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

NCT ID: NCT06160076

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2025-04-25

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.

Conditions

Atrial Fibrillation; Catheter Ablation; Inflammation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Radiofrequency

Patient with atrial fibrillation ablated per radiofrequency

Radiofrequency

Intervention Type: DEVICE

Patient with atrial fibrillation ablated per catheter using radiofrequency energy

Pulsed electric field

Patient with atrial fibrillation ablated per pulsed electric field

Pulsed electric field

Intervention Type: DEVICE

Patient with atrial fibrillation ablated per catheter using pulsed electric field

Interventions

Radiofrequency

Patient with atrial fibrillation ablated per catheter using radiofrequency energy

Intervention Type: DEVICE

Pulsed electric field

Patient with atrial fibrillation ablated per catheter using pulsed electric field

Intervention Type: DEVICE

Other Intervention Names

Catheter ablation per radiofrequency; Catheter ablation per pulsed electric field

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre JAÏS, MD

Role: STUDY_DIRECTOR

University Hospital, Bordeaux

Locations

Hôpital Haut-Lévèque

Pessac, , France

Countries

France

Other Identifiers

CHUBX 2023/33

Identifier Type: -

Identifier Source: org_study_id