Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation

NCT ID: NCT00741611

Last Updated: 2012-10-26

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-11-30

Brief Summary

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This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs.

Detailed Description

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Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mesh

Ablation with HD Mesh Ablation System

Group Type EXPERIMENTAL

HD Mesh Ablation System

Intervention Type DEVICE

Ablation using the HD Mesh Ablation System

Drug

Treatment with anti-arrhythmic drugs

Group Type ACTIVE_COMPARATOR

Anti-arrhythmic drugs

Intervention Type DRUG

5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation

Interventions

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HD Mesh Ablation System

Ablation using the HD Mesh Ablation System

Intervention Type DEVICE

Anti-arrhythmic drugs

5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one class I or III anti-arrhythmic drug

Exclusion Criteria

* Previous surgical or catheter ablation to treat AF
* Permanent AF
* Uncontrolled or unstable medical conditions
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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C. R. Bard

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Marie Harcarik

Role: STUDY_DIRECTOR

C. R. Bard, Inc.

Locations

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University of California, San Diego Medical Center

San Diego, California, United States

Site Status

Aurora Denver Cardiology Associates

Aurora, Colorado, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

Florida Heart Group

Orlando, Florida, United States

Site Status

Bay Heart Group

Tampa, Florida, United States

Site Status

Piedmont Hospital Research Institute

Atlanta, Georgia, United States

Site Status

Northeast Cardiology Associates

Bangor, Maine, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Site Status

St. John's Medical Research Institute

Springfield, Missouri, United States

Site Status

Lehigh Valley Heart Specialists

Allentown, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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IDE # G070179

Identifier Type: -

Identifier Source: secondary_id

BEP-4408-2007

Identifier Type: -

Identifier Source: org_study_id