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

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT06220006

Run by

Hospital Clinic of Barcelona

People needed

104

Starts

2023-11-01

Expected to finish

2026-11-01

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients scheduled for first-time atrial fibrillation catheter ablation

You may not qualify if…

• 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

Where it is running

• Hospital Clinic, University of Barcelona — Barcelona, Catalonia, Spain (enrolling)

Full record on ClinicalTrials.gov

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