Arrhythmias & electrophysiology
EsophAguS Deviation During RadiofrequencY Ablation of Atrial Fibrillation: The EASY AF Trial
- stopped early for efficacy
Authors' conclusion
The use of an esophageal deviating device resulted in a significant reduction in ablation-related esophageal lesions without any adverse events.
Study context
- Population
- Patients undergoing radiofrequency ablation of AFrandomised
- Participants
- 120 patients
- Comparison
- Esophageal deviation device + LET monitoring vs LET monitoring alone during AF ablation
- Primary endpoint
- Ablation injury to the esophageal mucosa (assessed by endoscopy)
Methodological detailsmulticentre, double-blind, FDA investigational device exemption trial
- Multicentre
- Double-blind
- FDA investigational device exemption trial
Primary result
As reported in the abstract
Esophageal mucosal ablation injury
P < 0.0001
Further findings
Esophageal lesions, multivariable analysis
- Randomization to deviating device: only feature associated with reduced esophageal lesions
- 0.13; 0.04-0.46; P = 0.001 (OR; 95% CI; P)
- Multivariable analysis
Lesion severity and number of ablation lesions per patient
- Significantly higher severity and greater number of lesions per patient in control
Esophageal lesions among control subjects, high power/short duration vs other RF techniques
- High power/short duration
- 31.8%
- Other RF techniques
- 37.2%
- No difference
- P = 0.79
Safety
- No adverse event assigned to the device
Original publication
EsophAguS Deviation During RadiofrequencY Ablation of Atrial Fibrillation: The EASY AF Trial. JACC Clin Electrophysiol. Published 25 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →