Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Catheter ablation with EPU
Intervention description: Subjects undergoing electrophysiology mapping and RF ablation with THERMOCOOL SMARTTOUCH ® SF (STSF) and THERMOCOOL SMARTTOUCH ® (ST) catheters with VISITAG SURPOINT Module with External Processing Unit for pulmonary vein isolation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 333.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module
      with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to
      an historical control performance goal.

      A maximum of 330 subjects will be enrolled across up to 45 sites. Two hundred eighty (280)
      enrolled subjects will be treated using the STSF catheter with EPU and 50 subjects will be
      treated using the ST catheter with EPU. Prior to enrollment, a few sites will be selected to
      only enroll subjects who will be treated with the ST catheter and the remaining sites will
      only enroll subjects who will be treated with the STSF catheter.

      Bayesian adaptive design will be used to assess early success at up to two interims: one
      after all subjects have completed the 3- month follow-up assessment, and a second to occur
      after all subjects have completed the 6 months follow-up visit.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet all of the following inclusion criteria to be eligible for participation
        in this study:

          1. 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

          2. Failed at least one antiarrhythmic drug (AAD) (Class I or III antiarrhythmic drugs) as
             evidenced by recurrent symptomatic AF, or intolerable to the AAD

          3. Age 18 years or older

          4. Signed Patient Informed Consent Form (ICF)

          5. Able and willing to comply with all pre-, post-, and follow-up testing and
             requirements

        Exclusion Criteria:

        Subjects who meet any of the following exclusion criteria are not eligible for enrollment.

          1. Previous surgical or catheter ablation for atrial fibrillation

          2. Previous cardiac surgery (including CABG) within the past 6 months (180 days)

          3. Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and
             valve repair or replacement and presence of a prosthetic valve)

          4. Any carotid stenting or endarterectomy

          5. Documented LA thrombus on imaging

          6. LA size > 50 mm (parasternal long axis view)

          7. LVEF < 40%

          8. Contraindication to anticoagulation (heparin or warfarin)

          9. History of blood clotting or bleeding abnormalities

         10. PCI/MI within the past 2 months (60 days)

         11. Documented thromboembolic event (including TIA) within the past 12 months (365 days)

         12. Rheumatic Heart Disease

         13. Uncontrolled heart failure or NYHA function class III or IV

         14. Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥
             50%, and/or Effective regurgitant orifice area ≥ 0.40cm2)

         15. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
             (365 days)

         16. Unstable angina

         17. Acute illness or active systemic infection or sepsis

         18. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac
             cause.

         19. Presence of implanted ICD/CRT-D.

         20. 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.

         21. Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not
             including OTC medication)

         22. Significant congenital anomaly or medical problem that in the opinion of the
             investigator would preclude enrollment in this study.

         23. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)

         24. Concurrent enrollment in an investigational study evaluating another device, biologic,
             or drug.

         25. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other
             abnormality that precludes vascular access, or manipulation of the catheter.

         26. Life expectancy less than 12 months