Trial record 1 of 1 for:    NCT00560885
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AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (ABLATE)

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: NCT00560885
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : March 14, 2013
Last Update Posted : March 29, 2013
Information provided by (Responsible Party):
AtriCure, Inc.

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
Study Start Date : November 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AtriCure Bipolar System
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
Device: AtriCure Bipolar System
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

Primary Outcome Measures :
  1. Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months. [ Time Frame: 6 Months Post Procedure ]
  2. Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge [ Time Frame: 30 days Post Procedure ]
    Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.

Secondary Outcome Measures :
  1. Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months. [ Time Frame: 6 Months Post Procedure ]
  2. Composite 6-month Post-procedure Major Adverse Event Rate. [ Time Frame: 6 Months Post Procedure ]

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 permanent 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
    • Atrial Septal Defect Repair
    • Patent Foramen Ovale closure
  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. 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 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 8cm
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00560885

United States, California
Mercy Heart Institute
Sacramento, California, United States, 95819
Sutter Health
Sacramento, California, United States, 95819
United States, Indiana
Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Texas
Baylor Heart Hospital
Dallas, Texas, United States, 75230
United States, Virginia
Inova Fairfax
Falls Church, Virginia, United States, 22042
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
AtriCure, Inc.

Responsible Party: AtriCure, Inc. Identifier: NCT00560885     History of Changes
Other Study ID Numbers: CP2007-1
First Posted: November 20, 2007    Key Record Dates
Results First Posted: March 14, 2013
Last Update Posted: March 29, 2013
Last Verified: March 2013

Keywords provided by AtriCure, Inc.:
atrial fibrillation
racing heart
surgical ablation

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