Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 4:38 AM
Study NCT ID:
NCT06497933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-19
First Post:
2024-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exhaustive French National Registry of AF Ablation Using Pentaspline Pulsed Field Ablation Catheter
Sponsor:
University Hospital, Rouen
Organization:
Study Overview
Official Title:
Exhaustive French National Online Registry of Atrial Fibrillation Ablation Procedures Using the Pentaspline Pulsed Field Ablation Catheter
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRANCE-PFA
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: