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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.
Study NCT00571779.   Last updated on June 19, 2008.   Information provided by AtriCure, Inc.

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB
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
Brief Summary

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).
Detailed Description
Study Phase Phase II
Study Type † Interventional
Study Design † Treatment, Non-Randomized, Open Label, Single Group Assignment
Primary Outcome Measure † 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 ]
Secondary Outcome Measure †
Condition † Atrial Fibrillation
Intervention † Device: AtriCure Bipolar System
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Not yet recruiting
Enrollment † 25
Start Date † July 2008
Completion Date December 2010
Eligibility 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
Gender Both
Ages 18 Years to 80 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Madonna Katenkamp     1-800-401-3506     mkatenkamp@atricure.com    
Contact: Deborah Morley     1-800-401-3506     dmorley@atricure.com    
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00571779
Organization ID CP2007-2
Secondary IDs ††
Study Sponsor † AtriCure, Inc.
Collaborators ††
Investigators †
Principal Investigator:     James Edgerton, MD     Baylor Heart Hospital    
Principal Investigator:     Kenneth Ellenbogen, MD     Medical College of Virginia    
Information Provided By AtriCure, Inc.
Verification Date June 2008
First Received Date † December 10, 2007
Last Updated Date June 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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