Computed Tomography of Pulse-Field Ablation | NCT07395089

Studies
Computed Tomography of Pulse-Field Ablation

NCT07395089

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Not yet recruiting

Last Update Posted

Feb 9, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Atrial Fibrillation (AF)
Arrhythmia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2026Estimated

Primary Completion Date

Feb 2026Estimated

Completion Date

Feb 2026Estimated

First Submitted Date

Nov 28, 2025

First Submission Date that Met QC Criteria

Feb 3, 2026

First Posted Date

Feb 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2026

Last Update Posted Date

Feb 9, 2026Actual

Name	Class
Boston Scientific Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference between baseline and post-ablation LA indexed volume (ml/cm^2)		Post-procedural (3-months)

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients at Hôpital Pitié Salpêtrière meeting the study criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Carine Paré	Assistance Publique - Hôpitaux de Paris	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Pitié Salpêtrière		Paris	Île-de-France Region	75013	France

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided