AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation

Last updated: March 20, 2013
Sponsor: AtriCure, Inc.
Overall Status: Completed

Phase

3

Condition

Atrial Fibrillation

Chest Pain

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT00560885
CP2007-1
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is greater than or equal to 18 years of age

  2. Subject has history of permanent atrial fibrillation as defined by the ACC/AHA/ESCGuidelines

  3. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for oneor more of the following:

  • Mitral valve repair or replacement

  • Aortic valve repair or replacement

  • Tricuspid valve repair or replacement

  • Coronary Artery Bypass procedures

  • Atrial Septal Defect Repair

  • Patent Foramen Ovale closure

  1. Subject's Left Ventricular Ejection Fraction ≥ 30%

  2. Subject is able and willing to provide written informed consent and comply with studyrequirements

  3. Subject has life expectancy of at least 1 year

Exclusion

Exclusion Criteria:

  1. Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair,or PFO closure

  2. Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgicalMaze 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 isresidual 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 8cm

  11. Current diagnosis of active systemic infection

  12. Severe peripheral arterial occlusive disease defined as claudication with minimalexertion

  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 connectivetissue disorders

Study Design

Total Participants: 55
Study Start date:
November 01, 2007
Estimated Completion Date:
December 31, 2012

Connect with a study center

  • Mercy Heart Institute

    Sacramento, California 95819
    United States

    Site Not Available

  • Sutter Health

    Sacramento, California 95819
    United States

    Site Not Available

  • Heart Center of Indiana

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Spectrum Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Munson Medical Center

    Traverse City, Michigan 49684
    United States

    Site Not Available

  • Baylor Heart Hospital

    Dallas, Texas 75230
    United States

    Site Not Available

  • Inova Fairfax

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia 24014
    United States

    Site Not Available

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