Evaluation of Ablation Index and VISITAG™ (ABI-173)

Inclusion criteria

• Symptomatic paroxysmal AF who had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), holter monitor or telemetry strip
• Failed at least one antiarrhythmic drug (AAD) (Type I or III, including β-blocker) as evidenced by recurrent symptomatic AF, or intolerance to the AAD
• Age 18 years or older
• Signed Patient Informed Consent Form (ICF)
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion criteria

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Previous LA ablation or surgery
• Anticipated to receive ablation outside the PV ostia and CTI region
• Previously diagnosed with persistent AF (> 7 days in duration)
• LA size >50 mm
• LA thrombus
• LVEF < 40%
• Uncontrolled heart failure or NYHA Class III or IV
• History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
• History of a documented thromboembolic event (including TIA) within the past 6 months
• Previous PCI/MI within the past 3 months
• Previous cardiac surgery (e.g. CABG) within the past 6 months
• Previous valvular cardiac surgical/percutaneous procedure (e.g. ventriculotomy, atriomy, valve repair or replacement, presence of a prosthetic valve)
• Unstable angina pectoris
• Awaiting cardiac transplantation, cardiac surgery or other major surgery within the next 12 months.
• 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
• Acute illness, active systemic infection or sepsis
• Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
• Presence of a condition that precludes vascular access
• Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial
• Current enrollment in an investigational study evaluating another device or drug.
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
• Life expectancy less than 12 months
• Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use