Clinical Trial

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

Study acronym: PULSED-ICE-CMR
Recruiting
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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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-01-22; most recent amendment 2026-04-01.
Trial Details
NCT Number NCT06220006
Lead Sponsor Hospital Clinic of Barcelona
Conditions Atrial Fibrillation
Enrollment 104 participants
Start Date 2023-11-01
Primary Completion 2025-11-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-07