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Completed

NCT Number: NCT06160076

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Haut-Lévèque

Pessac, 33604, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency

Device

Patient with atrial fibrillation ablated per catheter using radiofrequency energy

Other names: Catheter ablation per radiofrequency

Pulsed electric field

Device

Patient with atrial fibrillation ablated per catheter using pulsed electric field

Other names: Catheter ablation per pulsed electric field

Primary outcomes

  1. Acute thromboinflammatory response

    Time frame: 24 hours

    Circulating platelet-monocyte complexes (PMC)

  2. Systemic inflammatory response (IL-6)

    Time frame: 24 hours

    Changes in leukocyte count and circulating levels of IL-6

  3. Systemic inflammatory response (TNF-α)

    Time frame: 24 hours

    Changes in leukocyte count and circulating levels of TNF-α

  4. Systemic inflammatory response (CRP)

    Time frame: 24 hours

    Changes in leukocyte count and circulating levels of CRP

  5. Pericarditis

    Time frame: 24 hours

    Chest pain suggestive of pericarditis assessed using a numeric pain rating scale (0 to 10)

Secondary outcomes

  1. Incidence of early arrhythmias

    Time frame: 24 hours

    Incidence of early arrhythmias occurring during the post-operative period on telemetry in PFA vs. RFA

  2. Analysis of biomarkers (CD40L)

    Time frame: 24 hours

    Platelet activation: Changes in plasma levels of soluble CD40L

  3. Analysis of biomarkers (Willebrand)

    Time frame: 24 hours

    Endothelial cell damage: Changes in plasma levels of von Willebrand factor

  4. Incidence of late atrial arrhythmia recurrence

    Time frame: 6 months

    Atrial fibrillation and/or atrial tachycardia recurrences documented by Holter-ECGs or other wearable devices

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: RIPAF-2

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 7, 2023
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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