Atrial Fibrillation
Conditions
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.
Interventions
DEVICEAtriCure Bipolar System
Sponsors
AtriCure, Inc.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
| The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months | — |
| The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate. | — |
Outcome results
None listed