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Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971204
First Posted: September 3, 2009
Last Update Posted: August 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CardioFocus
  Purpose
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.

Condition Intervention Phase
Paroxysmal Atrial Fibrillation Device: CardioFocus HeartLight Endoscopic Ablation System Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by CardioFocus:

Primary Outcome Measures:
  • Freedom From Recurrence of Atrial Fibrillation [ Time Frame: 12 months ]
    Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.


Enrollment: 100
Study Start Date: September 2009
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with HeartLight System
Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System
Device: CardioFocus HeartLight Endoscopic Ablation System
PVI ablation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 70 years
  • paroxysmal atrial fibrillation
  • failure of at least one AAD
  • others

Exclusion Criteria:

  • overall good health as established by multiple criteria
  Contacts and Locations
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): NCT00971204


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Pacific Heart Institute
Santa Monica, California, United States, 90404
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48072
United States, New York
Mt. Sinai Hospital
New York, New York, United States, 10029
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
United States, Virginia
University Of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
CardioFocus
Investigators
Study Director: Burke Barret CardioFocus, Inc.
  More Information

Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT00971204     History of Changes
Other Study ID Numbers: 25-2734
First Submitted: September 2, 2009
First Posted: September 3, 2009
Results First Submitted: April 18, 2016
Results First Posted: July 27, 2016
Last Update Posted: August 1, 2016
Last Verified: July 2016

Keywords provided by CardioFocus:
atrial fibrillation
PAF

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