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
  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:
  • 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: December 2014
Primary Completion Date: October 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
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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama, Birmingham
Birminham, Alabama, United States
United States, California
Stanford Hospital
Palo Alto, California, United States, 94305
Regional Cardiology Associates, Mercy General Hospital
Sacramento, California, United States, 95819
UCSF
San Francisco, California, United States, 94143
Pacific Heart Institute
Santa Monica, California, United States, 90404
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224-1865
United States, Illinois
Prairie Heart Institute
Springfield, Illinois, United States, 62701
United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Beaumont Hospital
Royal Oak, Michigan, United States, 48072
United States, Minnesota
Mayo Clinic Rochester/St. Mary's Hospital
Rochester, Minnesota, United States, 55902
United States, New York
Mt. Sinai Hospital
NY, New York, United States, 10029
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Murray, Utah, United States
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507
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: October 15, 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 August 28, 2014