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NCT Number: NCT07395089

Computed Tomography of Pulse-Field Ablation

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pitié Salpêtrière

Paris, Île-de-France Region, 75013, France

Location contact

Mikael Laredo, MD, PhD

CONTACT

[email protected]

+33 1 42 16 30 81

Mikael Laredo, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Post-ablation CT data available and of high quality
  • Post-ablation CT performed 3-months (+- 2 weeks) after AF ablation

Exclusion criteria

  • 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

Treatment and study plan

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)

  5. Difference between baseline and post-ablation mean LA wall thickness at the LAPW, mm

    Time frame: Post-procedural (3-months)

  6. Difference between baseline and post-ablation epicardial adipose tissue at the PW, mm^3

    Time frame: Post-procedural (3-months)

  7. Recurrence of sustained atrial arrhythmia

    Time frame: Post-procedural (3-months)

  8. Recurrence of sustained atrial arrhythmia

    Time frame: 12 months after procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Mikael Laredo, MD, PhD

CONTACT

[email protected]

+33 1 42 16 30 81

Nadjia Kachenoura, PhD

CONTACT

+33 1 44 27 91 16

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: CT-PFA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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