Brief Summary

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.

Conditions

• Paroxysmal AF
• Atrial Arrhythmia
• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention / Treatment

• Device: Pulsed Field Ablation

Primary Outcome Measures

• 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 (7 days)
  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)
• Long-term Effectiveness will be the proportion of subjects with freedom from documented AF/AFL/AT recurrence through 12-months. (During procedure)
  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.
• Acute procedural effectiveness is defined as confirmation of entrance block in all targeted pulmonary veins (During procedure)
  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

Countries

Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden

Locations and Investigators

• Ordensklinikum Linz Elisabethinen, Linz, Austria
• AZ Sint Jan, Bruges, Belgium
• UZ Brussel, Brussels, Belgium
• Rigshospitalet, Copenhagen, Denmark
• Hôpital Pitié Salpetrière, Paris, France
• Hopital Haut Leveque, Pessac, France
• Clinique Pasteur Toulouse, Toulouse, France
• Herz-und Diabetes Zentrum NRW, Bad Oeynhausen, Germany
• Medizinische Einrichtungen der Universität zu Köln, Cologne, Germany
• Asklepios Klinik St. Georg, Hamburg, Germany
• TUM Klinikum - Deutsches Herzzentrum München, München, Germany
• Mater Private Hospital, Dublin, Ireland
• Az. Osp.Universitaria Osp.Riuniti Umberto I-Lancisi-Salesi, Ancona, Italy
• Centro Cardiologico Monzino, Milan, Italy
• Universitair Medisch Centrum Groningen, Groningen, Netherlands
• St. Antonius Ziekenhuis, Nieuwegein, Netherlands
• National Institute of Cardiology Warsaw, Warsaw, Poland
• ULS de Lisboa Ocidental, Lisbon, Portugal
• Hospital Universitario A Coruña, A Coruña, Spain
• Hospital Universitario Doce de Octubre, Madrid, Spain
• Hospital Universitari i Politècnic La Fe, Valencia, Spain
• Karolinska University Hospital Huddinge, Stockholm, Sweden

Study Officials

• Sarah C Kammer (Study Director) — Abbott Medical Devices