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

ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Clinic of Barcelona

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for first-time atrial fibrillation catheter ablation

Disqualifiers

age <18 years

long-standing persistent atrial fibrillation

prior left atrial ablation

pregnancy or lactation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulmonary vein isolation

    Procedure/Surgery

    Catheter ablation

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Pulsed Field AblationExperimental treatment 1 intervention
Group B: Cryoballoon AblationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

LGE-CMR-determined ablation lesion quality

Complete late gadolinium enhancement encircling both pulmonarz vein pairs, with discontinuations adding up to less than 10% of the total length of the circumference

Time frame
3 months post-ablation

Secondary outcomes

1

AF-free survival

Time frame
3, 6 and 12 months post-ablation
2

Arrhythmia-free survival

Freedom from atrial tachycardia, atrial flutter and AF

Time frame
3, 6 and 12 months post-ablation
3

Time to first AF recurrence

Time frame
12, 24 and 36 months
4

Progression from paroxysmal to persistent AF

Time frame
12, 24 and 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Clinic of Barcelona

Lead sponsor

Source ClinicalTrials.gov
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