RecruitingNot Applicable

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

Spain104 participantsStarted 2023-11-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

LGE-CMR-determined ablation lesion quality

Timeframe: 3 months post-ablation

Trial details

NCT IDNCT06220006

SponsorHospital Clinic of Barcelona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-01

View on ClinicalTrials.gov More Atrial Fibrillation trials