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AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (ABLATE)
This study is ongoing, but not recruiting participants.

First Received on November 19, 2007.   Last Updated on January 23, 2012   History of Changes
Sponsor: AtriCure, Inc.
Information provided by (Responsible Party): 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:


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
Primary Completion Date: December 2009 (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

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
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
Last Updated: January 23, 2012
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 February 09, 2012