AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (ABLATE)

AtriCure

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Device: AtriCure Bipolar System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560885

CP2007-1

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is greater than or equal to 18 years of age

2. Subject has history of permanent 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
   • Atrial Septal Defect Repair
   • Patent Foramen Ovale closure

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. Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair, or PFO closure
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 8cm
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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

AtriCure Bipolar System

Experimental group

Description:

The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.

Treatment:

Device: AtriCure Bipolar System