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

NCT ID: NCT00971204

Last Updated: 2016-08-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with HeartLight System

Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System

Group Type EXPERIMENTAL

CardioFocus HeartLight Endoscopic Ablation System

Intervention Type DEVICE

PVI ablation

Interventions

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CardioFocus HeartLight Endoscopic Ablation System

PVI ablation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioFocus

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Burke Barret

Role: STUDY_DIRECTOR

CardioFocus, Inc.

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Pacific Heart Institute

Santa Monica, California, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Mt. Sinai Hospital

New York, New York, United States

Site Status

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Site Status

The Methodist Hospital Research Institute

Houston, Texas, United States

Site Status

University Of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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25-2734

Identifier Type: -

Identifier Source: org_study_id

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