AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation (A)

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: NCT00785902
Recruitment Status : Withdrawn
First Posted : November 5, 2008
Last Update Posted : February 21, 2011
Information provided by:
AtriCure, Inc.

Brief Summary:
ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: AtriCure Bipolar System Phase 3

Study Type : Interventional  (Clinical Trial)

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.
  2. The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge

Secondary Outcome Measures :
  1. The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months
  2. The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject is greater than or equal to 18 years of age
  2. Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
  3. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:

    • Mitral valve repair or replacement
    • Aortic valve repair or replacement
    • Tricuspid valve repair or replacement
    • Coronary Artery Bypass procedures
  4. Subject's Left Ventricular Ejection Fraction ≥ 30%
  5. Subject is able and willing to provide written informed consent and comply with study requirements
  6. Subject has life expectancy of at least 1 year

Exclusion Criteria:

  1. Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted
  2. Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
  3. Wolff-Parkinson-White syndrome
  4. Prior cardiac surgery (Redo)
  5. Class IV NYHA heart failure symptoms
  6. Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
  7. Documented MI within 6 weeks prior to study enrollment
  8. Need for emergent cardiac surgery (i.e. cardiogenic shock)
  9. Known carotid artery stenosis greater than 80%
  10. LA size greater than or equal to 8 cm
  11. Current diagnosis of active systemic infection
  12. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
  13. Pregnancy or desire to get pregnant within 12-months of the study enrollment
  14. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
  15. Renal failure requiring dialysis or hepatic failure
  16. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
  17. Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders Identifier: NCT00785902     History of Changes
Other Study ID Numbers: CP2008-1
First Posted: November 5, 2008    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