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

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Catheter ablation using SmartTouch radiofrequency ablation catheter
Catheter ablation using Farawave pulsed-field ablation catheter
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter ablation, radiofrequency ablation, pulsed-field ablation, platelet activity, coagulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske VinohradyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiofrequency ablation arm

Pulsed- field ablation arm

Arm Description

Patients will undergo pulmonary vein isolation by means of radiofrequency energy. The ablation will be done using SmartTouch ablation catheter (Biosense Webster, USA).

Patients will undergo pulmonary vein isolation by means of pulsed-field ablation. The ablation will be done using Farawave ablation catheter (Boston Scientific, USA).

Outcomes

Primary Outcome Measures

Membrane expression of CD62P
Platelet activity determined by activation marker
Membrane expression of PAC-1
Platelet activity determined by activation marker
Concentration of D-dimers, fibrin-monomers,and voln Willebrand factor
Changes in the coagulation cascade
Concentration in interleukin-6 and membrane expression of leukocyte activation markers
CHanges in parameters of inflammation

Secondary Outcome Measures

Full Information

First Posted
September 10, 2022
Last Updated
February 14, 2023
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT05603637
Brief Title
The Effect of Pulsed-field and Radiofrequency Ablation on Platelet, Coagulation and Inflammation
Official Title
The Effect of Pulsed-field and Radiofrequency Ablation for Atrial Fibrillation on Platelet Activity, Coagulation and Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, catheter ablation, radiofrequency ablation, pulsed-field ablation, platelet activity, coagulation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency ablation arm
Arm Type
Active Comparator
Arm Description
Patients will undergo pulmonary vein isolation by means of radiofrequency energy. The ablation will be done using SmartTouch ablation catheter (Biosense Webster, USA).
Arm Title
Pulsed- field ablation arm
Arm Type
Experimental
Arm Description
Patients will undergo pulmonary vein isolation by means of pulsed-field ablation. The ablation will be done using Farawave ablation catheter (Boston Scientific, USA).
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation using SmartTouch radiofrequency ablation catheter
Intervention Description
Patients will undergo catheter ablation for atrial fibrillation, i.e. pulmonary vein isolation, using radiofrequency energy with SmatTouch ablation catheter (Biosense Webster, USA)
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation using Farawave pulsed-field ablation catheter
Intervention Description
Patients will undergo catheter ablation for atrial fibrillation, i.e. pulmonary vein isolation, using pulsed-field energy with Farawave ablation catheter (Boston Scientific, USA)
Primary Outcome Measure Information:
Title
Membrane expression of CD62P
Description
Platelet activity determined by activation marker
Time Frame
3 months
Title
Membrane expression of PAC-1
Description
Platelet activity determined by activation marker
Time Frame
3 months
Title
Concentration of D-dimers, fibrin-monomers,and voln Willebrand factor
Description
Changes in the coagulation cascade
Time Frame
3 months
Title
Concentration in interleukin-6 and membrane expression of leukocyte activation markers
Description
CHanges in parameters of inflammation
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Osmancik, MD, PhD
Phone
00420
Ext
721544447
Email
pavel.osmancik@volny.cz

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol will be shared on demand
IPD Sharing Time Frame
After study initiation

Learn more about this trial

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

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