RecruitingNot ApplicableNCT06220006
Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance
Sponsor
Hospital Clinic of Barcelona
Enrollment
104 participants
Start Date
Nov 1, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria1
- Patients scheduled for first-time atrial fibrillation catheter ablation
Exclusion Criteria9
- 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
Interventions
PROCEDUREPulmonary vein isolation
Catheter ablation
Locations(1)
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NCT06220006
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