Computed Tomography of Pulse-Field Ablation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) reduces left atrial (LA) volume post-ablation, a phenomenon termed reverse atrial remodeling, indicative of successful reversal of atrial cardiomyopathy progression. In contrast, pulse field ablation (PFA), a novel non-thermal technology, offers a promising efficacy and safety profile without inducing persistent atrial fibrosis. While RFCA-associated reverse atrial remodeling is well-documented, it remains uncertain whether PFA, operating on a non-thermal paradigm, also promotes this remodeling, which would enhance its physiological relevance in AF treatment. Additionally, RFCA studies show that LA wall thickness at the pulmonary vein (PV) antrum can predict PV reconnection and arrhythmia recurrence, but whether PFA affects LA thinning or enables similar predictions from post-treatment computed tomography (CT) scans is unknown. Moreover, epicardial adipose tissue (EAT), strongly linked to LA abnormalities and AF recurrence, can be quantified via CT, yet the impact of PFA on LA EAT remains unexplored. Finally, PFA's versatility, particularly in isolating the LA posterior wall (LAPW) in non-paroxysmal AF, raises questions about its effect on posterior wall thinning or EAT changes, factors associated with post-ablation recurrence

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18 years at the time of AF ablation

AF ablation by pulse-field ablation (BOSTON SCIENTIFIC FARAPULSE) or by radiofrequency (any manufacturer) between 2020 and 2024

Paroxysmal or non-paroxysmal AF

Pre-ablation CT data available and of high quality

Disqualifiers

Low quality CT, non-homogeneous contrast agent perfusion

Post-ablation CT performed in another center

Patients in which pre- and post-ablation CTs do not share common phases

Patients who underwent ethanol infusion in the vein of Marshall

Trial population

All patients at Hôpital Pitié Salpêtrière meeting the study criteria

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Pulse-Field Ablation
Group B: Radiofrequency Catheter Ablation

Trial outcomes

Primary outcomes

1

Difference between baseline and post-ablation LA indexed volume (ml/cm^2)

Time frame
Post-procedural (3-months)

Secondary outcomes

1

Difference between baseline and post-ablation mean wall thickness, mm

Time frame
Post-procedural (3-months)
2

Difference between baseline and post-ablation Epicardial adipose tissue , mm^3

Time frame
Post-procedural (3-months)
3

Difference between baseline and post-ablation left atrial appendage indexed volume, ml/cm^2

Time frame
Post-procedural (3-months)
4

Difference between baseline and post-ablation left atrial appendage dimensions (long-axis, short-axis, ostium long-axis, ostium short-axis), mm

Time frame
Post-procedural (3-months)

Other outcomes

Sponsors and contacts

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Assistance Publique - Hôpitaux de Paris

Lead sponsor

Boston Scientific Corporation

Collaborator

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