Pulmonary Vein Isolation With Contact-Force-Sensing Large-Tip Focal Pulsed Field Ablation Catheter With 3D Mapping for Paroxysmal Atrial Fibrillation: Omny-IRE 12-month Results.

BACKGROUND

Omny-IRE (NCT05971693) evaluated safety and effectiveness of a large-tip focal, multielectrode, contact-force-sensing, pulsed field ablation, basket catheter with electroanatomic mapping integration.

OBJECTIVE

Report 12-month (M) study outcomes.

METHODS

Pulmonary vein isolation was performed using the OMNYPULSE platform. Patients underwent follow-up through 12M postablation visit with electrocardiography (preprocedure, predischarge, and at 1, 3, 6, and 12M), 24-hour Holter monitoring (3, 6, and 12M), and remote rhythm monitoring (weekly: 1-5M; monthly: 6-12M; and symptom-triggered recordings). The secondary effectiveness endpoint was 12M freedom from documented symptomatic/asymptomatic atrial arrhythmia (≥30 s) and acute procedural failure. Device/procedure-related serious adverse events (SAEs), quality-of-life assessed by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) scores, and healthcare-utilization (cardiovascular-hospitalizations and antiarrhythmic drug [AAD] use) were also evaluated.

RESULTS

Among 188 enrolled patients, 136 comprised the main-phase-cohort for safety and effectiveness evaluations. In this cohort, 12M freedom from symptomatic/asymptomatic atrial arrhythmia was 82.5% (90.1% using standard-of-care monitoring only). Clinical success, defined as freedom from documented symptomatic arrhythmia and acute procedural failure, was 89.9%, while single procedural success was 89.2%. Device/procedure-related SAEs occurred in 2.9% of main-phase patients. Mean overall AFEQT score improved by 25.5 points from baseline to 12M. Cardiovascular-hospitalizations decreased by 40.9% versus the 12M preprocedure period, and Class I/III AAD use decreased by 49.3% 6-12M postablation versus baseline.

CONCLUSIONS

Omny-IRE results demonstrated the effectiveness, safety, and healthcare benefits of PFA with the OMNYPULSE platform.