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Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs (ENABLE)

This study has been terminated.
(Study terminated based on decision of Sponsor.)
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT00477230
First received: May 21, 2007
Last updated: June 26, 2012
Last verified: June 2012

May 21, 2007
June 26, 2012
March 2007
May 2009   (final data collection date for primary outcome measure)
Freedom for Symptomatic Episode of Atrial Fibrillation at One Year [ Time Frame: One Year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00477230 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)

The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are:

  • A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter
  • Standard drug therapy (antiarrhythmic drugs)

To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you.

Eligibility Criteria

Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include:

  • 18 to 80 years of age
  • Frequent episodes of AF
  • Failed at least 1 drug treatment for AF (beta-blockers or standard AADs)
  • Other criteria
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • Device: Endoscopic Ablation System
    Single ablation procedure with Endoscopic Ablation System
  • Drug: Standard Anti-arrhythmic Drug (AAD) Therapy
    Medication as prescribed by physician.
  • Experimental: 1
    Single ablation procedure with Endoscopic Ablation System
    Intervention: Device: Endoscopic Ablation System
  • Active Comparator: 2
    Medication
    Intervention: Drug: Standard Anti-arrhythmic Drug (AAD) Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
64
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 to 80 years old
  • Paroxysmal atrial fibrillation (AF)
  • Frequent episodes of AF
  • Failed at least 1 drug treatment
  • Others

Exclusion Criteria:

  • Others
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00477230
ENABLE 25-2064
Yes
CardioFocus
CardioFocus
Not Provided
Principal Investigator: Vivek Reddy, MD University of Miami
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia
Study Director: Burke Barrett CardioFocus, Inc.
CardioFocus
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP