Clinical trial NCT00785902: AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Atrial Fibrillation
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.


Eligibility criteria: Inclusion Criteria:

1. Subject is greater than or equal to 18 years of age
2. Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
3. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:

   * Mitral valve repair or replacement
   * Aortic valve repair or replacement
   * Tricuspid valve repair or replacement
   * Coronary Artery Bypass procedures
4. Subject's Left Ventricular Ejection Fraction ≥ 30%
5. Subject is able and willing to provide written informed consent and comply with study requirements
6. Subject has life expectancy of at least 1 year

Exclusion Criteria:

1. Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted
2. Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
3. Wolff-Parkinson-White syndrome
4. Prior cardiac surgery (Redo)
5. Class IV NYHA heart failure symptoms
6. Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
7. Documented MI within 6 weeks prior to study enrollment
8. Need for emergent cardiac surgery (i.e. cardiogenic shock)
9. Known carotid artery stenosis greater than 80%
10. LA size greater than or equal to 8 cm
11. Current diagnosis of active systemic infection
12. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
13. Pregnancy or desire to get pregnant within 12-months of the study enrollment
14. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
15. Renal failure requiring dialysis or hepatic failure
16. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
17. Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders

Primary outcomes:
measure: The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.
measure: The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge
Secondary outcomes:
measure: The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months
measure: The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.
Other outcomes:
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