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

Atrial Fibrillation Clinical Trial

— CE-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361295
• Other study ID #: CE-AF-002
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2020
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism
• Intracranial Embolism

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Serge A. Trines

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Bulava A, Slavík L, Fiala M, Heinc P, Skvarilova M, Lukl J, Krcová V, Indrák 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. — View Citation

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. — View Citation

Schrickel JW, Lickfett L, Lewalter T, Mittman-Braun E, Selbach S, Strach K, Nähle CP, Schwab JO, Linhart M, Andrié 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral embolism	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	Neuropsychological functioning	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
Secondary	Rise in procoagulation	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