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

NCT ID: NCT01196923

Last Updated: 2016-07-27

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

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to confirm the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.

Detailed Description

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Conditions

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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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HeartLight Ablation

Group Type EXPERIMENTAL

Endoscopically Guided Ablation

Intervention Type DEVICE

Visually Guided Ablation using EAS-AC

Interventions

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Endoscopically Guided Ablation

Visually Guided Ablation using EAS-AC

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic, Paroxysmal Atrial Fibrillation (AF)
* 18 to 70 Years of age
* Others

Exclusion Criteria

* Generally good overall health as determined by multiple criteria
* Willing to participate in a study
* Others
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 Barrett

Role: STUDY_DIRECTOR

CardioFocus

Locations

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Centro Cardiologico Monzino

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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25-2858

Identifier Type: -

Identifier Source: org_study_id

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