THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS

NCT ID: NCT01639495

Last Updated: 2018-05-15

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

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-01

Study Completion Date

2014-10-01

Brief Summary

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This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.

Detailed Description

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The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.

Conditions

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Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study had a single arm: catheter ablation for PAF
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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THERMOCOOL® SMARTTOUCH™ Catheter

Group Type EXPERIMENTAL

THERMOCOOL® SMARTTOUCH™ Catheter

Intervention Type DEVICE

AF Ablation

Interventions

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THERMOCOOL® SMARTTOUCH™ Catheter

AF Ablation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have had at least 3 atrial fibrillation episodes within 6 months of this study
* Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
* 18 years of age or older

Exclusion Criteria

* Have had previous ablation for atrial fibrillation
* Have take amiodarone within 6 months of this study
* Have had any heart surgery within the last 60 days
* Have had a heart attack within the last 60 days
* Females who are pregnant or breast feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosense Webster, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama, Birmingham

Birmingham, Alabama, United States

Site Status

Stanford University School of Medicine

Stanford, California, United States

Site Status

Florida Hospital

Orlando, Florida, United States

Site Status

Piedmont Heart Institute

Atlanta, Georgia, United States

Site Status

Loyola University Chicago

Maywood, Illinois, United States

Site Status

University of Kansas Hospitals

Kansas City, Kansas, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

The Valley Hospital

Ridgewood, New Jersey, United States

Site Status

Mt. Sinai School of Medicine

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

University of Pennslyvania

Philadelphia, Pennsylvania, United States

Site Status

Texas Cardiac Arrhythmia Foundation

Austin, Texas, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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SMART-AF CA

Identifier Type: -

Identifier Source: org_study_id

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