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CARTO® 3 System and Real Time Intracardiac Ultrasound

NCT ID: NCT01716663

Last Updated: 2014-12-01

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

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-09-30

Brief Summary

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This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).

Detailed Description

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This study is purposed to measure "real world" acute procedural outcomes (procedural efficiency and acute safety) associated with use of the CARTO® 3 System and real time intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent symptomatic paroxysmal AF.

Conditions

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Atrial Fibrillation Paroxysmal AF

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental: Catheter Ablation

These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.

Catheter Ablation

Intervention Type DEVICE

NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)

Interventions

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Catheter Ablation

NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)

Intervention Type DEVICE

Other Intervention Names

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CARTO® 3 System and Real Time Intracardiac Ultrasound

Eligibility Criteria

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Inclusion Criteria

* Drug refractory, recurrent symptomatic paroxysmal AF
* Age 18 years or older
* Patients able and willing to provide written informed consent to participate in the study and comply with study requirements

Exclusion Criteria

* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Previous ablation for atrial fibrillation
* AF episodes that last longer than 30 days
* Uncontrolled heart failure, or NYHA Class III or IV heart failure
* Documented intra-atrial thrombus or other abnormality on pre-ablation imaging
* Contraindication to anticoagulation
* Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
* Awaiting cardiac transplantation
* Heart disease for which corrective surgery is anticipated within 6 months
* Enrollment in other investigational drug or device study
* Subjects unwilling to comply with protocol or follow-up requirements
* Patients who are pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biosense Webster, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Usman Siddiqui, MD

Role: PRINCIPAL_INVESTIGATOR

Osceola Regional Medical Center

Mathew Hutchinson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Andy Tran, MD

Role: PRINCIPAL_INVESTIGATOR

Scottsdale Healthcare Research

Saumil Oza, MD

Role: PRINCIPAL_INVESTIGATOR

East Coast Institute for Research LLC, St. Vincent's Ambulatory Care, Inc.

Robert Fishel, MD

Role: PRINCIPAL_INVESTIGATOR

JFK Medical Center

Vijendra Swarup, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Heart Rhythm Research Center

Mohit Rastogi, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Adventist Hospital CCVR

Brett Gidney, MD

Role: PRINCIPAL_INVESTIGATOR

Santa Barbara Cottage Hospital

John Scherschel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Dilip Mathew, MD

Role: PRINCIPAL_INVESTIGATOR

Pepin Heart Hospital

William Sauer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Marcie Berger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Khawaja Baig, MD

Role: PRINCIPAL_INVESTIGATOR

Kettering Medical Center

Farhat Khairallah, MD

Role: PRINCIPAL_INVESTIGATOR

Tallahassee Research Institute

David Fitzgerald, MD

Role: PRINCIPAL_INVESTIGATOR

Scott & White Memorial Hospital

Gopi Dandamudi, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Heart Institute

Ahmad Abdul-Karim, MD

Role: PRINCIPAL_INVESTIGATOR

Provena St. Joseph Medical Center

Douglas Esberg, MD

Role: PRINCIPAL_INVESTIGATOR

Main Line Health

Scott Burke, MD

Role: PRINCIPAL_INVESTIGATOR

St. Mary's Medical Center

Gregory Jones, MD

Role: PRINCIPAL_INVESTIGATOR

Wellmont CVA Heart Institute

Tapan Rami, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Salem Sayar, MD

Role: PRINCIPAL_INVESTIGATOR

Northeast Georgia Heart Center, PC

Gunjan Shukla, MD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Philip Gentlesk, MD

Role: PRINCIPAL_INVESTIGATOR

Sentara Norfolk General Hospital

Asim Yunus, MD

Role: PRINCIPAL_INVESTIGATOR

Michigan CardioVascular Institute

Scott Reich, MD

Role: PRINCIPAL_INVESTIGATOR

Northeast Baptist Hospital

Locations

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AZ Heart Rhythm Research Center

Phoenix, Arizona, United States

Site Status

Scottsdale Healthcare Research Institute

Scottsdale, Arizona, United States

Site Status

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Site Status

University of Colorado Denver

Aurora, Colorado, United States

Site Status

JFK Medical Center

Atlantis, Florida, United States

Site Status

East Coast Institute for Research, LLC. St. Vincent's Ambulatory Care, Inc.

Jacksonville, Florida, United States

Site Status

Osceola Regional Medical Center

Kissimmee, Florida, United States

Site Status

Tallahassee Research Institute

Tallahassee, Florida, United States

Site Status

Pepin Heart Hospital

Tampa, Florida, United States

Site Status

Northeast Georgia Heart Center, PC

Gainsville, Georgia, United States

Site Status

Provena St. Joseph Medical Center

Joliet, Illinois, United States

Site Status

Washington Adventist Hospital CCVR

Takoma Park, Maryland, United States

Site Status

Michigan CardioVascular Institute

Saginaw, Michigan, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Kettering Medical Center

Kettering, Ohio, United States

Site Status

St. Mary Medical Center

Newtown, Pennsylvania, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Geisinger Heart Institute

Wilkes-Barre, Pennsylvania, United States

Site Status

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

Site Status

Wellmont CVA Heart Institute

Kingsport, Tennessee, United States

Site Status

The Methodist Hospital Research Institute

Houston, Texas, United States

Site Status

Northeast Baptist Hospital

San Antonio, Texas, United States

Site Status

Scott & White Memorial Hospital

Temple, Texas, United States

Site Status

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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IUAF

Identifier Type: -

Identifier Source: org_study_id