This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Pulsed Field Ablation using the Volt PFA System
Ordensklinikum Linz Elisabethinen
Linz, Austria
Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure that uses Volt AF
Serious adverse events are defined as: * Atrio-esophageal fistula * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction * Pericarditis3 * Phrenic nerve injury resulting in permanent diaphragmatic paralysis * Pulmonary Edema * Pulmonary vein stenosis1 * Stroke * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Major vascular access complications4 / major bleeding events5 * Device related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion)
Time frame: 7 days
Long-term Effectiveness will be the proportion of subjects with freedom from documented AF/AFL/AT recurrence through 12-months.
Other situations in which subjects will be considered effectiveness endpoint failures include: * Cardioversion (electrical or pharmaceutical) for the treatment of AF/AFL/AT following the blanking period. * A second repeat procedure for ablation of AF recurrence within the 90-day blanking period * Any repeat ablation procedure in the left atrium (LA) for AF/AFL/AT following the 90-day blanking period * Any use of a new class I or III AAD for AF/AFL/AT after the 90-day blanking period * Any use of a class I or III AAD for AF/AFL/AT at a dose higher than the historical maximum dose for the subject after the blanking period.
Time frame: During procedure
Acute procedural effectiveness is defined as confirmation of entrance block in all targeted pulmonary veins
A secondary measure of confirmation to include any one of the following (the same method must be used for all pulmonary veins) : * A minimum 20-minute wait following initial confirmation of entrance block with a second confirmation of entrance block following the 20-minute wait; or * Exit block pacing maneuvers ; or * Isoproterenol or adenosine challenge
Time frame: During procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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