CARTO® 3 System and Real Time Intracardiac Ultrasound



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/1/2014
Start Date:October 2012
End Date:October 2013
Contact:Timothy Hentges
Email:thentges@its.jnj.com
Phone:623-326-4343

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CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study

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).

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.

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
We found this trial at
19
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Phoenix, Arizona 85282
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Atlantis, Florida 33462
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Cincinnati, Ohio 45212
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Colorado Springs, Colorado 80907
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Danville, Pennsylvania 17822
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Joliet, Illinois 60435
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Kingsport, Tennessee 37660
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Langhorne, Pennsylvania 19047
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Los Angeles, California 90017
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Ogden, Utah
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Philadelphia, Pennsylvania 19114
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Phoenix, Arizona 85006
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Santa Barbara, California 93105
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Tallahassee, Florida 32308
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2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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Wynnewood, Pennsylvania 19096
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