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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 currently recruiting participants.
Verified April 2013 by CardioFocus
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01456000
First received: October 17, 2011
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by CardioFocus:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 450
Study Start Date: January 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456000

Contacts
Contact: Burke T Barrett 508-658-7200 bbarrett@cardiofocus.com

  Show 24 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

No publications provided

Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT01456000     History of Changes
Other Study ID Numbers: 25-3002
Study First Received: October 17, 2011
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

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 May 23, 2013