Safety and Efficacy of CryoCor™ Cryoablation for PAF

NCT ID: NCT00231296

Last Updated: 2017-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2009-03-31

Brief Summary

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A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF

Detailed Description

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The purpose of this prospective, randomized multi-center clinical study is to establish the benefits of the CryoCor(TM) Cardiac Cryoablation System for treating symptomatic paroxysmal atrial fibrillation (PAF) in comparison to treatment with anti-arrhythmic medications alone. This study also evaluates the safety profile of the CryoCor(TM) Cardiac Cryoablation System when used in this same setting.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with CryoCor Cryoablation System

Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.

Group Type ACTIVE_COMPARATOR

Cardiac CryoCor Cryoablation System

Intervention Type DEVICE

Treatment with CryoCor Cardiac Cryoablation system

Treatment with standard medical therapy

Intervention includes treatment with ant-arrhythmic medications alone.

Group Type ACTIVE_COMPARATOR

Medical management

Intervention Type DRUG

Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications

Interventions

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Cardiac CryoCor Cryoablation System

Treatment with CryoCor Cardiac Cryoablation system

Intervention Type DEVICE

Medical management

Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications

Intervention Type DRUG

Other Intervention Names

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Ablation with the CryoCor ablation catheter AAD treatment

Eligibility Criteria

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Inclusion Criteria

* At least 3 episodes of PAF within 6 months
* Refractory to at least one drug
* Therapeutic anticoagulation
* Signed informed consent

Exclusion Criteria

* Persistent AF
* Structural heart disease
* Prior ablation
* Contraindication present
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Feld, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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Regional Cardiology Associates

Sacramento, California, United States

Site Status

UCSD Medical Center

San Diego, California, United States

Site Status

UCSF Medical

San Francisco, California, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

University of Chicago Hospitals

Chicago, Illinois, United States

Site Status

Carle Heart Center

Urbana, Illinois, United States

Site Status

Genesis Health

Davenport, Iowa, United States

Site Status

Iowa Heart Center

Des Moines, Iowa, United States

Site Status

Cardiology Associates of Kentucky

Lexington, Kentucky, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Site Status

St. Luke's-Roosevelt Hospital Center

New York, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Penn State Heart and Vascular Institute

Hershey, Pennsylvania, United States

Site Status

Drexel University

Philadelphia, Pennsylvania, United States

Site Status

Austin Heart, PA

Austin, Texas, United States

Site Status

Methodist Debakey Heart Center

Houston, Texas, United States

Site Status

Tacoma General

Tacoma, Washington, United States

Site Status

Heart Care Associates

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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GL-AF-02

Identifier Type: -

Identifier Source: org_study_id

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