This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.
The main study is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF). The main study design includes a feasibility sub-study in which additional imaging assessments will be collected in a small cohort of subjects to confirm acute safety of the Volt PFA System in humans. The enrollment extension will include up to an additional 150 subjects enrolled with market-released or investigational devices, depending on enrollment geography.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Pulsed field ablation using the Volt PFA System
The Prince Hospital
Chermside, Queensl, Australia
Royal Adelaide Hospital
Adelaide, Saustrl, Australia
Monash Health
Clayton, Victoria, Australia
Rate of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7-days of any ablation procedure that uses the Volt PFA System.
Serious adverse events are defined as: * Atrio-esophageal fistula * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in permanent diaphragmatic paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Major vascular access complications / major bleeding events * Device and/or procedure 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
Acute procedural effectiveness summarized as the rate of pulmonary veins treated with the Volt PFA system that are isolated at the end of the index ablation procedure.
Acute procedural failure for each pulmonary vein is defined as any of the following: 1. Inability to isolate a pulmonary vein at the end of the index ablation procedure. Isolation will be assessed via confirmation of electrical isolation in each ablated pulmonary vein after a minimum waiting period of 20 minutes via entrance block at a minimum. Touch-up ablation to achieve isolation will be allowed for any pulmonary vein reconnection detected during the index procedure with the investigational catheter (to the maximum delivery allowed per vein) and will not be considered a failure. 2. Any use of a non-study ablation device for pulmonary vein isolation.
Time frame: During procedure
Long-term 6-month effectiveness summarized as the rate of freedom from documented AF/AFL/AT episodes of >30 seconds duration after the index ablation procedure through 6 months of follow-up.
The situations in which subjects will be considered long-term effectiveness endpoint failures: * Acute procedural failure * Any use of a non-study ablation device for pulmonary vein isolation or to deliver ablation lesions in the left atrium during the index procedure or during the first repeat procedure. * If documented AF/AFL/AT recurrence occurs at any time after the blanking period * If subject requires a repeat procedure for the treatment of AF, non-CTI-dependent AFL, or AT after the blanking period or a second repeat AF ablation procedure at any time after the index ablation procedure. * Any use of a new class I or III AAD for AF after the blanking period. * Any use of a class I or III AAD for AF at a dose higher than the historical maximum dose for the subject after the blanking period. * If the subject requires a cardioversion for the treatment of AF/AFL/AT after the blanking period * Surgical treatment of AF/AFL/AT post index procedure.
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Royal Melbourne Hospital - City Campus
Parkville, Victoria, Australia
A. ö. Krankenhaus der Elisabethinen Linz
Linz, UPR AUS, Austria
UZ Brussel
Brussels, Brussels Capital, Belgium
AZ Sint Jan
Bruges, Wflndrs, Belgium
Nemocnice Na Homolce
Prague, Cbohmia, Czechia
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schlesw, Germany
UMC Utrecht
Utrecht, Utrecht, Netherlands
...and 1 more locations
Time frame: 6 months