Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01196923
First received: September 7, 2010
Last updated: June 16, 2016
Last verified: June 2016

September 7, 2010
June 16, 2016
September 2010
March 2012   (final data collection date for primary outcome measure)
Acute Isolation of Pulmonary Veins. [ Time Frame: Acute PVI measured on the day of treatment ] [ Designated as safety issue: No ]
99% of pulmonary veins were isolated (72/73)
To determine the EAS-AC treatment success rate defined as the freedom from documented atrial fibrillation symptoms during the 12-month evaluation period. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01196923 on ClinicalTrials.gov Archive Site
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Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
The purpose of this study is to confirm the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
Device: Endoscopically Guided Ablation
Visually Guided Ablation using EAS-AC
Experimental: HeartLight Ablation
Intervention: Device: Endoscopically Guided Ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptomatic, Paroxysmal Atrial Fibrillation (AF)
  • 18 to 70 Years of age
  • Others

Exclusion Criteria:

  • Generally good overall health as determined by multiple criteria
  • Willing to participate in a study
  • Others
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01196923
25-2858
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CardioFocus
CardioFocus
Not Provided
Study Director: Burke Barrett CardioFocus
CardioFocus
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP