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

NCT00477230 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2012-06-27

Study results available
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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

Conditions

Interventions

DEVICE

Endoscopic Ablation System

Single ablation procedure with Endoscopic Ablation System

DRUG

Standard Anti-arrhythmic Drug (AAD) Therapy

Medication as prescribed by physician.

Sponsors & Collaborators

  • CardioFocus

    lead INDUSTRY

Principal Investigators

  • Vivek Reddy, MD · University of Miami

  • Andrea Natale, MD · Texas Cardiac Arrhythmia

  • Burke Barrett · CardioFocus, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00477230 on ClinicalTrials.gov