The VARIFY study is designed to find out how durable pulmonary vein isolation (PVI) is after treatment with the VARIPULSE pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation (AF). AF is a common heart rhythm disorder caused by abnormal electrical signals coming from the pulmonary veins. In a PVI procedure, these veins are electrically isolated to prevent AF from recurring. Sometimes, the veins reconnect over time, which can lead to a return of arrhythmia. PFA is a new, non-thermal technology that uses short electrical pulses to safely and precisely treat heart tissue, reducing the risk of damage to nearby structures. The VARIPULSE system is one of these new PFA platforms. In this study, 20 adult patients with paroxysmal AF will undergo PVI using the VARIPULSE system. After 2-3 months, each patient will have a second planned procedure to check whether the pulmonary veins remain isolated. Any reconnections found will be treated immediately. The main goal is to determine how often the pulmonary veins stay durably isolated after the initial VARIPULSE treatment. Secondary goals include assessing the amount of scar tissue in the left atrium, recording any complications, and evaluating rhythm outcomes after one year. The results will help determine how effective and reliable the VARIPULSE system is for long-term treatment of AF.
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Single group
Pulmonary vein isolation with the VariPulse catheter
DevicePulmonary vein isolation with the VariPulse catheter
Percentage of pulmonary veins which shows reconnection during the repeat procedure 2-3 months after the index procedure
During the repeat procedure (2-3 months after the index procedure) the number of pulmonary veins which shows reconnection will be determined. The primary outcome measure is the percentage of pulmonary veins with reconnection.
Extent of low voltage area in the left atrium identified at the repeat procedure 2-3 months after the index procedure
The low voltage area (\<0.5 mV) in the left atrium will be identified during the repeat procedure using high-density 3D-mapping with the OCTARAY catheter.
One-year freedom from atrial arrhythmia after a blanking period of 3 months.
Recurrence of any atrial arrhythmia will be defined as the documentation of atrial arrhythmia on a standard 12-lead ECG or the documentation of ≥30 seconds of atrial arrhythmia on a Holter after a blanking period of 3 months. Twenty-four Holter monitoring will be performed at 6 and 12 months after the ablation procedure.
Percentage of patients with a procedure-related complication
All procedure-related complications will be identified from the index procedure till the 1-year follow-up visit.
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Erasmus Medical Center
Lead sponsor
Biosense Webster, Inc.
Collaborator
