Evaluation of QDOT MICRO catheter for pulmonary vein isolation (PVI) in subjects with Paroxysmal Atrial Fibrillation (PAF) (Q-fficiency)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Atrial Fibrillation
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects with symptomatic paroxysmal atrial fibrillation (AF) with one electrocardiographically documented AF episode within 6 months prior to enrollment
    2. Subjects have failed at least one (1) antiarrhythmic drug (AAD) (class I or III)
    3. Subjects are at least 18 years old
    4. Subjects are able to complete and sign the written consent form
    5. Subjects are able and willing with all pre-, post- and follow up testing and requirements

You may not be eligible for this study if the following are true:

    1. Subjects who had previous surgical or catheter ablation for atrial fibrillation.
    2. Subjects who had AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
    3. Subjects on amiodarone at any time during the past 3 months prior to enrollment
    4. Subjects previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF lasting > 7 days
    5. Subjects who had CABG surgery within the past 6 months
    6. Subjects who had valvular cardiac surgical/percutaneous procedure
    7. Subjects with any carotid stenting or endarterectomy within the last 6 months
    8. Subjects with Documented LA thrombus on imaging, LA size > 50 mm and LVEF < 40%
    9. Subjects have contraindication to anticoagulation or a history of blood clotting or bleeding abnormalities
    10. Subjects with Documented thromboembolic event
    11. Subjects with Rheumatic Heart Disease or Uncontrolled heart failure or NYHA function class III or IV
    12. Subjects with unstable angina or active systemic infection or sepsis
    13. Subjects with significant pulmonary disease
    14. Subjects with severe Gastroesophageal Reflux Disease
    15. Subjects with significant congenital anomaly or medical problem
    16. Female subjets who are pregnant
    17. Subjects enrolled in an investigational study evaluating another device, biologic, or drug.
    18. Subjects with contra-indication for the devices

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