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
1 other identifier
interventional
55
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 atrial-fibrillation
Started Nov 2007
Longer than P75 for phase_3 atrial-fibrillation
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 19, 2007
CompletedFirst Posted
Study publicly available on registry
November 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
March 14, 2013
CompletedMarch 29, 2013
March 1, 2013
2.1 years
November 19, 2007
February 11, 2013
March 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Study Arms (1)
AtriCure Bipolar System
EXPERIMENTALThe AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
Interventions
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Eligibility Criteria
You may qualify if:
- Subject is greater than or equal to 18 years of age
- Subject has history of permanent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
- 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
- Subject's Left Ventricular Ejection Fraction ≥ 30%
- Subject is able and willing to provide written informed consent and comply with study requirements
- Subject has life expectancy of at least 1 year
You may not qualify if:
- Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair, or PFO closure
- Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
- Wolff-Parkinson-White syndrome
- Prior cardiac surgery (Redo)
- Class IV NYHA heart failure symptoms
- Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
- Documented MI within 6 weeks prior to study enrollment
- Need for emergent cardiac surgery (i.e. cardiogenic shock)
- Known carotid artery stenosis greater than 80%
- LA size greater than or equal to 8cm
- Current diagnosis of active systemic infection
- Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
- Pregnancy or desire to get pregnant within 12-months of the study enrollment
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- Renal failure requiring dialysis or hepatic failure
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AtriCure, Inc.lead
Study Sites (9)
Mercy Heart Institute
Sacramento, California, 95819, United States
Sutter Health
Sacramento, California, 95819, United States
Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Baylor Heart Hospital
Dallas, Texas, 75230, United States
Inova Fairfax
Falls Church, Virginia, 22042, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jim Lucky
- Organization
- AtriCure, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2007
First Posted
November 20, 2007
Study Start
November 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2012
Last Updated
March 29, 2013
Results First Posted
March 14, 2013
Record last verified: 2013-03