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AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB (RESTORE SR IIB)

This study is not yet open for participant recruitment.
Verified by AtriCure, Inc., June 2008

Sponsored by: AtriCure, Inc.
Information provided by: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT00571779
  Purpose

Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP) ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for patients with permanent or persistent Atrial Fibrillation (AF).


Condition Intervention Phase
Atrial Fibrillation
Device: AtriCure Bipolar System
Phase II

Genetics Home Reference related topics:   Brugada syndrome    familial atrial fibrillation    short QT syndrome   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:   Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation

Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • Feasibility of performing the operation by demonstrating the ability to consistently isolate the left and right pulmonary veins and to confirm conduction block across the roof, anterior and LAA linear lesions. [ Time Frame: Perioperative ] [ Designated as safety issue: No ]
  • The primary safety endpoint will be determined by assessing the rate of serious adverse events. [ Time Frame: Discharge/30 Days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   25
Study Start Date:   July 2008
Estimated Study Completion Date:   December 2010
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

Intervention Details:
    Device: AtriCure Bipolar System
    Surgical ablation using the AtriCure Bipolar System
  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Patient between 18 and 80 years of age
  2. Patient with documented symptomatic persistent or permanent AF and failure or intolerance of one or more Class I or Class III antiarrhythmic drugs.

    • Persistent AF: AF that is not self-terminating or is terminated electrically or pharmacologically.
    • Longstanding AF: Persistent AF of 12 months (or longer) duration.
    • Permanent AF: Longstanding AF in which electrical or pharmacological cardioversion has failed or has not been attempted.
  3. Patient is willing and able to provide written informed consent.
  4. Patient has a life expectancy of at least 2 years.
  5. Patient is willing and able to attend the scheduled follow-up visits.

Exclusion Criteria:

  1. Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months.
  2. Patients who refuse, but have not failed and can tolerate anti-arrhythmic medications
  3. Myocardial infarction within 8 weeks.
  4. Prior cardiac surgery.
  5. Patient requires cardiac surgery for treatment other than for AF.
  6. Class IV NYHA heart failure symptoms, unless due to uncontrolled AF
  7. Cerebrovascular accident within previous 6 months
  8. Known carotid artery stenosis greater than 80%
  9. Evidence of significant active infection
  10. Patient unable to undergo TEE
  11. Pregnant woman
  12. Patient requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
  13. Presence of thrombus in the left atrium
  14. Co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
  15. Patient is enrolled in another cardiac clinical trial
  16. Left ventricular ejection fraction < 30%
  17. Left atrial transverse diameter >6.0
  18. Patient has undergone previous thoracic targeted radiation
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571779

Contacts
Contact: Madonna Katenkamp     1-800-401-3506     mkatenkamp@atricure.com    
Contact: Deborah Morley     1-800-401-3506     dmorley@atricure.com    

Locations
United States, Florida
Shands at University of Florida     Not yet recruiting
      Gainesville, Florida, United States, 32610
      Contact: Nancy Staples     352-273-5496     staplnl@surgery.ufl.edu    
      Principal Investigator: Tom Beaver, MD            
      Principal Investigator: Bill Miles, MD            
United States, Maryland
Johns Hopkins     Not yet recruiting
      Baltimore, Maryland, United States, 21218
      Principal Investigator: David Yuh, MD            
      Principal Investigator: Hugh Calkins, MD            
United States, Ohio
Mt. Carmel East     Not yet recruiting
      Columbus, Ohio, United States, 43213
      Contact: Mary Ann McCleery     614-546-4297     mccleery@mchs.com    
      Principal Investigator: Tom Salamon, MD            
      Principal Investigator: Seth Rials, MD            
United States, Texas
Baylor Heart Hospital     Not yet recruiting
      Plano, Texas, United States, 75093
      Contact: Shannon Hoffman, RN         shannon.hoffman@baylorhealth.edu    
      Principal Investigator: James Edgerton, MD            
      Principal Investigator: Michael Mack, MD            
United States, Virginia
Medical College of Virginia     Not yet recruiting
      Richmond, Virginia, United States, 23298
      Contact: Geoffrey Newton         gnewton@mvch-vcu.edu    
      Principal Investigator: Kenneth Ellenbogen, MD            

Sponsors and Collaborators
AtriCure, Inc.

Investigators
Principal Investigator:     James Edgerton, MD     Baylor Heart Hospital    
Principal Investigator:     Kenneth Ellenbogen, MD     Medical College of Virginia    
  More Information

Responsible Party:   AtriCure, Inc ( Deborah Morley )
Study ID Numbers:   CP2007-2
First Received:   December 10, 2007
Last Updated:   June 19, 2008
ClinicalTrials.gov Identifier:   NCT00571779
Health Authority:   United States: Food and Drug Administration

Keywords provided by AtriCure, Inc.:
Atrial Fibrillation  
AF  
AFIB  
racing heart  
pulmonary vein isolation
pvi
mini maze
maze

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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