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AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (ABLATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT00560885
First received: November 19, 2007
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Atrial Fibrillation
 Device: AtriCure Bipolar System
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge [ Time Frame: 30 days Post Procedure ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
  • Composite 6-month Post-procedure Major Adverse Event Rate. [ Time Frame: 6 Months Post Procedure ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: November 2007
Study Completion Date: December 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560885

Locations
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.
  More Information

No publications provided

Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT00560885     History of Changes
Other Study ID Numbers: CP2007-1
Study First Received: November 19, 2007
Results First Received: February 11, 2013
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 16, 2013