CARTO® 3 System and Real Time Intracardiac Ultrasound

Completed

Conditions studied: Atrial Fibrillation, Paroxysmal AF

In brief

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).

Key facts

Study ID

NCT01716663

Run by

Biosense Webster, Inc.

People needed

234

Starts

2012-10-01

Expected to finish

2013-09-01

Last updated by the study team

2014-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AZ Heart Rhythm Research Center — Phoenix, Arizona, United States
• Scottsdale Healthcare Research Institute — Scottsdale, Arizona, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• JFK Medical Center — Atlantis, Florida, United States
• East Coast Institute for Research, LLC. St. Vincent's Ambulatory Care, Inc. — Jacksonville, Florida, United States
• Osceola Regional Medical Center — Kissimmee, Florida, United States
• Tallahassee Research Institute — Tallahassee, Florida, United States
• Pepin Heart Hospital — Tampa, Florida, United States
• Northeast Georgia Heart Center, PC — Gainsville, Georgia, United States
• Provena St. Joseph Medical Center — Joliet, Illinois, United States
• Washington Adventist Hospital CCVR — Takoma Park, Maryland, United States
• Michigan CardioVascular Institute — Saginaw, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Kettering Medical Center — Kettering, Ohio, United States
• St. Mary Medical Center — Newtown, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Geisinger Heart Institute — Wilkes-Barre, Pennsylvania, United States
• Lankenau Institute for Medical Research — Wynnewood, Pennsylvania, United States
• Wellmont CVA Heart Institute — Kingsport, Tennessee, United States
• The Methodist Hospital Research Institute — Houston, Texas, United States
• Northeast Baptist Hospital — San Antonio, Texas, United States
• Scott & White Memorial Hospital — Temple, Texas, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.