Inflammatory Response Following " Pulsed Field Ablation " vs. Radiofrequency Ablation-2 (RIPAF-2)

Inflammatory Response Following " Pulsed Field Ablation " vs. Radiofrequency Ablation of Paroxysmal Atrial Fibrillation-2

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).

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Atrial Fibrillation; Catheter Ablation
• Intervention / Treatment: Device: Radiofrequency; Device: Pulsed electric field

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Pierre Jais, MD, PhD; Phone Number: +33 5 57 65 64 71; Email: pierre.jais@chu-bordeaux.fr

Study Locations

• France
  • Pessac, France, 33604
    • Recruiting
    • Hôpital Haut-Lévèque
    • Contact: Pierre JAÏS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation treated by catheter ablation

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patients with paroxysmal AF referred for first-time catheter ablation using PFA or RFA
• Non-opposition to participate

Exclusion Criteria:

• Age < 18 years
• Persons under judicial protection (guardianship, guardianship) or deprived of freedom
• Prior left atrial ablation
• Prior cardiac surgery comprising incision of the left atrium
• Prior myocardial infarction or stroke in the previous 30 days
• Acute or chronic inflammatory state: active smoking, auto-immune disease, active tumor disease, myocarditis
• Antiplatelet therapy (e.g. aspirine, clopidogrel) within the 7 last days
• Anti-inflammatory treatment (e.g. glucocorticoids, colchicine, cyclophosphamide, azathioprine, mycophenolic acid, antibodies) within the 7 last days

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radiofrequency; Patient with atrial fibrillation ablated per radiofrequency	Device: Radiofrequency; Patient with atrial fibrillation ablated per catheter using radiofrequency energy; Other Names: Catheter ablation per radiofrequency
Pulsed electric field; Patient with atrial fibrillation ablated per pulsed electric field	Device: Pulsed electric field; Patient with atrial fibrillation ablated per catheter using pulsed electric field; Other Names: Catheter ablation per pulsed electric field

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute thromboinflammatory response	Circulating platelet-monocyte complexes (PMC)	24 hours
Systemic inflammatory response (IL-6)	Changes in leukocyte count and circulating levels of IL-6	24 hours
Systemic inflammatory response (TNF-α)	Changes in leukocyte count and circulating levels of TNF-α	24 hours
Systemic inflammatory response (CRP)	Changes in leukocyte count and circulating levels of CRP	24 hours
Pericarditis	Chest pain suggestive of pericarditis assessed using a numeric pain rating scale (0 to 10)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of early arrhythmias	Incidence of early arrhythmias occurring during the post-operative period on telemetry in PFA vs. RFA	24 hours
Analysis of biomarkers (CD40L)	Platelet activation: Changes in plasma levels of soluble CD40L	24 hours
Analysis of biomarkers (Willebrand)	Endothelial cell damage: Changes in plasma levels of von Willebrand factor	24 hours
Incidence of late atrial arrhythmia recurrence	Atrial fibrillation and/or atrial tachycardia recurrences documented by Holter-ECGs or other wearable devices	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Director: Pierre JAÏS, MD, CHU Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): April 16, 2024
• Study Completion (Estimated): December 16, 2024

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Inflammation; Atrial Fibrillation; catheter ablation; Pulsed-field ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Inflammation; Atrial Fibrillation
• Other Study ID Numbers: CHUBX 2023/33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No