Symptomatic Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
HD Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation - Efficiency and Safety of PV Ablation Systems
The purpose of this prospective randomized single-center trial is to compare efficiency and safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® versus the HD Mesh Ablator® catheter.
Primary objective:
• Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary
veins per patient.
Secondary objectives:
- Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain
MRI prior and within 2 days after PV ablation.
- Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain
MRI within 6 months after PV ablation.
- Determination of spontaneous recurrence rate of atrial fibrillation using a
subcutaneously implanted loop recorder (Reveal XT®).
- Characterization of non-neurological major complications (death, atrial-esophageal
fistula, pulmonary vein stenosis, pericardial tamponade)
- Rate of iatrogenic interatrial septal defects after transseptal puncture for PV
ablation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment