AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB

Last updated: February 18, 2011
Sponsor: AtriCure, Inc.
Overall Status: Trial Not Available

Phase

2

Condition

Chest Pain

Dysrhythmia

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT00571779
CP2007-2
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient between 18 and 80 years of age

  2. Patient with documented symptomatic persistent or permanent AF and failure orintolerance of one or more Class I or Class III antiarrhythmic drugs.

  • Persistent AF: AF that is not self-terminating or is terminated electrically orpharmacologically.

  • Longstanding AF: Persistent AF of 12 months (or longer) duration.

  • Permanent AF: Longstanding AF in which electrical or pharmacologicalcardioversion has failed or has not been attempted.

  1. Patient is willing and able to provide written informed consent.

  2. Patient has a life expectancy of at least 2 years.

  3. Patient is willing and able to attend the scheduled follow-up visits.

Exclusion

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 ventriculararrhythmia

  13. Presence of thrombus in the left atrium

  14. Co-morbid condition that in the opinion of the investigator poses undue risk ofgeneral 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

Study Design

Study Start date:
Estimated Completion Date: