The main purpose of this study is to investigate the workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE catheter and TRUPULSE generator) when used for cardiac ablation with the new VARIPULSE Pro software in participants with persistent atrial fibrillation (PsAF; irregular, rapid heart rhythm that lasts over 7 days and doesn't stop on its own).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria:
* Diagnosed with symptomatic persistent atrial fibrillation (PsAF)
* Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) +
* Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD
* Age 18-75 years
* Willing and capable of providing consent
* Able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion criteria:
* Continuous AF greater than (\>) 12 months (1-Year) (Longstanding Persistent AF)
* Previous surgical or catheter ablation for atrial fibrillation
* Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention \[PCI\])
* Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure
* Any carotid stenting or endarterectomy
* Presence of left atrium (LA) thrombus
* Severe dilatation of the LA (left atrial diameter (LAD) \> 50 millimeter \[mm\] antero-posterior diameter in case of transthoracic echocardiography \[TTE\])
* Severely compromised left ventricular ejection fraction (LVEF less than \[\<\] 40%)
* Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
* Prior diagnosis…
What they're measuring
1
Total Procedure Time
Timeframe: Intraoperative
2
Pulsed Field (PF) Application Time
Timeframe: Intraoperative
3
Number of PF applications by Pulmonary Vein (PV)
Timeframe: Intraoperative
4
Number of PF applications by Other Cardiac Locations