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Comparison of Fluoroscopy-only vs. Electroanatomic Mapping Strategies for Pulmonary Vein Isolation With Balloon-based Pulsed-field Ablation

RECRUITINGN/ASponsored by Daniel Rodríguez Muñoz
Actively Recruiting
PhaseN/A
SponsorDaniel Rodríguez Muñoz
Started2025-08-05
Est. completion2025-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07118046

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* ≥18 years old
* Diagnosed with paroxysmal or persistent AF
* Clinical indication to undergo PVI

Exclusion Criteria:

* 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

Conditions2

Atrial FibrillationHeart Disease

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