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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
  Purpose
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 Intervention Phase
Paroxysmal Atrial Fibrillation
Device: EAS-AC (HeartLight)
Procedure: Control Arm Ablation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by CardioFocus:

Primary Outcome Measures:
  • 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.


Enrollment: 405
Study Start Date: January 2012
Study Completion Date: January 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: October 17, 2011
Results First Received: April 18, 2016
Last Updated: July 25, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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

ClinicalTrials.gov processed this record on September 29, 2016