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Recruiting NCT06220006

Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance

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Trial Parameters

Condition Atrial Fibrillation
Sponsor Hospital Clinic of Barcelona
Study Type INTERVENTIONAL
Phase N/A
Enrollment 104
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-01
Completion 2025-11-01
Interventions
Pulmonary vein isolation

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Brief Summary

This randomised study will compare pulsed field ablation and cryoballoon ablation with respect to ablation lesion quality as assessed by late gadolinium enhancement (LGE) cardiac magnetic resonance (CMR) at 3 months post-ablation. Patients scheduled for first-time AF ablation will be randomised in a 2:1 fashion to receive PVI-only, either by pulsed field ablation (Farapulse Pulsed Field Ablation System, Boston Scientific) or cryoballoon ablation (Medtronic Cryoballoon Ablation System).

Eligibility Criteria

Inclusion Criteria: * Patients scheduled for first-time atrial fibrillation catheter ablation Exclusion Criteria: * age \<18 years * long-standing persistent atrial fibrillation * prior left atrial ablation * pregnancy or lactation * reduced left ventricular ejection fraction * GFR \<30% * BMI \>35% * left atrial diameter \>55 mm * cardiac implantable electronic device

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