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Computed Tomography of Pulse-Field Ablation

Atrial Remodeling Associated With Pulse-Field Ablation of Atrial Fibrillation: a Computed Tomography Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07395089
Acronym
CT-PFA
Enrollment
90
Registered
2026-02-09
Start date
2026-04-15
Completion date
2026-06-30
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Atrial Fibrillation (AF)

Keywords

Ablation, Reverse Atrial Remodeling, Radiofrequency Catheter Ablation, Pulse Field Ablation, Pulmonary Vein Reconnexion, Epicardial Adipose Tissue

Brief summary

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

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
Boston Scientific Corporation
CollaboratorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age≥18 years at the time of AF ablation 2. AF ablation by pulse-field ablation (BOSTON SCIENTIFIC FARAPULSE) or by radiofrequency (any manufacturer) between 2020 and 2024 3. Paroxysmal or non-paroxysmal AF 4. Pre-ablation CT data available and of high quality 5. Post-ablation CT data available and of high quality 6. Post-ablation CT performed 3-months (+- 2 weeks) after AF ablation

Exclusion criteria

1. Low quality CT, non-homogeneous contrast agent perfusion 2. Post-ablation CT performed in another center 3. Patients in which pre- and post-ablation CTs do not share common phases 4. Patients who underwent ethanol infusion in the vein of Marshall

Design outcomes

Primary

MeasureTime frame
Difference between baseline and post-ablation LA indexed volume (ml/cm^2)Post-procedural (3-months)

Secondary

MeasureTime frame
Difference between baseline and post-ablation mean wall thickness, mmPost-procedural (3-months)
Difference between baseline and post-ablation Epicardial adipose tissue , mm^3Post-procedural (3-months)
Difference between baseline and post-ablation left atrial appendage indexed volume, ml/cm^2Post-procedural (3-months)
Difference between baseline and post-ablation left atrial appendage dimensions (long-axis, short-axis, ostium long-axis, ostium short-axis), mmPost-procedural (3-months)
Difference between baseline and post-ablation mean LA wall thickness at the LAPW, mmPost-procedural (3-months)
Difference between baseline and post-ablation epicardial adipose tissue at the PW, mm^3Post-procedural (3-months)
Recurrence of sustained atrial arrhythmiaPost-procedural (3-months)

Countries

France

Contacts

STUDY_DIRECTORCarine Paré

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026