Skip to main content
OpenTrials
Completed

NCT Number: NCT01361295

Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF)

Radiofrequency catheter ablation of atrial fibrillation (AF) induces a procoagulant state, which leads to an acute risk for symptomatic cerebral embolism (CE) of approximately 1%. The induction of a procoagulant state has been studied in pulmonary vein isolation (PVI) with a non-cooled tip catheter. The induction of a procoagulant state using a cooled-tip catheter has not been studied yet. Due to the avoidance of high endocardial temperatures, it can be expected that these procedures induce a lower level of procoagulation.

Recent studies showed an 11% incidence of CE on diffusion weighted (DW) MRI in patients undergoing cooled-tip catheter ablation of AF. In this study there will be used to different catheters, the cooled-tip catheter and the PVAC Gold catheter. Since the PVAC Gold catheter is equipped with non-cooled electrodes, the risk of endothelial scarring, local thrombosis and CE may be increased.

The goal of this study is to determine the effect of two different ablation catheters on the induction of a procoagulant state and the incidence of CE on DW-MRI in patients with AF undergoing PVI.

Our hypothesis is that patients with AF undergoing PVI using the PVAC gold catheter will show a higher rise in procoagulation and a higher incidence of CE on DW-MRI than patients with AF undergoing PVI with the cooled-tip catheter.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Heart Diseases Intracranial Embolism Intracranial Embolism and Thrombosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, South Holland, Netherlands

About this study

A total of 70 patients scheduled for a first ablation of paroxysmal AF will be included. Patients will be 1:1 randomized to PVI using the PVAC gold catheter or the cooled-tip catheter. A control group of 20 patients with AF but without undergoing ablation is included for neuropsychological testing.

Before the procedure, the procoagulant state will be assessed by measuring several markers of endothelial damage, activated coagulation, fibrinolysis and by measurement of fibrinogen and thrombin generation. Measurements will be repeated during and after the procedure.

Documentation of the formation of CE will be established by performing a DW-MRI before and after the ablation. The proportion of symptomatic CE will be quantified by neuropsychological tests and questionnaires.

Finally, transcranial doppler will be performed during the entire procedure to quantify the number and pattern of cerebral microembolic signals (MES).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • suffering from drug-refractory paroxysmal atrial fibrillation
  • scheduled for first ablation procedure

Exclusion criteria

  • contra-indications for DW-MRI
  • previous AF-ablation
  • minors
  • any patient unable to undergo neuropsychological testing due to mental retardation

Treatment and study plan

PVI with PVAC gold

Procedure

Pulmonary vein isolation using the Medtronic PVAC gold catheter

Other names: Medtronic AF solutions

PVI with Cooled-RF

Procedure

Pulmonary vein isolation using the Biosense Webster Navistar Thermocool catheter

Other names: CARTO3 system

Primary outcomes

  1. Cerebral embolism

    Time frame: Between 24 hours before the ablation and 24 hours after the ablation

    Cerebral embolism will be documented with diffusion weighted MRI of the brain before and after ablation.

Secondary outcomes

  1. Neuropsychological functioning

    Time frame: Between a week before the ablation until 3 months after the ablation

    A decrease in neuropsychological functioning will be assessed with a questionnaire before and after the procedure

  2. Rise in procoagulation

    Time frame: Between 24 hours before the ablation and 24 hours after the ablation

    The procoagulant state will be assessed before, during and after the procedure by measurement of markers of endothelial damage, markers of activated coagulation, markers of fibrinolysis and by measurement of APTT, PT-INR, fibrinogen and thrombin generation.

Sponsors and collaborators

Lead sponsor

Serge A. Trines

Other

Registry information

Official study title

The Occurrence of Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF) Using Two Different Ablation Catheters

Acronym: CE-AF

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 26, 2011
Registry last updated
Sep 2, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.