Last updated on October 2018

CFAE/Spatiotemporal Dispersion Guided Ablation Versus PVI Guided Ablation in Persistent AF

Are you eligible to participate in this study?

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

  • Conditions: Chronic Atrial Fibrillation
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Patients with persistent atrial fibrillation, defined as atrial fibrillation which is:
  2. Sustained beyond 7 days but no more than one year.
  3. Or lasting less than 7 days, but longer than 48 hours and necessitating pharmacologic or electrical cardioversion.
  4. Documentation of atrial fibrillation on either a 12-lead ECG or transtelephonic monitoring (TTM), or ambulatory holter monitoring or telemetry strip and a physician's note showing continuous AF.
  5. Failure of at least one AAD (Class I or III) as evidenced by recurrent symptomatic AF or intolerable side effects of the AAD.
  6. Signed Patient Informed Consent Form.
  7. Age 18 years or older.
  8. Able and willing to comply with all pre- and follow-up testing and requirements.

Exclusion Criteria:

  1. Continuous AF > 12 months (1-Year) (Longstanding Persistent AF).
  2. Previous surgical or catheter ablation for atrial fibrillation.
  3. Any cardiac surgery within the past 2 months (60 days) (includes PCI).
  4. CABG surgery within the past 6 months (180 days).
  5. Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
  6. Cardioversion refractory (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion).
  7. If a patient does not have documented evidence of being successfully cardioverted (NSR > 30 secs), the patient must be cardioverted prior to the ablation procedure with the study catheter.
  8. Failure to cardiovert based on the above criteria is considered a screen failure.
  9. Documented LA thrombus on imaging.
  10. LA size >50 mm.
  11. LVEF < 30%.
  12. Contraindication to anticoagulation (heparin or warfarin).
  13. History of blood clotting or bleeding abnormalities.
  14. Myocardial infarction within the past 2 months (60 days).
  15. Documented thromboembolic event (including TIA) within the past 12 months (365 days).
  16. Rheumatic Heart Disease.
  17. Uncontrolled heart failure or NYHA function class III or IV.
  18. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days).
  19. Unstable angina.
  20. Acute illness or active systemic infection or sepsis.
  21. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  22. Diagnosed atrial myxoma.
  23. Presence of implanted ICD.
  24. Significant severe 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.
  25. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
  26. Women who are pregnant (as evidenced by pregnancy test if pre- menopausal).
  27. Enrollment in an investigational study evaluating another device, biologic, or drug.
  28. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
  29. Presence of a condition that precludes vascular access.
  30. Life expectancy or other disease processes likely to limit survival to less than 12 months.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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