AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation

NCT ID: NCT00785902

Last Updated: 2011-02-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL

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.

Conditions

Atrial Fibrillation

Interventions

AtriCure Bipolar System

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AtriCure, Inc.

INDUSTRY

Sponsor Role: lead

Other Identifiers

CP2008-1

Identifier Type: -

Identifier Source: org_study_id