Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
1 other identifier
interventional
100
1 country
10
Brief Summary
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2009
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
July 27, 2016
CompletedAugust 1, 2016
July 1, 2016
2.2 years
September 2, 2009
April 18, 2016
July 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Study Arms (1)
Treatment with HeartLight System
EXPERIMENTALTreatment of paroxysmal atrial fibrillation (PAF) with HeartLight System
Interventions
Eligibility Criteria
You may qualify if:
- to 70 years
- paroxysmal atrial fibrillation
- failure of at least one AAD
- others
You may not qualify if:
- overall good health as established by multiple criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioFocuslead
Study Sites (10)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Pacific Heart Institute
Santa Monica, California, 90404, United States
William Beaumont Hospital
Royal Oak, Michigan, 48072, United States
Mt. Sinai Hospital
New York, New York, 10029, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
University Of Virginia Health System
Charlottesville, Virginia, 22908, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Burke Barrett, VP Regulatory & Clinical Affairs
- Organization
- CardioFocus, Inc.
Study Officials
- STUDY DIRECTOR
Burke Barret
CardioFocus, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2009
First Posted
September 3, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2011
Study Completion
June 1, 2012
Last Updated
August 1, 2016
Results First Posted
July 27, 2016
Record last verified: 2016-07