Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott Medical Devices
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18 years or older
Signed Patient Informed Consent Form
Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation\* \[class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)\] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation\*, or intolerable side effects due to AAD
Subjects with symptomatic paroxysmal atrial fibrillation (PAF)\*
* PAF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven days.
You may not be if
Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Previous ablation for AF
History of any valvular cardiac surgical procedure
Coronary artery bypass grafting (CABG) procedure within the last six months
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
Left atrial thrombus
History of a documented thromboembolic event within the past one (1) year
Diagnosed atrial myxoma
An implanted implantable cardioverter defibrillator (ICD)
Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable)
Acute illness or active systemic infection or sepsis
Unstable angina
Myocardial infarction within the previous two months
Left ventricular ejection fraction (LVEF) \<40% as determined by pre-procedure transthoracic echocardiogram (TTE)
History of blood clotting or bleeding abnormalities
Contraindication to anticoagulation (i.e. heparin or warfarin)
Contraindication to computed tomography/magnetic resonance angiography (CT/MRA) procedure
Life expectancy less than 12 months
Enrollment in an investigational study evaluating another device or drug
Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart failure
An intramural thrombus tumor, or other abnormality that precludes catheter introduction or manipulation
Presence of a condition that precludes vascular access
Left atrial size ≥ 50 mm as determined by pre-procedure TTE
