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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
âś“. 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
âś“. At least 18 years of age
âś“. Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements
âś“. 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.
Exclusion criteria
âś•. Previously diagnosed long-standing persistent atrial fibrillation (AF greater than 1 year in duration)
âś•. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
âś•. Participant known to require ablation beyond PVI at the time of consent (Main study only)
âś•. Known presence of cardiac thrombus
✕. Left atrial diameter ≥ 5.5 cm (anteroposterior diameter)
âś•. Left ventricular ejection fraction \< 35% as assessed with echocardiography within 180 days of index procedure
What they're measuring
1
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.
Timeframe: 7-days
2
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.
Timeframe: During procedure
3
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.