SMART China, A Multi-center Clinical Registry Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: THERMOCOOL® SMARTTOUCH™
Intervention description: Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Interventional; Radiofrequency ablation; Paroxysmal Atrial Fibrillation; Catheter ablation

Summary:

      This is a prospective effectiveness and safety assessment of the study device during
      radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial
      fibrillation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years or older

          2. Failure of at least one antiarrhythmic drug (AAD) for AF (class I or III, or AV nodal
             blocking agents such as beta blockers and calcium channel blockers) as evidenced by
             recurrent symptomatic AF, or intolerance to the AAD

          3. Patients with paroxysmal AF eligible for catheter ablation

          4. Patients with symptomatic PAF who have had at least one documented AF episode in the
             twelve (12) months prior to enrollment. Documentation may include but is not limited
             to electrocardiogram (ECG), Holter monitor (HM) or transtelephonic monitor (TTM)

          5. Able and willing to comply with all pre-, post- and follow-up testing and requirements

          6. Be able to sign IRB/EC-approved informed consent form

        Exclusion Criteria:

          1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac
             cause

          2. Previous surgical or catheter ablation for AF

          3. Any PCI, cardiac surgery, or valvular cardiac surgical or percutaneous procedure
             (e.g., ventriculotomy, atriotomy, and valve repart or replacement and presence of a
             prosthetic valve) within the past 2 months.

          4. Any carotid stenting or endarterectomy.

          5. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months)

          6. AF episodes lasting longer than 7 days or terminated via cardioversion

          7. Documented left atrial thrombus on imaging

          8. Uncontrolled heart Failure or New York Heart Association (NYHA) class III or IV

          9. Myocardial Infarction within the previous 60 days (2 months)

         10. Documented thromboembolic event (including TIA) within the past 12 months

         11. Rheumatic heart disease

         12. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12
             months)

         13. 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.

         14. Significant congenital anomaly or medical problem that in the opinion of the
             investigator would preclude enrollment in this study

         15. Active illness or active systemic infection or sepsis

         16. Diagnosed atrial myxoma

         17. Unstable angina within the past 60 days (2 months)

         18. History of blood clotting or bleeding abnormalities

         19. Life expectancy less than 365 days (12 months)

         20. Hypertrophic obstructive cardiomyopathy

         21. Presence of implanted ICD

         22. Contraindication to anticoagulation

         23. Contraindication to isoproterenol

         24. Presence of intramural thrombus, tumor or other abnormality that precludes catheter
             introduction or manipulation

         25. Women who are pregnant and/or breast feeding

         26. Presence of a condition that precludes vascular access.

         27. Patients presenting contraindications for study catheter(s), as indicated in the
             respective Instructions For Use

         28. Enrollment in an investigational study evaluating another device, biologic, or drug.