Two non-thermal ablation techniques approved for routine clinical practice (CE-marked) for the interventional treatment of atrial fibrillation are compared in a 1:1 randomization to investigate patient data, procedural data, effectiveness, and safety.
Patients with paroxysmal atrial fibrillation were randomized 1:1 to undergo pulmonary vein isolation using pulsed field ablation (PFA) with either single-shot PFA (FARAPULSE) or single-tip PFA (Galvanize Therapeutics). Baseline characteristics, procedural data, effectiveness, and safety outcomes were analyzed. In each group, a subset of consecutive patients underwent cerebral magnetic resonance imaging to assess silent cerebral lesions and was scheduled for biomarker assessment (blood sampling) to evaluate inflammation and troponin release after PFA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Pulmonary vein isolation for paroxysmal atrial fibrillation
A subset of consecutive patients of each group (n=25 of each group) receives cMRI on the day after the procedure to asses silent cerebral lesions. A control cMRI is scheduled in case of positive findings.
A subset of patients of each group (n=25 of each group) received blood tests to asses inflammation and troponine release.
Alfried Krupp Hospital
Essen, North Rhine-Westphalia, Germany
Primary outcome: Freedom from arrhythmia
The clinical efficacy, e.g. freedom from atrial arrhythmias / atrial fibrillation is assessed by 5-7 day Holter Monitoring at 3, 6 and 12 months after the procedure. Any documented arrhythmia episode lasting \>30s was calculated as failure. A three months blanking period was considered.
Time frame: 12 months follow-up
Secondary outcomes: Complications, Silent cerebral lesions (cMRI) and biomarker assessments
All peri-procedural complications were noted. In a subset of consecutive patients (n = 25 in each group), cerebral magnetic resonance tomography (cMRI) was performed on the day after the ablation procedure to assess silent cerebral lesions. In case of positive cMRI findings (e.g. silent lesion), repeat cMRI was scheduled in 6 weeks. Biomarker analyses were performed using blood samples, e.g. high-sensitive troponin release at 6, 24 and 48 hours after the ablation as a marker of myocardial injury and C-reactive proteine levels before and 24 hours after the ablation procedure to asses inflammatory response.
Time frame: 6 weeks
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