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

September 1, 2020 updated by: Serge A. Trines

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PVI with PVAC gold
Patient for pulmonal vein isolation using the PVAC Gold Catheter. Intervention.
Procedure: PVI with Cooled-RF
Pulmonary vein isolation using the Biosense Webster Navistar Thermocool catheter
Other Names:
  • CARTO3 system
ACTIVE_COMPARATOR: PVI with Cooled-RF
Patient for pulmonal vein isolation using the Cooled-RF catheter.
Procedure: PVI with PVAC gold
Pulmonary vein isolation using the Medtronic PVAC gold catheter
Other Names:
  • Medtronic AF solutions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Between 24 hours before the ablation and 24 hours after the ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Between a week before the ablation until 3 months after the ablation
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.
Between 24 hours before the ablation and 24 hours after the ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Serge A. Trines

Investigators

  • Principal Investigator: Serge A. Trines, MD, PhD, Cardiology, LUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

May 20, 2011

First Submitted That Met QC Criteria

May 25, 2011

First Posted (ESTIMATE)

May 26, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE-AF-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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