Text Size

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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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 Intervention Phase
Atrial Fibrillation
 Device: AtriCure Bipolar System
 Phase 2

Study Type: Interventional
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 NLM:

U.S. FDA Resources

Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00571779     History of Changes
Other Study ID Numbers: CP2007-2
Study First Received: December 10, 2007
Last Updated: February 18, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013