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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT00571779
First received: December 10, 2007
Last updated: February 18, 2011
Last verified: February 2011

December 10, 2007
February 18, 2011
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  • 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.
  • The primary safety endpoint will be determined by assessing the rate of serious adverse events.
  • 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 ]
Complete list of historical versions of study NCT00571779 on ClinicalTrials.gov Archive Site
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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).

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Interventional
Phase 2
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Atrial Fibrillation
Device: AtriCure Bipolar System
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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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 information is only displayed when the study is recruiting subjects
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NCT00571779
CP2007-2
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AtriCure, Inc.
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AtriCure, Inc.
February 2011

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