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

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods used to guide heart ablation procedures for atrial fibrillation (AFib) — an irregular heart rhythm. One method uses traditional X-ray (fluoroscopy) guidance, and the other uses a 3D electrical mapping system. The goal is to see if the X-ray-only approach is just as safe and effective, which could reduce cost and complexity. **You may be eligible if...** - You are 18 or older - You have been diagnosed with paroxysmal (comes and goes) or persistent atrial fibrillation - Your doctor has recommended a pulmonary vein isolation (PVI) ablation procedure **You may NOT be eligible if...** - You have had a previous PVI or left atrial ablation procedure - You have severe frailty or a life expectancy under 1 year - You have a clot (thrombus) in the left atrium - You are allergic to heparin (a blood thinner used during the procedure) - You have congenital heart disease - You are pregnant or planning to become pregnant in the next 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPulmonary vein isolation

Pulsed field ablation for pulmonary vein isolation in atrial fibrillation ablation


Locations(1)

University Hospital 12 de Octubre

Madrid, Madrid, Spain

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NCT07118046


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