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NCT00971204 Clinical Trial

Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00971204
Other study ID # 25-2734
Secondary ID
Status Completed
Phase Phase 2
First received September 2, 2009
Last updated July 27, 2016
Start date September 2009
Est. completion date June 2012

Study information
Verified date July 2016
Source CardioFocus
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• CardioFocus HeartLight Endoscopic Ablation System
PVI ablation

Locations
Country Name City State
United States Texas Cardiac Arrhythmia Research Foundation Austin Texas
United States University of Alabama at Birmingham Birmingham Alabama
United States Medical University of South Carolina Charleston South Carolina
United States University Of Virginia Health System Charlottesville Virginia
United States The Methodist Hospital Research Institute Houston Texas
United States Mt. Sinai Hospital New York New York
United States Sentara Norfolk General Hospital Norfolk Virginia
United States University of Pennsylvania Health System Philadelphia Pennsylvania
United States William Beaumont Hospital Royal Oak Michigan
United States Pacific Heart Institute Santa Monica California

Sponsors (1)
Lead Sponsor Collaborator
CardioFocus

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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