NCT06497933

Brief Summary

Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. This new ablation modality could increase the safety of pulmonary vein isolation (PVI) procedures compared to PVI using thermal energies. The investigators aim to provide the first exhaustive Nationwide registry using the pentaspline PFA catheter to treat atrial fibrillation patients.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

July 4, 2024

Last Update Submit

July 17, 2024

Conditions

Atrial Fibrillation

Keywords

Pulsed field ablationregistry

Outcome Measures

Primary Outcomes (2)

  • long-term efficacy (AA)

    freedom from all types of atrial arrhythmia recurrences

    within 1-year period post-procedure

  • very long-term efficacy (AA)

    freedom from all types of atrial arrhythmia recurrences

    Within 2 years period post-procedure

Secondary Outcomes (3)

  • long term efficacy (AF)

    within 1-year period post-procedure

  • very long-term efficacy (AF)

    Within 2 years period post-procedure

  • Safety outcomes

    within 1-month post-procedure

Study Arms (3)

Paroxysmal atrial fibrillation patients

patients with paroxysmal atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter

Procedure: Atrial fibrillation ablation

Persistent atrial fibrillation patients

patients with persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter

Procedure: Atrial fibrillation ablation

Long-standing persistent atrial fibrillation patients

patients with long-standing persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter

Procedure: Atrial fibrillation ablation

Interventions

Atrial fibrillation ablationPROCEDURE

Pulmonary veins isolation potentially associated with other atrial lesions, performed with the pentaspline PFA catheter

Also known as: Pulsed field ablation procedure using the Faradrive catheter (Boston Scientific)
Long-standing persistent atrial fibrillation patientsParoxysmal atrial fibrillation patientsPersistent atrial fibrillation patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent for the first time an atrial fibrillation ablation procedure, with pulmonary veins isolation performed with the pentaspline PFA catheter in France will be included in the registry

You may qualify if:

  • Patients aged ≥18 years
  • Patients who received catheter ablation for paroxysmal AF, persistent AF, or long-standing persistent AF.

You may not qualify if:

  • Previous left atrial ablation.
  • Patient's opposition to participating in this registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Rouen

Rouen, 76000, France

Location

Related Publications (1)

  • Chaumont C, Laredo M, Thomas O, Maury P, Massoulie G, Defaye P, Boveda S, Marijon E, Escande W, Roux A, Raczka F, Guyomar Y, Jais P, Ollitrault P, Granier M, Fareh S, Marchand H, Pierre B, Abbey S, Noel A, Da Costa A, Extramiana F, Cesari O, Champ-Rigot L, Khoueiry Z, Villemin T, Traulle S, Treguer F, Bader H, Deharo JC, Degand B, Guy-Moyat B, Klug D, Gandjbakhch E, Zhao A, Beneyto M, Eschalier R, Venier S, Combes S, Lepillier A, Mielczarek M, Clementy N, Menet A, Sacher F, De Chillou C, Anselme F. Countrywide introduction of pulsed field ablation for the treatment of atrial fibrillation: Acute results from the FRANCE-PFA registry. Heart Rhythm O2. 2025 Apr 25;6(7):911-919. doi: 10.1016/j.hroo.2025.04.005. eCollection 2025 Jul.

    PMID: 40734736DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frederic ANSELME, MD, PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2024

First Posted

July 12, 2024

Study Start

March 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2026

Last Updated

July 19, 2024

Record last verified: 2024-07

Locations

FR(1)