Actively Recruiting
Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pulsed-field Ablation
Led by Daniel Rodríguez Muñoz · Updated on 2025-09-11
96
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pulsed-field Ablation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Diagnosed with paroxysmal or persistent atrial fibrillation
- Clinical indication to undergo pulmonary vein isolation
You will not qualify if you...
- Prior pulmonary vein isolation or left atrial linear ablation
- Severe frailty or life expectancy less than 1 year
- Unwillingness or inability to provide informed consent
- Ablation at sites beyond pulmonary vein isolation or indication for additional electrophysiological study
- Contraindication or intolerance to heparin
- Presence of left atrial thrombus
- Congenital heart disease
- Pregnancy, ongoing or planned in the following 6 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
Research Team
D
Daniel Rodriguez, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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