Tailored Treatment of Permanent Atrial Fibrillation - Tabular View

Tracking Information
First Received Date ^ICMJE	August 8, 2007
Last Updated Date	May 22, 2009
Start Date ^ICMJE	May 2007
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 6, 2008)	Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00514735 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 6, 2008)	Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Tailored Treatment of Permanent Atrial Fibrillation
Official Title ^ICMJE	Tailored Treatment of Permanent Atrial Fibrillation - TTOP AF
Brief Summary	The purpose of the trial is to evaluate the safety and efficacy of the Ablation Frontiers Cardiac Ablation System compared to currently approved treatment options for atrial fibrillation.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Condition ^ICMJE	Atrial Fibrillation
Intervention ^ICMJE	Procedure: Ablation Frontiers Cardiac Ablation System (Arm 1- Experimental); DC Cardioversions (Arm 2- Active Comparator)
Study Arms / Comparison Groups	Experimental: Ablation Management Active Comparator: Medical Management
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	210
Estimated Completion Date	December 2009
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: History of symptomatic atrial fibrillation Age between 18 and 70 Failure of at least one class I or III rhythm control AAD Willingness, ability and commitment to participate in baseline and follow- up evaluations for the full length of the study
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Netherlands

Administrative Information
NCT ID ^ICMJE	NCT00514735
Responsible Party	Jerald Cox, Director of Clinical Affairs, Ablation Frontiers, Inc.
Study ID Numbers ^ICMJE	AFI-30
Study Sponsor ^ICMJE	Ablation Frontiers
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Ablation Frontiers
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP