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Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) (HeartLight) in Patients With Paroxysmal Atrial Fibrillation (PAF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01456000
First received: October 17, 2011
Last updated: October 15, 2013
Last verified: October 2013

October 17, 2011
October 15, 2013
January 2012
October 2013   (final data collection date for primary outcome measure)
Freedom for documented, symptomatic atrial fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Episodes of AF will be monitored during the follow-up period and the rate of subjects with no documented, symptomatic episodes of AF in follow-up will be compared.
Not Provided
Complete list of historical versions of study NCT01456000 on ClinicalTrials.gov Archive Site
Not Provided
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Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) (HeartLight) in Patients With Paroxysmal Atrial Fibrillation (PAF)
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation

The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.

A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
  • Device: EAS-AC (HeartLight)
    Pulmonary vien isolation
  • Procedure: Control Arm Ablation
    Treatment with standard ablation.
  • Experimental: EAS-AC (HeartLight)
    Treatment with the EAS-AC.
    Intervention: Device: EAS-AC (HeartLight)
  • Active Comparator: Control Arm Ablation
    Treatment with standard ablation.
    Intervention: Procedure: Control Arm Ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
450
December 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 to 75 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 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01456000
25-3002
Yes
CardioFocus
CardioFocus
Not Provided
Study Director: Burke Barrett CardioFocus, Inc. (sponsor)
Principal Investigator: Vivek Reddy, MD Mt. Sinai Hospital, NYC
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
CardioFocus
October 2013

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