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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Ablation System
Standard Anti-arrhythmic Drug (AAD) Therapy
Sponsored by
CardioFocus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring AF, PAF, paroxysmal atrial fibrillation, ablation, failed drugs

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Arrhythmia Consultants
  • Mercy General Hospital
  • University of California at San Francisco
  • St. John's Health Center
  • Palm Beach Heart Research Institute
  • Florida Hospital
  • Indiana University, Krannert Institute of Cardiology
  • Genesis Medical Center
  • University of Michigan
  • William Beaumont Hospital
  • St. Luke's-Roosevelt
  • Strong Memorial Hosptial - University of Rochester
  • Ohio State University
  • University of Pennsylvania Hospital
  • Texas Cardiac Arrhythmia Research
  • The Methodist Hospital
  • University of Virginia
  • Sentara Cardiovascular Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Single ablation procedure with Endoscopic Ablation System

Medication

Outcomes

Primary Outcome Measures

Freedom for Symptomatic Episode of Atrial Fibrillation at One Year

Secondary Outcome Measures

Full Information

First Posted
May 21, 2007
Last Updated
June 26, 2012
Sponsor
CardioFocus
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1. Study Identification

Unique Protocol Identification Number
NCT00477230
Brief Title
Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs
Acronym
ENABLE
Official Title
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Study terminated based on decision of Sponsor.
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardioFocus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
AF, PAF, paroxysmal atrial fibrillation, ablation, failed drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Single ablation procedure with Endoscopic Ablation System
Arm Title
2
Arm Type
Active Comparator
Arm Description
Medication
Intervention Type
Device
Intervention Name(s)
Endoscopic Ablation System
Intervention Description
Single ablation procedure with Endoscopic Ablation System
Intervention Type
Drug
Intervention Name(s)
Standard Anti-arrhythmic Drug (AAD) Therapy
Intervention Description
Medication as prescribed by physician.
Primary Outcome Measure Information:
Title
Freedom for Symptomatic Episode of Atrial Fibrillation at One Year
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Burke Barrett
Organizational Affiliation
CardioFocus, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arrhythmia Consultants
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819-3633
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
St. John's Health Center
City
Santa Monica
State/Province
California
Country
United States
Facility Name
Palm Beach Heart Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Indiana University, Krannert Institute of Cardiology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Genesis Medical Center
City
Davenport
State/Province
Iowa
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
Country
United States
Facility Name
St. Luke's-Roosevelt
City
New York
State/Province
New York
Country
United States
Facility Name
Strong Memorial Hosptial - University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Sentara Cardiovascular Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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