Arrhythmias & electrophysiologyResearch article
Visually Guided Pulsed Field Ablation for Durable Pulmonary Vein Isolation Chronic Remapping and Clinical Outcomes in the First-in-Human VISION AF Study
- single-arm study
- first-in-human
Authors' conclusion
Direct visualization of electrode-tissue contact was associated with efficient, safe and durable PVI with promising rhythm outcomes. (Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation [VISION AF]; NCT06828939).
Study context
- Population
- Patients with paroxysmal atrial fibrillation undergoing pulmonary vein isolation (PVI)patients treated by four operators · Phase A 33 · Phase B 17
- Participants
- 50 patients
- Comparison
- Phase A vs Phase B
- Phase An = 33
- Phase Bn = 17
Main finding
As reported in the abstract
PVI achieved
PVI achieved in patients
100%
Applications per vein
4.3 ± 1.0
Further findings
| Outcome | Phase A | Phase B |
|---|---|---|
| Transpired PVI time | 26 ± 10 minutes | 18 ± 4 minutes |
Fluoroscopy time
- Fluoroscopy time
- 4 ± 3 minutes (range: 0-12 minutes)
Durable PVI on invasive remapping · 81 ± 28 days
- PVs with durable PVI
- 99.4% of PVs (175 of 176)
- Patients with durable PVI
- 97.8% of patients (44 of 45)
Freedom from atrial arrhythmias · Six-month
- Freedom from atrial arrhythmias
- 91.5% (95% CI: 79.3%-96.8%)
Anesthesia
- Deep sedation
- 86%
- General anesthesia
- 14%
Safety
Serious device-related complications
- There were no serious device-related complications
Brain magnetic resonance imaging lesions (36 patients)
- SCEs (DWI+/FLAIR-)
- 5.6%
- SCLs (DWI+/FLAIR+)
- 0%
Original publication
Visually Guided Pulsed Field Ablation for Durable Pulmonary Vein Isolation Chronic Remapping and Clinical Outcomes in the First-in-Human VISION AF Study. JACC Clin Electrophysiol. Published 23 April 2026. doi:10.1016/j.jacep.2026.04.009
Summarised from the published abstract; every number is checked against it