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

Phase 3

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Drug: Standard Anti-arrhythmic Drug (AAD) Therapy; Device: Endoscopic Ablation System

• Registration Number: NCT00477230
• Lead Sponsor: CardioFocus

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-05-21
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-23
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2012-06
• Results First Submitted: 2012-06-26
• Results First Submitted QC: 2012-06-26
• Last Update Submitted: 2012-06-26
• Results First Posted: 2012-06-27
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Standard Anti-arrhythmic Drug (AAD) Therapy	Medication
1	Endoscopic Ablation System	Single ablation procedure with Endoscopic Ablation System

Primary Outcome Measures

Name	Time	Method
Freedom for Symptomatic Episode of Atrial Fibrillation at One Year	One Year

Trial Locations

Locations (18)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Indiana University, Krannert Institute of Cardiology; 🇺🇸 Indianapolis, Indiana, United States

Strong Memorial Hosptial - University of Rochester; 🇺🇸 Rochester, New York, United States

Arizona Arrhythmia Consultants; 🇺🇸 Scottsdale, Arizona, United States

Florida Hospital; 🇺🇸 Orlando, Florida, United States

The Methodist Hospital; 🇺🇸 Houston, Texas, United States

Texas Cardiac Arrhythmia Research; 🇺🇸 Austin, Texas, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Genesis Medical Center; 🇺🇸 Davenport, Iowa, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Mercy General Hospital; 🇺🇸 Sacramento, California, United States

St. John's Health Center; 🇺🇸 Santa Monica, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

St. Luke's-Roosevelt; 🇺🇸 New York, New York, United States

Palm Beach Heart Research Institute; 🇺🇸 Atlantis, Florida, United States

Sentara Cardiovascular Research Institute; 🇺🇸 Norfolk, Virginia, United States