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

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. Identifier: NCT00571779
Recruitment Status : Withdrawn
First Posted : December 12, 2007
Last Update Posted : February 21, 2011
Information provided by:
AtriCure, Inc.

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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: AtriCure Bipolar System Phase 2

Study Type : Interventional  (Clinical Trial)
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.
  2. The primary safety endpoint will be determined by assessing the rate of serious adverse events.

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. 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 Identifier: NCT00571779     History of Changes
Other Study ID Numbers: CP2007-2
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes