Back to resultsClinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CardioFocus HeartLight Endoscopic Ablation System
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring atrial fibrillation, PAF
Eligibility Criteria
Inclusion Criteria:
- 18 to 70 years
- paroxysmal atrial fibrillation
- failure of at least one AAD
- others
Exclusion Criteria:
- overall good health as established by multiple criteria
Sites / Locations
- University of Alabama at Birmingham
- Pacific Heart Institute
- William Beaumont Hospital
- Mt. Sinai Hospital
- University of Pennsylvania Health System
- Medical University of South Carolina
- Texas Cardiac Arrhythmia Research Foundation
- The Methodist Hospital Research Institute
- University Of Virginia Health System
- Sentara Norfolk General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with HeartLight System
Arm Description
Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System
Outcomes
Primary Outcome Measures
Freedom From Recurrence of Atrial Fibrillation
Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00971204
Brief Title
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Official Title
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (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
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
atrial fibrillation, PAF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with HeartLight System
Arm Type
Experimental
Arm Description
Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System
Intervention Type
Device
Intervention Name(s)
CardioFocus HeartLight Endoscopic Ablation System
Intervention Description
PVI ablation
Primary Outcome Measure Information:
Title
Freedom From Recurrence of Atrial Fibrillation
Description
Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 70 years
paroxysmal atrial fibrillation
failure of at least one AAD
others
Exclusion Criteria:
overall good health as established by multiple criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burke Barret
Organizational Affiliation
CardioFocus, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pacific Heart Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Facility Name
Mt. Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
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