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

NCT06220006 · tracked via the Priya Life Science Spain tracker

Sponsor

Hospital Clinic of Barcelona

Phase

Not applicable

Started

2023-11-01

Last updated

2026-04-07

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Pulmonary vein isolation

Pulmonary vein isolation: Catheter ablation

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

LGE-CMR-determined ablation lesion quality — 3 months post-ablation
Complete late gadolinium enhancement encircling both pulmonarz vein pairs, with discontinuations adding up to less than 10% of the total length of the circumference

Trial sites (1)

Facility	City	Region	Status
Hospital Clinic, University of Barcelona	Barcelona	Catalonia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06220006 on ClinicalTrials.gov ↗ ← All trials in Spain