Concomitant Treatment of Permanent Atrial Fibrillation

Completed · Phase 3

Conditions studied: Atrial Fibrillation

In brief

RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System

Key facts

Study ID

NCT00566787

Run by

AtriCure, Inc.

People needed

39

Starts

2005-01-01

Expected to finish

2010-11-01

Last updated by the study team

2012-01-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female subject between 18 to 80 years of age
• Subject is scheduled to undergo elective cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including:
• coronary artery bypass and/or
• mitral valve surgery (repair or replacement)
• aortic valve surgery (repair or replacement)
• tricuspid valve surgery (repair or replacement)
• Left Ventricular Ejection Fraction ≥ 30%
• Subject is willing and able to provide written informed consent
• Subject has a life expectancy of at least 2 years
• Subject is willing and able to return for scheduled follow-up visits
• TREATMENT SUBJECTS ONLY: Subject has a 3 month documented history of continuous atrial fibrillation
• CONTROL SUBJECTS ONLY: Subject is not in atrial fibrillation at time of surgery

You may not qualify if…

• Lone AF without indication(s) for concomitant CABG and/or mitral valve surgery, aortic valve surgery, tricuspid valve surgery or double valve surgery
• Prior cardiac surgery (Redo -including previous ablation)
• Patient requires atrial septal defect repair or any other concomitant open-heart procedure, other than CABG and/or mitral valve surgery; aortic valve surgery, tricuspid valve surgery or double valve surgery
• Serum creatinine concentration greater than 2.0 mg/dl
• Class IV NYHA heart failure symptoms and/or Class IV CCS anginal symptoms
• Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurologic deficit
• Active infection
• Known carotid artery stenosis greater than 80%
• Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
• A known drug and/or alcohol addiction
• Mental impairment or other conditions which may not allow the the subject to understand the nature, significance and scope of the study
• Pregnancy or desire to get pregnant within 12 months of study enrollment
• Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia

Where it is running

• Heart Center of Indiana — Indianapolis, Indiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Methodist Hospital — Houston, Texas, United States
• Sentara Norfolk Hospital — Norfolk, Virginia, United States
• Sacred Heart Medical Center — Seattle, Washington, United States
• St. Mary's Hospital Medical Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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