About this trial
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).
Eligibility criteria
Qualifiers
Diagnosed with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and/or III antiarrhythmic drugs (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)
Disqualifiers
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 (%)
Trial design
Treatments tested in this trial
- Not listed