Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00477230
Recruitment Status : Terminated (Study terminated based on decision of Sponsor.)
First Posted : May 23, 2007
Results First Posted : June 27, 2012
Last Update Posted : June 27, 2012
Sponsor:
Information provided by (Responsible Party):
CardioFocus

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Endoscopic Ablation System Drug: Standard Anti-arrhythmic Drug (AAD) Therapy Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)
Study Start Date : March 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1
Single ablation procedure with Endoscopic Ablation System
 Device: Endoscopic Ablation System
Single ablation procedure with Endoscopic Ablation System
Active Comparator: 2
Medication
 Drug: Standard Anti-arrhythmic Drug (AAD) Therapy
Medication as prescribed by physician.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Freedom for Symptomatic Episode of Atrial Fibrillation at One Year [ Time Frame: One Year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00477230


Locations
Show Show 18 study locations
Sponsors and Collaborators
CardioFocus
Investigators
Layout table for investigator information
Principal Investigator: Vivek Reddy, MD University of Miami
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia
Study Director: Burke Barrett CardioFocus, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT00477230    
Other Study ID Numbers: ENABLE 25-2064
First Posted: May 23, 2007    Key Record Dates
Results First Posted: June 27, 2012
Last Update Posted: June 27, 2012
Last Verified: June 2012
Keywords provided by CardioFocus:
AF
PAF
paroxysmal atrial fibrillation
ablation
failed drugs
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents