Clinical trial NCT00477230: Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs
Official title: Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: AF
PAF
paroxysmal atrial fibrillation
ablation
failed drugs
Lead sponsor: CardioFocus
Sponsor class: INDUSTRY
First posted: 2007-05-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Freedom for Symptomatic Episode of Atrial Fibrillation at One Year
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Santa Monica
country: United States
facility: St. John's Health Center
state: California
city: Atlantis
country: United States
facility: Palm Beach Heart Research Institute
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Indianapolis
country: United States
facility: Indiana University, Krannert Institute of Cardiology
state: Indiana
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: New York
country: United States
facility: St. Luke's-Roosevelt
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hosptial - University of Rochester
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
Study officials:
affiliation: University of Miami
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Cardiac Arrhythmia
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CardioFocus, Inc.
name: Burke Barrett
role: STUDY_DIRECTOR
References: