Pulsed-Field Ablation With/Without Electrogram Mapping

Laborértékek

• 1. AF that is:a. Paroxysmal (longest AF episode < 7days)b. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes2. Left atrial anteroposterior diameter ≥ 60 mm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)3. Any of the following cardiac conditions:a. Clinically significant arrhythmias other than AF, AFL or ATb. NYHA Class IV CHFc. Atrial or ventricular septal defect closured. Atrial myxomae. History of congenital heart disease with any residual anatomic or conduction abnormality4. Any of the following within 3 months of enrollment:a. Myocardial infarctionb. Unstable anginac. Percutaneous coronary interventiond. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)e. Heart failure hospitalizationf. Stroke or TIAg. Clinically significant bleedingh. Pericarditis or pericardial effusioni. Left atrial thrombus 5. History of blood clotting or bleeding abnormalities.6. Contraindication to, or unwillingness to use, systemic anticoagulation 7. Sensitivity to contrast media not controlled by premedication8. Women of childbearing potential who are pregnant, lactating or not using birth control9. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited toa. Body mass index (BMI) > 40 transplantb. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspneac. Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant d. Active malignancy or history of treated cancer within 24 months of enrollmente. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid refluxf. Clinically significant infectiong. Predicted life expectancy less than one year10. Current or anticipated enrollment in any other clinical study

• 1. Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:a. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agentb. ECG-documented episode of persistent AF lasting longer than 7 days c. Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF2. Patients who are ≥ 18 years and <80 years 3. Patient participation requirements:a. Is willing and capable of providing Informed Consent to undergo study proceduresb. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.