Arrhythmias & electrophysiology
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
Authors' conclusion
Omny-IRE results demonstrated the effectiveness, safety, and healthcare benefits of PFA with the OMNYPULSE platform.
Study context
- Population
- Patients with paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the OMNYPULSE platformenrolled, 136 comprised the main-phase-cohort for safety and effectiveness evaluations · main-phase-cohort 136
- Participants
- 188 patients
- Outcome
- Clinical success (freedom from documented symptomatic arrhythmia and acute procedural failure)
Methodological detailsdesign not otherwise stated, contact-force-sensing large-tip focal pulsed field ablation catheter with electroanatomic mapping integration, 12-month follow-up
- Design not otherwise stated
- Contact-force-sensing large-tip focal pulsed field ablation catheter with electroanatomic mapping integration
- 12-month follow-up
Main finding
As reported in the abstract
OMNYPULSE
89.9%
Further findings
| Outcome | Values |
|---|---|
| Single procedural success | OMNYPULSE 89.2% |
| Freedom from symptomatic/asymptomatic atrial arrhythmia (secondary effectiveness endpoint) · 12MMain-phase-cohort | OMNYPULSE 82.5% |
- Freedom from symptomatic/asymptomatic atrial arrhythmia (secondary effectiveness endpoint) — Using standard-of-care monitoring only
- 90.1%
Mean overall AFEQT score · baseline to 12M
- Improvement from baseline
- 25.5 points
Cardiovascular-hospitalizations · versus the 12M preprocedure period
- Decrease
- 40.9%
Class I/III AAD use · 6-12M postablation versus baseline
- Decrease
- 49.3%
Safety
| Outcome | Values |
|---|---|
| Device/procedure-related SAEsMain-phase patients | OMNYPULSE 2.9% |
Original publication
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. Heart Rhythm. Published 22 October 2026. doi:10.
Summarised from the published abstract; every number is checked against it