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

NCT01361295 | Completed DMC

• 1 other identifier: CE-AF-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; cerebral embolism; catheter ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Neuropsychological functioning

  Between a week before the ablation until 3 months after the ablation

• Rise in procoagulation

  Between 24 hours before the ablation and 24 hours after the ablation

Study Arms (2)

PVI with PVAC gold

ACTIVE COMPARATOR

Patient for pulmonal vein isolation using the PVAC Gold Catheter. Intervention.

Procedure: PVI with Cooled-RF

PVI with Cooled-RF

ACTIVE COMPARATOR

Patient for pulmonal vein isolation using the Cooled-RF catheter.

Procedure: PVI with PVAC gold

Interventions

PVI with PVAC gold PROCEDURE

Pulmonary vein isolation using the Medtronic PVAC gold catheter

Also known as: Medtronic AF solutions

PVI with Cooled-RF

PVI with Cooled-RF PROCEDURE

Pulmonary vein isolation using the Biosense Webster Navistar Thermocool catheter

Also known as: CARTO3 system

PVI with PVAC gold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Serge A. Trines: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 19549035 BACKGROUND

• 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.

  PMID: 19933517 BACKGROUND

• 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.

  PMID: 15133367 BACKGROUND

• 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.

  PMID: 30898234 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Intracranial Embolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Serge A. Trines, MD, PhD

  Cardiology, LUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior cardiologist

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 26, 2011
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 2, 2020

Record last verified: 2020-09

Locations

NL (1)