Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
CardioFocus Identifier:
First received: September 2, 2009
Last updated: July 27, 2016
Last verified: July 2016
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: 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


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

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
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 identifier: NCT00971204

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
Study Director: Burke Barret CardioFocus, Inc.
  More Information

Responsible Party: CardioFocus Identifier: NCT00971204     History of Changes
Other Study ID Numbers: 25-2734
Study First Received: September 2, 2009
Results First Received: April 18, 2016
Last Updated: July 27, 2016

Keywords provided by CardioFocus:
atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on April 27, 2017