Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation.

The purpose of this study is to evaluate safety and acute performance of the THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode in the treatment of Paroxysmal Atrial Fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.

The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.

Inclusion criteria

• Age 18 or older.
• Signed the Patient Informed Consent Form (ICF).
• Diagnosed with symptomatic PAF
• Selected for catheter ablation through pulmonary vein isolation.
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patient not confined by a court ruling).

Exclusion criteria

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Previous surgical or catheter ablation for atrial fibrillation.
• Previously diagnosed with persistent, longstanding AF and/or continuous AF >7 days, or >48 hrs. terminated by cardioversion.
• Documented Left Atrial thrombus on baseline/pre-procedure imaging.
• Any carotid stenting or endarterectomy.
• Left atrial (LA) size >50mm.
• Left Ventricular ejection fraction (LVEF) <40%.
• Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
• History of blood clotting or bleeding abnormalities
• Contraindication to anticoagulation
• History of a documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months.
• Previous percutaneous coronary intervention (PCI) or myocardial Infarction (MI) within the past 2 months.
• Coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (e.g. ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure.
• Rheumatic Heart Disease
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
• Unstable angina.
• Significant pulmonary disease (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other diseaseor malfunction of the lungs or respiratory system that produces chronic symptoms.
• Acute illness, active systemic infection, or sepsis.
• Presence of atrial myxoma, interatrial baffle or patch
• Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
• Presence of a condition that precludes vascular access.
• Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD).
• Presence of IVC filter
• Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.
• Currently enrolled in an investigational study evaluating another device, biologic, or drug.
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
• Life expectancy or other disease processes likely to limit survival to less than 12 months.
• Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use.
• Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
• Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
• Presence of iron-containing metal fragments in the body
• Unresolved pre-existing neurological deficit.