Exhaustive French National Registry of AF Ablation Using Pentaspline Pulsed Field Ablation Catheter

NCT ID: NCT06497933

Last Updated: 2024-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

5223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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This is a multicenter observational research project, that prospectively included patients undergoing a first time atrial fibrillation ablation using the Farapulse technology (Boston Scientific) since the start of this technology in France.

All patients treated with the Farapulse technology for atrial fibrillation in France from March 2021 to February 29th of 2024 will be included in the registry. The number of participating centers is 33.

A one-year and 2-year follow-up will be performed according to the standard practices of the different centers. The study duration will be 5 years.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Paroxysmal atrial fibrillation patients

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

Atrial fibrillation ablation

Intervention Type PROCEDURE

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

Persistent atrial fibrillation patients

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

Atrial fibrillation ablation

Intervention Type PROCEDURE

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

Long-standing persistent atrial fibrillation patients

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

Atrial fibrillation ablation

Intervention Type PROCEDURE

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

Interventions

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Atrial fibrillation ablation

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

Intervention Type PROCEDURE

Other Intervention Names

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Pulsed field ablation procedure using the Faradrive catheter (Boston Scientific)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previous left atrial ablation.
* Patient's opposition to participating in this registry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic ANSELME, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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University Hospital of Rouen

Rouen, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 40734736 (View on PubMed)

Other Identifiers

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2022/0259/OB

Identifier Type: -

Identifier Source: org_study_id

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