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AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (ABLATE)
This study is currently recruiting participants.
Verified by AtriCure, Inc., June 2008
Sponsored by: AtriCure, Inc.
Information provided by: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT00560885
  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 III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
MedlinePlus related topics: Heart Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • The primary efficacy endpoint for this study is the 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 ] [ Designated as safety issue: No ]
  • The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status as determined by holter monitoring at 6 months. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • The secondary safety endpoint is the composite 6-month post-procedure major adverse event rate. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: November 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Contacts
Contact: Madonna Katenkamp 1-800-401-3506 mkatenkamp@atricure.com
Contact: Deborah Morley, PhD 1-800-401-3506 dmorley@atricure.com

Locations
United States, California
Mercy Heart Institute Recruiting
Sacramento, California, United States, 95819
Contact: Sarah Bordash, RN, BSN     916-453-4493     sarah.bordash@chw.edu    
Principal Investigator: Alan Morris, MD            
Sutter Health Recruiting
Sacramento, California, United States, 95819
Contact: Linda Frankenstein, RN, BSN, CCRC     916-733-7102     frankel@sutterhealth.org    
Principal Investigator: James Longoria, MD            
United States, Indiana
Heart Center of Indiana Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Mary Anne Gfell     317-583-7812     magfell@corvascmds.com    
Principal Investigator: David Heimansohn, MD            
United States, Michigan
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Julie Bishop, RN, BSN     616-391-2724     julie.bishop@spectrum-health.org    
Principal Investigator: Robert Hooker, MD            
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Jane Stauffer, BSN, CCRC     231-935-6826     jstauffer@mhc.net    
Principal Investigator: Mack Stirling, MD            
United States, Ohio
Case Western Recruiting
Cleveland, Ohio, United States, 44106
Contact: Valerie Cwiklinski, RN     216-844-2328     valerie.cwiklinski@UHhospitals.org    
Principal Investigator: Alan Markowitz, MD            
United States, Texas
Baylor Heart Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Shannon Hoffman, RN         shannon.hoffman@baylorhealth.edu    
Principal Investigator: Michael Mack, MD            
United States, Virginia
Inova Fairfax Recruiting
Falls Church, Virginia, United States, 22042
Contact: Christine Pierre     410-465-2455        
Principal Investigator: Niv Ad, MD            
Carilion Roanoke Memorial Hospital Recruiting
Roanoke, Virginia, United States, 24014
Contact: Barbara Agnew, RN     540-892-6123     bagnew@carilion.com    
Principal Investigator: Joseph Baker, MD            
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Laura Pine, RN, BSN, CCRC     757-668-2732     ljpine@sentara.com    
Principal Investigator: Hormoz Azar, MD            
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Principal Investigator: Niv Ad, MD Inova Heart Hospital
  More Information

Responsible Party: AtriCure, Inc ( Deborah Morley )
Study ID Numbers: CP2007-1
Study First Received: November 19, 2007
Last Updated: June 20, 2008
ClinicalTrials.gov Identifier: NCT00560885  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009