Clinical trial NCT00560885: AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
Official title: AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
af
ablation
arrhythmia
racing heart
afib
surgical ablation
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-20
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.
timeFrame: 6 Months Post Procedure
measure: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
timeFrame: 30 days Post Procedure
Secondary outcomes:
measure: Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.
timeFrame: 6 Months Post Procedure
measure: Composite 6-month Post-procedure Major Adverse Event Rate.
timeFrame: 6 Months Post Procedure
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Mercy Heart Institute
state: California
city: Sacramento
country: United States
facility: Sutter Health
state: California
city: Indianapolis
country: United States
facility: Heart Center of Indiana
state: Indiana
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Dallas
country: United States
facility: Baylor Heart Hospital
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
Study officials:
References: