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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35660

Enrollment

270

Registered

2011-03-30

Start date

2015-03-06

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

palpitations supraventricular tachycardias

Interventions

Pre-treatment with clopidogrel or placebo from 7 days before the procedure until the second day after the procedure.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Any patient scheduled for a first ablation of paroxysmal atrial fibrillation

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
1. New embolic lesions on diffusion weigthed MRI with neuro(psycho)logical symptoms	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)