AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Subject is greater than or equal to 18 years of age
Subject has history of permanent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
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
Subject's Left Ventricular Ejection Fraction ≥ 30%
Subject is able and willing to provide written informed consent and comply with study requirements
Subject has life expectancy of at least 1 year

Exclusion Criteria

Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair, or PFO closure
Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
Wolff-Parkinson-White syndrome
Prior cardiac surgery (Redo)
Class IV NYHA heart failure symptoms
Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
Documented MI within 6 weeks prior to study enrollment
Need for emergent cardiac surgery (i.e. cardiogenic shock)
Known carotid artery stenosis greater than 80%
LA size greater than or equal to 8cm
Current diagnosis of active systemic infection
Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
Pregnancy or desire to get pregnant within 12-months of the study enrollment
Preoperative need for an intra-aortic balloon pump or intravenous inotropes
Renal failure requiring dialysis or hepatic failure
Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge	30 days Post Procedure	Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.
Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.	6 Months Post Procedure

Secondary Outcome Measures

Name	Time	Method
Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.	6 Months Post Procedure
Composite 6-month Post-procedure Major Adverse Event Rate.	6 Months Post Procedure

Locations (9): Mercy Heart Institute
🇺🇸
Sacramento, California, United States
Sutter Health
🇺🇸
Sacramento, California, United States
Heart Center of Indiana
🇺🇸
Indianapolis, Indiana, United States
Munson Medical Center
🇺🇸
Traverse City, Michigan, United States
Spectrum Health
🇺🇸
Grand Rapids, Michigan, United States
Baylor Heart Hospital
🇺🇸
Dallas, Texas, United States
Inova Fairfax
🇺🇸
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Carilion Roanoke Memorial Hospital
🇺🇸
Roanoke, Virginia, United States