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

RECRUITINGN/ASponsored by Hospital Clinic of Barcelona
Actively Recruiting
PhaseN/A
SponsorHospital Clinic of Barcelona
Started2023-11-01
Est. completion2025-11-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06220006

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Atrial FibrillationHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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