SMART-SF Radiofrequency Ablation Safety Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: THERMOCOOL® SMARTTOUCH® (RF ablation treatment)
Intervention description: Radiofrequency Ablation Treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Interventional; Radiofrequency ablation; Paroxysmal Atrial Fibrillation

Summary:

      This is a prospective safety assessment of the study device during radiofrequency (RF)
      ablation treatment of patients with drug refractory symptomatic atrial fibrillation
      (SMART-SF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic paroxysmal atrial fibrillation (AF) who have had at least one AF episode
             electrocardiographically documented within one (1) year prior to enrollment and a
             physician's note indicating recurrent, self-terminating AF. Electrocardiographic
             documentation may include, but is not limited to, electrocardiogram (ECG),
             transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip

          -  Failed at least one antiarrhythmic drug (AAD) (class I or III, or atrioventricular
             (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as
             evidenced by recurrent symptomatic AF, or intolerable to the AAD

          -  Age 18 years or older

        Exclusion Criteria:

          -  Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible
             or non-cardiac cause

          -  Previous surgical or catheter ablation for atrial fibrillation

          -  Amiodarone at any time during the past 3 months

          -  Any percutaneous coronary intervention (PCI), cardiac surgery, or valvular cardiac
             surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair
             or replacement and presence of a prosthetic valve) within the past 2 months

          -  Any carotid stenting or endarterectomy

          -  Coronary artery bypass graft (CABG) surgery within the past 6 months

          -  AF episodes lasting >7 days

          -  Documented left atrial (LA) thrombus on imaging

          -  LA size >50 mm

          -  Left ventricular ejection fraction (LVEF) < 40%

          -  Contraindication to anticoagulation (heparin or warfarin)

          -  History of blood clotting or bleeding abnormalities

          -  MI within the past 2 months

          -  Documented thromboembolic event (including transient ischemic attack (TIA)) within the
             past 12 months

          -  Rheumatic Heart Disease

          -  Uncontrolled heart failure or New York Heart Association (NYHA) function class III or
             IV

          -  Awaiting cardiac transplantation or other cardiac surgery within the next 12 months

          -  Unstable angina

          -  Acute illness or active systemic infection or sepsis

          -  Diagnosed atrial myxoma

          -  Presence of implanted implantable cardioverter defibrillator (ICD)

          -  Significant pulmonary disease, (eg, 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 (as evidenced by pregnancy test if pre-menopausal)

          -  Enrollment in an investigational study evaluating another device, biologic, or drug

          -  Presence of intramural thrombus, tumor or other abnormality that precludes vascular
             access, or manipulation of the catheter

          -  Presence of a condition that precludes vascular access

          -  Life expectancy or other disease processes likely to limit survival to less than 6
             months