Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF)
NCT ID: NCT01361295
Last Updated: 2020-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2015-03-31
2017-12-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PVI with PVAC gold
Patient for pulmonal vein isolation using the PVAC Gold Catheter. Intervention.
PVI with Cooled-RF
Pulmonary vein isolation using the Biosense Webster Navistar Thermocool catheter
PVI with Cooled-RF
Patient for pulmonal vein isolation using the Cooled-RF catheter.
PVI with PVAC gold
Pulmonary vein isolation using the Medtronic PVAC gold catheter
Interventions
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PVI with PVAC gold
Pulmonary vein isolation using the Medtronic PVAC gold catheter
PVI with Cooled-RF
Pulmonary vein isolation using the Biosense Webster Navistar Thermocool catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* scheduled for first ablation procedure
Exclusion Criteria
* previous AF-ablation
* minors
* any patient unable to undergo neuropsychological testing due to mental retardation
18 Years
ALL
No
Sponsors
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Serge A. Trines
OTHER
Responsible Party
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Serge A. Trines
Senior cardiologist
Principal Investigators
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Serge A. Trines, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cardiology, LUMC
Locations
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Leiden University Medical Center
Leiden, South Holland, Netherlands
Countries
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References
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Sauren LD, VAN Belle Y, DE Roy L, Pison L, LA Meir M, VAN DER Veen FH, Crijns HJ, Jordaens L, Mess WH, Maessen JG. Transcranial measurement of cerebral microembolic signals during endocardial pulmonary vein isolation: comparison of three different ablation techniques. J Cardiovasc Electrophysiol. 2009 Oct;20(10):1102-7. doi: 10.1111/j.1540-8167.2009.01509.x. Epub 2009 Jun 22.
Schrickel JW, Lickfett L, Lewalter T, Mittman-Braun E, Selbach S, Strach K, Nahle CP, Schwab JO, Linhart M, Andrie R, Nickenig G, Sommer T. Incidence and predictors of silent cerebral embolism during pulmonary vein catheter ablation for atrial fibrillation. Europace. 2010 Jan;12(1):52-7. doi: 10.1093/europace/eup350.
Bulava A, Slavik L, Fiala M, Heinc P, Skvarilova M, Lukl J, Krcova V, Indrak K. Endothelial damage and activation of the hemostatic system during radiofrequency catheter isolation of pulmonary veins. J Interv Card Electrophysiol. 2004 Jun;10(3):271-9. doi: 10.1023/B:JICE.0000026924.96281.be.
Kece F, Bruggemans EF, de Riva M, Alizadeh Dehnavi R, Wijnmaalen AP, Meulman TJ, Brugman JA, Rooijmans AM, van Buchem MA, Middelkoop HA, Eikenboom J, Schalij MJ, Zeppenfeld K, Trines SA. Incidence and Clinical Significance of Cerebral Embolism During Atrial Fibrillation Ablation With Duty-Cycled Phased-Radiofrequency Versus Cooled-Radiofrequency: A Randomized Controlled Trial. JACC Clin Electrophysiol. 2019 Mar;5(3):318-326. doi: 10.1016/j.jacep.2018.11.008. Epub 2018 Dec 26.
Other Identifiers
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CE-AF-002
Identifier Type: -
Identifier Source: org_study_id
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