AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (ABLATE)

AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: AtriCure Bipolar System

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.		6 Months Post Procedure
Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge	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.	30 days Post Procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AtriCure, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 19, 2007
• First Submitted That Met QC Criteria: November 19, 2007
• First Posted (Estimate): November 20, 2007

Study Record Updates

• Last Update Posted (Estimate): March 29, 2013
• Last Update Submitted That Met QC Criteria: March 20, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: atrial fibrillation; ablation; arrhythmia; af; racing heart; afib; surgical ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CP2007-1