NCT05603637

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

September 10, 2022

Last Update Submit

February 14, 2023

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationcatheter ablationradiofrequency ablationpulsed-field ablationplatelet activitycoagulation

Outcome Measures

Primary Outcomes (4)

  • Membrane expression of CD62P

    Platelet activity determined by activation marker

    3 months

  • Membrane expression of PAC-1

    Platelet activity determined by activation marker

    3 months

  • Concentration of D-dimers, fibrin-monomers,and voln Willebrand factor

    Changes in the coagulation cascade

    3 months

  • Concentration in interleukin-6 and membrane expression of leukocyte activation markers

    CHanges in parameters of inflammation

    3 months

Study Arms (2)

Radiofrequency ablation arm

ACTIVE COMPARATOR

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

Pulsed- field ablation arm

EXPERIMENTAL

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

Interventions

Catheter ablation using SmartTouch radiofrequency ablation catheterPROCEDURE

Patients will undergo catheter ablation for atrial fibrillation, i.e. pulmonary vein isolation, using radiofrequency energy with SmatTouch ablation catheter (Biosense Webster, USA)

Radiofrequency ablation arm
Catheter ablation using Farawave pulsed-field ablation catheterPROCEDURE

Patients will undergo catheter ablation for atrial fibrillation, i.e. pulmonary vein isolation, using pulsed-field energy with Farawave ablation catheter (Boston Scientific, USA)

Pulsed- field ablation arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • atrial fibrillation - paroxysmal of persistent

You may not qualify if:

  • pregnancy
  • left atrium \> 60 mm
  • mechanical valve
  • known prothrombotic state
  • rheumatic heart disease
  • severe valve disease (i.e. mitral insufficiency \> 2, aortic stenosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

Related Publications (1)

  • Osmancik P, Bacova B, Hozman M, Pistkova J, Kunstatova V, Sochorova V, Waldauf P, Hassouna S, Karch J, Vesela J, Poviser L, Znojilova L, Filipcova V, Benesova K, Herman D. Myocardial Damage, Inflammation, Coagulation, and Platelet Activity During Catheter Ablation Using Radiofrequency and Pulsed-Field Energy. JACC Clin Electrophysiol. 2024 Mar;10(3):463-474. doi: 10.1016/j.jacep.2023.11.001. Epub 2023 Nov 6.

    PMID: 38085214DERIVED

MeSH Terms

Conditions

Atrial FibrillationThrombosis

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of the department of arrhythmias

Study Record Dates

First Submitted

September 10, 2022

First Posted

November 2, 2022

Study Start

November 1, 2022

Primary Completion

December 1, 2023

Study Completion

February 1, 2024

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Study protocol will be shared on demand

Shared Documents
STUDY PROTOCOL
Time Frame
After study initiation

Locations

CZ(1)