VOLT CE Mark Study
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.
• Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
• Paroxysmal:
⁃ Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND
⁃ One electrocardiographically documented PAF episodes within 12 months prior to enrollment.
• Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
⁃ Physician's note, AND either
⁃ 24-hour Holter within 180-days prior to enrollment, showing continuous AF, OR
⁃ Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
∙ That are taken at least 7 days apart but less than 12 months apart
‣ If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
‣ The most recent electrocardiogram must be within 180 days of enrollment.
• NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.
• Plans to undergo a PVI catheter ablation procedure due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
• At least 18 years of age
• Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements
• Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.