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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   Information provided by AtriCure, Inc.
First Received: December 10, 2007   Last Updated: August 24, 2009   History of Changes

December 10, 2007
August 24, 2009
November 2009
December 2011   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00571779 on ClinicalTrials.gov Archive Site
 
 
 
AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB
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

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).

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment
Atrial Fibrillation
Device: AtriCure Bipolar System
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
25
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Madonna Katenkamp 1-800-401-3506 mkatenkamp@atricure.com
Contact: Deborah Morley 1-800-401-3506 dmorley@atricure.com
United States
 
NCT00571779
Deborah Morley, AtriCure, Inc
CP2007-2
AtriCure, Inc.
 
Principal Investigator: James Edgerton, MD Baylor Heart Hospital
Principal Investigator: Kenneth Ellenbogen, MD Medical College of Virginia
AtriCure, Inc.
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP