Computed Tomography of Pulse-Field Ablation

NCT07395089 | Not Yet Recruiting

• 1 other identifier: NIXXXXXHLJ
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation (AF); Arrhythmia

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Post-procedural (3-months)

Secondary Outcomes (8)

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

  Post-procedural (3-months)

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

  Post-procedural (3-months)

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

  Post-procedural (3-months)

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

  Post-procedural (3-months)

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

  Post-procedural (3-months)

Study Arms (2)

Pulse-Field Ablation

Radiofrequency Catheter Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients at Hôpital Pitié Salpêtrière meeting the study criteria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Hôpital Pitié Salpêtrière

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

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carine Paré

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Mikael Laredo, MD, PhD

CONTACT

+33 1 42 16 30 81; mikael.laredo@aphp.fr

Nadjia Kachenoura, PhD

CONTACT

+33 1 44 27 91 16

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: February 9, 2026
• Study Start: February 1, 2026
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2025-02

Locations

FR (1)