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Clinical Trials in Spain / NCT07118046
Recruiting Not applicable

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

NCT07118046 · tracked via the Priya Life Science Spain tracker
Sponsor
Daniel Rodríguez Muñoz
Phase
Not applicable
Started
2025-08-05
Last updated
2025-09-11

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Pulmonary vein isolation

Pulmonary vein isolation: Pulsed field ablation for pulmonary vein isolation in atrial fibrillation ablation

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Durable PVI (per vein) — 30 days after index procedure
    proportion of pulmonary veins durably isolated (i.e.: more than 30 days after index procedure);
  • Durable PVI (per patient) — 30 days after index procedure
    proportion of patients with all pulmonary veins durably isolated (i.e.: more than 30 days after index procedure);

Trial sites (1)

FacilityCityRegionStatus
University Hospital 12 de Octubre Madrid Madrid Recruiting

More Daniel Rodríguez Muñoz trials in Spain

Heart Rate Regularization in Atrial Fibrilation and Heart Failure Recruiting

Other trials for the same condition

A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation Active, not recruiting
STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation Active, not recruiting
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF Recruiting
PulseSelect™ PFA Global Registry Recruiting
The Fourth Left Atrial Appendage Occlusion Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07118046 on ClinicalTrials.gov ↗ ← All trials in Spain