A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation

Participants reporting freedom from documented (asymptomatic and symptomatic) atrial tachyarrhythmias (atrial fibrillation [AF], atrial tachycardia [AT] or atrial flutter [AFL] of unknown origin) episode based on 24-hour Holter will be reported. Additionally, criteria for effectiveness failure included following: 1) Greater (>) than 1 repeat ablations for AF, AT, and AFL of unknown origin in the blanking period or any repeat ablation or surgical treatment for AF, AT, and AFL of unknown origin; 2) Direct current or pharmacological cardioversion for AF, AT, and AFL of unknown origin and; 3) A Class I and/or Class III antiarrhythmic drugs (AAD) is prescribed for AF, AT, and AFL of unknown origin.

Participants reporting freedom from documented (asymptomatic and symptomatic) atrial tachyarrhythmias (AF, AT or AFL of unknown origin) lasting >= 30 seconds based on mobile electrocardiogram (ECG) during the effectiveness evaluation period will be reported.

Acute procedural success, which is defined as confirmation of entrance block in all clinically relevant targeted pulmonary vein (PVs) after drugs challenge or pacing at the end of the index ablation procedure will be reported.

Participants with acute reconnection, which is identified by drugs challenge or pacing among all clinically relevant targeted PVs will be reported.

Participants undergoing repeat ablation within the 12 month follow up period, including timing (blanking period or after blanking) will be reported.

Participants reporting PV re-connection during repeat ablation will be assessed and reported.

The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms.

Total procedure time will be reported.

Mapping time will be reported.

PFA application time will be reported.

Number of PFA ablation will be reported.

Total fluoroscopy time will be reported.

Dwell time is defined as time from first Varipulse catheter insertion in LA until removal from LA.

The ablation parameters setting used for the procedure will be reported.

Participant EP lab time is defined as the time taken for participant on table to leave table, including induction and awakening.

RASS ranges from -5 (unarousable) to +4 (very agitated) , where 0 denotes a calm and alert patient.

VAS score will be measured for intraprocedural pain, discomfort and anxiety and post-procedural groin pain, throat pain and chest pain prior to hospital discharge using 100- point VAS, where 0 = no pain/anxiety/comfort, 100 = worst imaginable pain/anxiety/discomfort. Higher score means greater severity.

Participant's significant movements causing map shifting or CARTO "learning new" warning, and coughs will be reported. Phrenic nerve stimulation not included.

Percentage of participants who need to switch from non-GA to GA will be reported.

Number of participants reporting the use of paralytics and anesthesia, and related drug details will be reported.