RecruitingNot ApplicableNCT07118046
Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pulsed-field Ablation
Sponsor
Daniel Rodríguez Muñoz
Enrollment
96 participants
Start Date
Aug 5, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- ≥18 years old
- Diagnosed with paroxysmal or persistent AF
- Clinical indication to undergo PVI
Exclusion Criteria8
- Prior PVI or left atrial linear ablation
- 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
- Congenital heart disease
- Pregnancy, ongoing or planned in the following 6 months
Interventions
DEVICEPulmonary vein isolation
Pulsed field ablation for pulmonary vein isolation in atrial fibrillation ablation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07118046
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