The main purpose of the study is to assess how well the standard ablation procedure (Varipulse Catheter) works over long term when used with different types of anesthesia in participants with symptomatic paroxysmal atrial fibrillation (PAF, irregular heartbeat that comes and goes on its own, causing noticeable symptoms like a racing heart, or shortness of breath).
Diagnosed with I and/or III antiarrhythmic drugs (AAD)-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and/or III AAD based on medical records
Age 18-80 years
Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements
Signed patient informed consent form (ICF)
Atrial fibrillation (AF) secondary to electrolyte imbalance, hyperthyroidism, or reversible or non-cardiac cause
Previous left atrium (LA) ablation or surgery
Left atrium diameter (LAD) greater than (>) 50 millimeters (mm) by transthoracic echocardiography (TTE)
Left ventricular ejection fraction (LVEF) less than (<) 40 percent (%)
The study population will include participants diagnosed with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) or who are intolerable to class I and/or III antiarrhythmic drugs (AAD) based on medical records.
Cohort
Prospective
Not listed
Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode
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.
Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, and AFL
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
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.
Acute Reconnection
Participants with acute reconnection, which is identified by drugs challenge or pacing among all clinically relevant targeted PVs will be reported.
Repeat Ablation
Participants undergoing repeat ablation within the 12 month follow up period, including timing (blanking period or after blanking) will be reported.
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