Tailored Treatment of Permanent Atrial Fibrillation - Full Text View

Sponsor:	Ablation Frontiers
Information provided by:	Ablation Frontiers
ClinicalTrials.gov Identifier:	NCT00514735

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Procedure: Ablation Frontiers Cardiac Ablation System (Arm 1- Experimental); DC Cardioversions (Arm 2- Active Comparator)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Tailored Treatment of Permanent Atrial Fibrillation - TTOP AF

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Ablation Frontiers:

Primary Outcome Measures:

Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ablation Management	Procedure: Ablation Frontiers Cardiac Ablation System (Arm 1- Experimental); DC Cardioversions (Arm 2- Active Comparator) Ablation procedures and/or DC Cardioversions
2: Active Comparator Medical Management	Procedure: Ablation Frontiers Cardiac Ablation System (Arm 1- Experimental); DC Cardioversions (Arm 2- Active Comparator) Ablation procedures and/or DC Cardioversions

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514735

Show 24 Study Locations

Sponsors and Collaborators

Ablation Frontiers

More Information

Additional Information:

Company website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ablation Frontiers, Inc. ( Jerald Cox, Director of Clinical Affairs )
Study ID Numbers:	AFI-30
Study First Received:	August 8, 2007
Last Updated:	May 22, 2009
ClinicalTrials.gov Identifier:	NCT00514735 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ablation Frontiers:

atrial fibrillation

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010