AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— ABLATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560885
• Other study ID #: CP2007-1
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2007
• Last updated: March 20, 2013
• Start date: November 2007
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2012
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• AtriCure Bipolar System
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

Locations

Country	Name	City	State
United States	Baylor Heart Hospital	Dallas	Texas
United States	Inova Fairfax	Falls Church	Virginia
United States	Spectrum Health	Grand Rapids	Michigan
United States	Heart Center of Indiana	Indianapolis	Indiana
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Mercy Heart Institute	Sacramento	California
United States	Sutter Health	Sacramento	California
United States	Munson Medical Center	Traverse City	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.		6 Months Post Procedure	No
Secondary	Composite 6-month Post-procedure Major Adverse Event Rate.		6 Months Post Procedure	Yes