AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation

Completed · Phase 3

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT00560885

Run by

AtriCure, Inc.

People needed

55

Starts

2007-11-01

Expected to finish

2012-12-01

Last updated by the study team

2013-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mercy Heart Institute — Sacramento, California, United States
• Sutter Health — Sacramento, California, United States
• Heart Center of Indiana — Indianapolis, Indiana, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Munson Medical Center — Traverse City, 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.