ABLATE
AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
Sponsor study identifier
interventional
55
1 country
9
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
November 19, 2007
Actual (reported)November 20, 2007
Actual (reported)December 2009
Actual (reported)December 2012
Actual (reported)March 14, 2013
Actual (reported)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
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
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
55 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2007
First Posted
November 20, 2007
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Tailored Treatment of Permanent Atrial Fibrillation
Contact the study team to confirm eligibility.
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
Primary Completion
December 2009
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
March 29, 2013
Results First Posted
March 14, 2013
Record last verified: 2013-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: