Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160076
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-09-28
Brief Title:
Inflammatory Response Following Pulsed Field Ablation vs Radiofrequency Ablation-2
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Inflammatory Response Following Pulsed Field Ablation vs Radiofrequency Ablation of Paroxysmal Atrial Fibrillation-2
Status:
RECRUITING
Status Verified Date:
2023-11
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:
RIPAF-2
Brief Summary:
Atrial fibrillation AF is the most common sustained cardiac arrhythmia Catheter ablation using pulmonary vein isolation PVI in an established treatment strategy for AF Pulsed Field Ablation PFA is a non-thermal ablation modality which has recently been introduced in clinical practice with the aim of improving PVI efficacy and safety The aim of this study is to analyse whether PFA generates a lower inflammatory reaction as compared to conventional radiofrequency ablation RFA
Detailed Description:
Pulmonary vein isolation represents the cornerstone of AF ablation PFA is a novel non-thermal cardiac ablation modality which is currently studied in clinical trials for the treatment of AF with promising efficacy and safety results PFA is reported to generate less collateral damage by inducing selective apoptosis of cardiomyocytes while other structures such as nerves vessels and oesophageal tissue remain spared PFA lesions show more organized and homogeneous fibrosis on histopathological study as compared to thermal lesions In a recent study conducted at Hôpital Haut-Lévêque PFA was associated with 20 less acute oedema on magnetic resonance imaging Therefore PFA may generate a reduced inflammatory reaction which could translate into lower early recurrence rates less post-procedural chest pain and improved clinical outcomes Data on the systemic inflammation generated by PFA and RFA is still lacking
The aim of this study is to analyse the inflammatory reaction after PFA and RFA in patients referred for first-time catheter ablation of paroxysmal AF For this purpose established biomarkers of systemic inflammation leucocytosis platelet-monocyte-complexes inflammatory cytokines will be determined in blood samples collected from patients treated with either PFA or RFA
The collection of blood samples will be exclusively performed during routine blood drawing at three time points at the beginning of the procedure to define baseline values at the end of the procedure to measure acute inflammation and the day following the procedure to define inflammation occurring within 24 hours Clinical signs of inflammation fever chest pain pericardial fluid and early arrhythmia recurrences will also be assessed the day after the ablation On a routine 6-month follow-up visit late arrhythmia recurrences will be registered In a secondary analysis the thrombogenic and pro-arrhythmogenic potential of both ablation modalities and the predictive value of inflammatory biomarkers for early and late recurrences will be assessed
The aim of this study is to analyse the inflammatory reaction after PFA and RFA in patients referred for first-time catheter ablation of paroxysmal AF For this purpose established biomarkers of systemic inflammation leucocytosis platelet-monocyte-complexes inflammatory cytokines will be determined in blood samples collected from patients treated with either PFA or RFA
The collection of blood samples will be exclusively performed during routine blood drawing at three time points at the beginning of the procedure to define baseline values at the end of the procedure to measure acute inflammation and the day following the procedure to define inflammation occurring within 24 hours Clinical signs of inflammation fever chest pain pericardial fluid and early arrhythmia recurrences will also be assessed the day after the ablation On a routine 6-month follow-up visit late arrhythmia recurrences will be registered In a secondary analysis the thrombogenic and pro-arrhythmogenic potential of both ablation modalities and the predictive value of inflammatory biomarkers for early and late recurrences will be assessed
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None