Low Voltage-Directed Catheter Ablation for Atrial Fibrillation

Eligibility Criteria

• 1. Non-Paroxysmal Atrial Fibrillation.
• 2. Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
• 3. 18-85 year of age at time of consent.
• 4. Scheduled to undergo a clinically indicated AF ablation procedure.
• 5. Able and willing to comply with all protocol visit requirements.
• 6. Signed Patient Informed Consent (ICF).
• 7. Presence of low voltage in the left atrium on 3-D map during index catheter ablation procedure
• 1. History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE.
• * Prior ablation for typical atrial flutter or left-sided ablation for WPW, AV node reentry tachycardia or focal ectopic atrial tachycardia may be included.
• 2. Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure.
• 3. Ejection Fraction \< 0.20.
• 4. Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months.
• 5. Left atrial size \> 60 mm diameter on echocardiogram.
• 6. "Long standing" persistent AF defined as \> or = 1 year of continuous atrial fibrillation at the time of enrollment.
• 7. Severe pulmonary hypertension (PAP \> 70 mmHg)
• 8. Unstable valvular disease.
• 9. AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause.
• 10. Poor candidate for general anesthesia.
• 11. Anticipated survival \< 1 year.
• 12. MI or CABG within 3 months.
• 13. Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.
• 14. Any documented thromboembolic event within 6 months of the ablation procedure.
• 15. Contraindication to anticoagulation.
• 16. Inability to have implantable monitoring device for atrial fibrillation burden with no pre-existing cardiac device that can monitor atrial arrhythmias OR inability to wear external Holter Monitor continuously for 4 weeks.
• 17. Significant congenital anomaly or medical condition that may affect the integrity of study data.
• 18. Women who are pregnant - pregnancy test required if pre-menopausal or non-sterile.
• 19. Active enrollment in another investigational study involving a drug or device.
• 20. Inability to undergo complete voltage mapping in normal sinus rhythm - see intraprocedural protocol.
• 21. Presence of any medical or psychological condition or medical non-compliance history that may adversely impact study outcomes.