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

Atrial Fibrillation Clinical Trial

Official title:

The Effect of Pulsed-field and Radiofrequency Ablation for Atrial Fibrillation on Platelet Activity, Coagulation and Inflammation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05603637
• Other study ID #: PFA-RFA Thrombo
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2023
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Inflammation

Intervention

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)
• 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)

Locations

Country	Name	City	State
Czechia	Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Membrane expression of CD62P	Platelet activity determined by activation marker	3 months
Primary	Membrane expression of PAC-1	Platelet activity determined by activation marker	3 months
Primary	Concentration of D-dimers, fibrin-monomers,and voln Willebrand factor	Changes in the coagulation cascade	3 months
Primary	Concentration in interleukin-6 and membrane expression of leukocyte activation markers	CHanges in parameters of inflammation	3 months