Fluoroscopy-only versus electroanatomic mapping for pulmonary vein isolation using a balloon pulsed-field ablation catheter

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized study will enroll 96 consecutive adults with paroxysmal or persistent atrial fibrillation undergoing first-time pulmonary vein isolation with an octaspline balloon-based pulsed-field ablation catheter. After a 10-case run-in per operator, patients are randomized 1:1 to either a fluoroscopy-only workflow or the same fluoroscopy workflow with added electroanatomic mapping. Procedures are performed under deep sedo-analgesia and every patient undergoes systematic invasive remapping of the left atrium and pulmonary veins at least 30 days after the index ablation. The trial is conducted at University Hospital 12 de Octubre in Madrid with IRB approval and GDPR-compliant data handling.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital 12 de Octubre
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Daniel Rodriguez, MD PhD — University Hospital 12 de Octubre
• Study coordinator: Daniel Rodriguez, MD, PhD
• Email: daniel.rodriguez.mnz@gmail.com
• Phone: +34917792456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.