation group consisting of 71 patients who received WACA alone. Narayan was sponsored to conduct CONFIRM by the National Institutes of Health (NIH). The diagnostic technology used in this study has been licensed to Topera, Inc.