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HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF) (HeartLight)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01456000
First received: October 17, 2011
Last updated: July 25, 2016
Last verified: July 2016

October 17, 2011
July 25, 2016
January 2012
December 2014   (final data collection date for primary outcome measure)
Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure.
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Complete list of historical versions of study NCT01456000 on ClinicalTrials.gov Archive Site
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HeartLight Ablation 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
Dukkipati SR, Cuoco F, Kutinsky I, Aryana A, Bahnson TD, Lakkireddy D, Woollett I, Issa ZF, Natale A, Reddy VY; HeartLight Study Investigators.. Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation. J Am Coll Cardiol. 2015 Sep 22;66(12):1350-60. doi: 10.1016/j.jacc.2015.07.036.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
405
January 2016
December 2014   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01456000
25-3002
Yes
No
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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
July 2016

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