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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT00971204
First received: September 2, 2009
Last updated: July 27, 2016
Last verified: July 2016

September 2, 2009
July 27, 2016
September 2009
December 2011   (final data collection date for primary outcome measure)
Freedom From Recurrence of Atrial Fibrillation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.
Recurrence of atrial fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00971204 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
Device: CardioFocus HeartLight Endoscopic Ablation System
PVI ablation
Experimental: Treatment with HeartLight System
Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System
Intervention: Device: CardioFocus HeartLight Endoscopic Ablation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 to 70 years
  • paroxysmal atrial fibrillation
  • failure of at least one AAD
  • others

Exclusion Criteria:

  • overall good health as established by multiple criteria
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00971204
25-2734
Yes
Not Provided
Not Provided
CardioFocus
CardioFocus
Not Provided
Study Director: Burke Barret CardioFocus, Inc.
CardioFocus
July 2016

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