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

Atrial Fibrillation Clinical Trial

— ENABLE  

Official title:

Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00477230
• Other study ID #: ENABLE 25-2064
• Status: Terminated
• Phase: Phase 3
• First received: May 21, 2007
• Last updated: June 26, 2012
• Start date: March 2007
• Est. completion date: May 2009

Study information

• Verified date: June 2012
• Source: CardioFocus
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Endoscopic Ablation System
Single ablation procedure with Endoscopic Ablation System

Drug:
• Standard Anti-arrhythmic Drug (AAD) Therapy
Medication as prescribed by physician.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Palm Beach Heart Research Institute	Atlantis	Florida
United States	Texas Cardiac Arrhythmia Research	Austin	Texas
United States	University of Virginia	Charlottesville	Virginia
United States	Ohio State University	Columbus	Ohio
United States	Genesis Medical Center	Davenport	Iowa
United States	The Methodist Hospital	Houston	Texas
United States	Indiana University, Krannert Institute of Cardiology	Indianapolis	Indiana
United States	St. Luke's-Roosevelt	New York	New York
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	Florida Hospital	Orlando	Florida
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Strong Memorial Hosptial - University of Rochester	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	University of California at San Francisco	San Francisco	California
United States	St. John's Health Center	Santa Monica	California
United States	Arizona Arrhythmia Consultants	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
CardioFocus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom for Symptomatic Episode of Atrial Fibrillation at One Year		One Year	No