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The Effect of Pulsed-field and Radiofrequency Ablation on Platelet, Coagulation and Inflammation

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ClinicalTrials.gov Identifier: NCT05603637
Recruitment Status : Recruiting
First Posted : November 2, 2022
Last Update Posted : February 15, 2023
Sponsor:
Information provided by (Responsible Party):
Pavel Osmancik, Charles University, Czech Republic

Study Description
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Brief Summary:
The aim of the study is to compare platelet activation, activation of the coagulation and inflammation cascade during catheter ablation for atrial fibrillation using radiofrequency or pulsed-field energy. Patients with atrial fibrillation and standard indication for ablation according to the current guidelines will be randomized to ablation either using radiofrequency of pulsed-field energy. The endpoints will be parameters of platelet activation, activation of coagulation, and changes in inflammatory markers during ablation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Catheter ablation using SmartTouch radiofrequency ablation catheter Procedure: Catheter ablation using Farawave pulsed-field ablation catheter Not Applicable

Detailed Description:

Catheter ablation for atrial fibrillation (AF) , i.e. pulmonary vein isolation, is associated with the activation of platelets, coagulation cascade and inflammatory parameters. Thrombus in the left atrium could arise on sheaths or wires, but the highest risk presents the ablations itself. Radiofrequency ablation leads to immediate endocardial damage that presents strong pro-thrombotic milieu. To avoid thrombus formation on catheters in the left atrium, heparin with target activated clotting time (ACT) of 250-300 is given during the procedure.

Newly, pulsed - field ablation has been widely emerged. Since the pulsed-field energy presents substantially different kind of ablation energy, and the mechanism of action differs substantially (no thermal injury, no acute necrosis), also the effect on platelets, coagulation and inflammatory parameters could differ substantially.

The investigators therefore initiate a study comparing the effect of radiofrequency and pulsed-field ablation on parameters of platelet activation, coagulation and inflammation during catheter ablation.

Patients with AF indicated for catheter ablation according current guidelines will be randomized to radiofrequency or pulsed-field ablation. The procedure will be done using standard approach from one or both femoral veins under moderate analgesia. Using intracardiac echocardiography, and by means of SL1 sheath (Abbott, USA), transseptal puncture will be done. In patients in the radiofrequency arm, Lasso (circular mapping catheter) will be inserted in all four pulmonary veins, and using Smart Touch ablation catheter (Biosense Webster, USA), pulmonary vein isolation will be done with target ablation index of 400 on anterior and superior aspects of pulmonary veins and 350 of the posterior wall of the left atrium. In patients in the pulsed-field arm, SL1 sheath will be replaced by Faradrive sheath (Boston Scientific, USA), and pulmonary vein isolation will be done using Farawave catheter (Boston Scientific, USA).

Blood samples will be drawn at the beginning of the procedure from the right atrium (S1), after the transeptal puncture before the ablation from the left atrium (S2), after the ablation when all 4 pulmonary vein are isolated (S3), 24 hours after the procedure before patient discharge (S4), and 3 months after the procedure during follow-up.

Platelet activity will be determined using flow cytometry (membrane expression of P-selectin (CD62P) antigen, active part of the glycoprotein IIb/IIIa (PAC-1), CD 41/61 antigens). Changes in coagulation will be determined by measuring D-dimers and fibrin-monomers. Regarding the inflammatory parameters, plasma concentration of interleukin-6, and membrane activation antigens on leukocytes will be assessed using flow cytometry.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Effect of Pulsed-field and Radiofrequency Ablation for Atrial Fibrillation on Platelet Activity, Coagulation and Inflammation
Actual Study Start Date : November 1, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Radiofrequency ablation arm
Patients will undergo pulmonary vein isolation by means of radiofrequency energy. The ablation will be done using SmartTouch ablation catheter (Biosense Webster, USA).
 Procedure: Catheter ablation using SmartTouch radiofrequency ablation catheter
Patients will undergo catheter ablation for atrial fibrillation, i.e. pulmonary vein isolation, using radiofrequency energy with SmatTouch ablation catheter (Biosense Webster, USA)
Experimental: Pulsed- field ablation arm
Patients will undergo pulmonary vein isolation by means of pulsed-field ablation. The ablation will be done using Farawave ablation catheter (Boston Scientific, USA).
 Procedure: Catheter ablation using Farawave pulsed-field ablation catheter
Patients will undergo catheter ablation for atrial fibrillation, i.e. pulmonary vein isolation, using pulsed-field energy with Farawave ablation catheter (Boston Scientific, USA)


Outcome Measures
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Primary Outcome Measures :
  1. Membrane expression of CD62P [ Time Frame: 3 months ]
    Platelet activity determined by activation marker

  2. Membrane expression of PAC-1 [ Time Frame: 3 months ]
    Platelet activity determined by activation marker

  3. Concentration of D-dimers, fibrin-monomers,and voln Willebrand factor [ Time Frame: 3 months ]
    Changes in the coagulation cascade

  4. Concentration in interleukin-6 and membrane expression of leukocyte activation markers [ Time Frame: 3 months ]
    CHanges in parameters of inflammation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • atrial fibrillation - paroxysmal of persistent

Exclusion Criteria:

  • pregnancy
  • left atrium > 60 mm
  • mechanical valve
  • known prothrombotic state
  • rheumatic heart disease
  • severe valve disease (i.e. mitral insufficiency > 2, aortic stenosis)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05603637


Locations
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Czechia
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady Recruiting
Prague, Czechia, 10034
Contact: Pavel Osmancik, MD, PhD    00420 ext 721544447    pavel.osmancik@volny.cz   
Sponsors and Collaborators
Charles University, Czech Republic
More Information
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Responsible Party: Pavel Osmancik, head of the department of arrhythmias, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT05603637    
Other Study ID Numbers: PFA-RFA Thrombo
First Posted: November 2, 2022    Key Record Dates
Last Update Posted: February 15, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocol will be shared on demand
Supporting Materials: Study Protocol
Time Frame: After study initiation

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pavel Osmancik, Charles University, Czech Republic:
atrial fibrillation
catheter ablation
radiofrequency ablation
 pulsed-field ablation
platelet activity
coagulation
Additional relevant MeSH terms:
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Atrial Fibrillation
Inflammation
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes