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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:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT00971204
First received: September 2, 2009
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  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 Endoscopic Ablation System - Adaptive Contact (EAS-AC)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by CardioFocus:

Primary Outcome Measures:
  • Recurrence of atrial fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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 EAS-AC
Treatment of PAF with EAS-AC
 Device: CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC)
PVI ablation

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT00971204     History of Changes
Other Study ID Numbers: 25-2734
Study First Received: September 2, 2009
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by CardioFocus:
atrial fibrillation
PAF

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

ClinicalTrials.gov processed this record on May 23, 2013