NAVISTAR® THERMOCOOL® SF Catheter: Observational Study

Completed

Conditions studied: Atrial Fibrillation, Paroxysmal Arrhythmia

In brief

This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

Key facts

Study ID

NCT01585961

Run by

Biosense Webster, Inc.

People needed

511

Starts

2012-04-01

Expected to finish

2014-07-01

Last updated by the study team

2015-01-26

Who can join

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

You may qualify if…

• Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation
• Age 18 years or older
• Patients must be able and willing to provide written informed consent to participate in the study

You may not qualify if…

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

Where it is running

• Heart Center Research, LLC — Huntsville, Alabama, United States
• Alaska Heart Institute, LLC — Anchorage, Alaska, United States
• Arizona Heart Hospital — Phoenix, Arizona, United States
• Scottsdale Healthcare Research Institute — Scottsdale, Arizona, United States
• Scripps Clinical Research — La Jolla, California, United States
• San Diego Cardiac Center — San Diego, California, United States
• UCSF Medical Center — San Francisco, California, United States
• JFK Medical Center — Atlantis, Florida, United States
• Florida Hospital Memorial Medical Center — Daytona Beach, Florida, United States
• St. Vincent's Ambulatory Care, Inc. — Jacksonville, Florida, United States
• Largo Medical Center — Largo, Florida, United States
• Florida Hospital - Orlando — Orlando, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• St. Joseph's Hospital of Atlanta — Atlanta, Georgia, United States
• Cardiology Associates of Savannah — Savannah, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Lutheran Medical Group, LLC — Fort Wayne, Indiana, United States
• University of Iowa Hospital & Clinics — Iowa City, Iowa, United States
• University of Kansas Hospitals — Kansas City, Kansas, United States
• Central Baptist Hospital — Lexington, Kentucky, United States
• Baptist Hospital — Louisville, Kentucky, United States
• Cardiovascular Research Foundation of Louisiana — Baton Rouge, Louisiana, United States
• Washington Adventist Hospital — Takoma Park, Maryland, 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.