The occurrence of cerebral embolism (CE) in catheter ablation of atrial fibrillation (AF) using three different ablation catheters

Completed

• Conditions: palpitations; supraventricular tachycardias; 10007521; 10007963; 10007593

• Registration Number: NL-OMON35660
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 270

Inclusion Criteria

Any patient scheduled for a first ablation of paroxysmal atrial fibrillation

Exclusion Criteria

Any patient unwilling or unable to give informed consent
Minors and incapacitated adults
Any patient with contra-indications to DW-MRI of the brain or DE-MRI of the left atrium
Any patient unable to undergo neuropsychological testing due to mental retardation

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. A rise in the procoagulant state, as measured with the following parameters:<br /><br>markers of endothelial damage (VWF:Ag), markers of activated coagulation<br /><br>(D-dimer, prothrombin fragment 1 and 2 (F1+2), and thrombin-antithrombin<br /><br>complex (TAT)), markers of fibrinolysis (tissue plasminogen activator (tPA),<br /><br>plasminogen activator inhibitor 1 (PAI-1), and plasmin-antiplasmin complexes<br /><br>(PAP)), and by measurement of fibrinogen and thrombin generation.<br /><br>2. New embolic lesions on diffusion weighted MRI<br /><br>3. The succes rate of PVI. Success will be defined as symptom-free patients<br /><br>with absence of > 30 sec AF on a 7-day holter recording 12 months after the<br /><br>ablation, </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. New embolic lesions on diffusion weigthed MRI with neuro(psycho)logical<br /><br>symptoms</p><br>