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Concomitant Treatment of Permanent Atrial Fibrillation (RESTORE SR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00566787
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : January 25, 2012
Information provided by (Responsible Party):
AtriCure, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center Study With Case Matched Controls to Evaluate the Safety and Efficacy of the AtriCure Bipolar System for the Treatment of Continuous Atrial Fibrillation as Adjunct Therapy to Elective Open Heart Surgery
Study Start Date : January 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
    Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

Primary Outcome Measures :
  1. Primary efficacy endpoint is the proportion of treated patients who are free of atrial fibrillation without the need for anti-arrhythmic agents at the six-month follow-up visit. [ Time Frame: 6 months ]
  2. The primary safety endpoint is the occurrence of serious adverse events that are considered to be associated with the Maze procedure. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. The secondary efficacy endpoint is the proportion of patients in the treatment group who are free of atrial fibrillation independent of the need for anti-arrhythmic drugs. [ Time Frame: 6 Months ]
  2. The secondary safety endpoints are: total cross clamp time, total time on bypass, length of hospital stay (days), and length of ICU stay (hours) [ Time Frame: Discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or Female subject between 18 to 80 years of age
  2. 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)
  3. Left Ventricular Ejection Fraction ≥ 30%
  4. Subject is willing and able to provide written informed consent
  5. Subject has a life expectancy of at least 2 years
  6. Subject is willing and able to return for scheduled follow-up visits
  7. TREATMENT SUBJECTS ONLY: Subject has a 3 month documented history of continuous atrial fibrillation
  8. CONTROL SUBJECTS ONLY: Subject is not in atrial fibrillation at time of surgery

Exclusion Criteria:

  1. Lone AF without indication(s) for concomitant CABG and/or mitral valve surgery, aortic valve surgery, tricuspid valve surgery or double valve surgery
  2. Prior cardiac surgery (Redo -including previous ablation)
  3. 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
  4. Serum creatinine concentration greater than 2.0 mg/dl
  5. Class IV NYHA heart failure symptoms and/or Class IV CCS anginal symptoms
  6. Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurologic deficit
  7. Active infection
  8. Known carotid artery stenosis greater than 80%
  9. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
  10. A known drug and/or alcohol addiction
  11. Mental impairment or other conditions which may not allow the the subject to understand the nature, significance and scope of the study
  12. Pregnancy or desire to get pregnant within 12 months of study enrollment
  13. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566787

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United States, Indiana
Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Spectrum Health
Grand Rapids, Michigan, United States, 49506
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
Sentara Norfolk Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
Sacred Heart Medical Center
Seattle, Washington, United States, 99220
United States, Wisconsin
St. Mary's Hospital Medical Center
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
AtriCure, Inc.
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Principal Investigator: A. Marc Gillinov, MD The Cleveland Clinic
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Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT00566787    
Other Study ID Numbers: CP2003-1
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: January 2012
Keywords provided by AtriCure, Inc.:
Atrial Fibrillation
racing heart
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes