Comparing two ways to guide heart ablation for atrial fibrillation
Compares two guidance methods during balloon pulsed-field ablation in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pulsed-field Ablation
Key facts
- Where
- Madrid, SpainSee the site
Where in Spain
- University Hospital 12 de OctubreMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Daniel Rodríguez Muñoz
- Trial code
- NCT07118046
- Record updated
- 11 September 2025
- Original description
We designed a study to evaluate the impact of a two systematic strategies for PVI with the octaspline, balloon-based PFA (B-PFA) catheter. We hypothesized that the addition of electroanatomic guidance is non-superior to fluoroscopy-only guidance in achieving durable PVI.Read full original descriptionShow less
Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pulsed-field Ablation
We designed a study to evaluate the impact of a two systematic strategies for PVI with the octaspline, balloon-based PFA (B-PFA) catheter. We hypothesized that the addition of electroanatomic guidance is non-superior to fluoroscopy-only guidance in achieving durable PVI.
Inclusion: ≥18 years old; Diagnosed with paroxysmal or persistent AF; Clinical indication to undergo PVI.
Exclusion: Prior PVI or left atrial linear ablation; Congenital heart disease; Severe frailty or life expectancy <1 year; Unwillingness or inability to provide informed consent; Ablation at sites beyond PVI or indication for additional electrophysiological study; Contraindication or intolerance to heparin; Presence of left atrial thrombus; Pregnancy, ongoing or planned in the following 6 months.