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

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ClinicalTrials.gov Identifier: NCT01456000
Recruitment Status : Completed
First Posted : October 20, 2011
Results First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
CardioFocus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: EAS-AC (HeartLight) Procedure: Control Arm Ablation Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation
Study Start Date : January 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: EAS-AC (HeartLight)
Treatment with the EAS-AC.
Device: EAS-AC (HeartLight)
Pulmonary vien isolation
Active Comparator: Control Arm Ablation
Treatment with standard ablation.
Procedure: Control Arm Ablation
Treatment with standard ablation.



Primary Outcome Measures :
  1. Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description [ Time Frame: 1 year ]
    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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456000


  Show 21 Study Locations
Sponsors and Collaborators
CardioFocus
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT01456000     History of Changes
Other Study ID Numbers: 25-3002
First Posted: October 20, 2011    Key Record Dates
Results First Posted: September 8, 2016
Last Update Posted: September 8, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by CardioFocus:
atrial fibrillation
AF
PAF
PVI
ablation
paroxysmal atrial fibrillation
pulmonary vein isolation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes