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

June 26, 2012 updated by: CardioFocus

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Arizona Arrhythmia Consultants
    • California
      • Sacramento, California, United States, 95819-3633
        • Mercy General Hospital
      • San Francisco, California, United States, 94143
        • University of California at San Francisco
      • Santa Monica, California, United States
        • St. John's Health Center
    • Florida
      • Atlantis, Florida, United States, 33462
        • Palm Beach Heart Research Institute
      • Orlando, Florida, United States
        • Florida Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University, Krannert Institute of Cardiology
    • Iowa
      • Davenport, Iowa, United States
        • Genesis Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Royal Oak, Michigan, United States
        • William Beaumont Hospital
    • New York
      • New York, New York, United States
        • St. Luke's-Roosevelt
      • Rochester, New York, United States, 14627
        • Strong Memorial Hosptial - University of Rochester
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19096
        • University of Pennsylvania Hospital
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
    • Virginia
      • Charlottesville, Virginia, United States
        • University of Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Cardiovascular Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom for Symptomatic Episode of Atrial Fibrillation at One Year
Time Frame: One Year
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioFocus

Investigators

  • Principal Investigator: Vivek Reddy, MD, University of Miami
  • Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia
  • Study Director: Burke Barrett, CardioFocus, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

May 21, 2007

First Submitted That Met QC Criteria

May 21, 2007

First Posted (Estimate)

May 23, 2007

Study Record Updates

Last Update Posted (Estimate)

June 27, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENABLE 25-2064

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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