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

Completed · Phase 3

Conditions studied: Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT01639495

Run by

Biosense Webster, Inc.

People needed

148

Starts

2012-07-01

Expected to finish

2014-10-01

Last updated by the study team

2018-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 including, but not limited to:
• 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

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• Stanford University School of Medicine — Stanford, California, United States
• Florida Hospital — Orlando, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Loyola University Chicago — Maywood, Illinois, United States
• University of Kansas Hospitals — Kansas City, Kansas, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• University of Pennslyvania — Philadelphia, Pennsylvania, United States
• Texas Cardiac Arrhythmia Foundation — Austin, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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