A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation

Completed · Phase 3

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90 days after study therapy was initiated was considered a blanked period for all subjects.

Key facts

Study ID

NCT00523978

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

245

Starts

2006-10-01

Expected to finish

2011-07-01

Last updated by the study team

2018-10-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented Paroxysmal Atrial Fibrillation (PAF): PAF diagnosis, 2 episodes of PAF within the last 2 months, at least 1 episode of PAF must be documented
• Age 18-75
• Documented Effectiveness Failure of one (1) AF drug
• Willing to be randomized to either group and do full 12 month follow-up
• Able to follow standardized AF drug protocol

You may not qualify if…

• Any cardioversion within 3 months or more than 2 within 2 years
• Amiodarone within 6 months
• LA size > 5.0cm
• Previous LA ablation/surgery, structural heart disease, heart failure class III or IV
• Hypertrophic cardiomyopathy, Mitral prosthesis
• Unstable angina, uncontrolled hyperthyroidism
• Stroke or TIA within 6 months, MI within 2 months, cardiac surgery within 3 months
• Thrombocytosis, thrombocytopenia
• Any condition contraindicating chronic anticoagulation
• EF <40%
• Pregnancy
• Life expectancy <1year

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• Cedar Sinai Medical Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Stanford Hospital — Stanford, California, United States
• Colorado Cardiac Alliance -- Memorial Hospital — Colorado Springs, Colorado, United States
• Mayo Clinic- Jacksonville — Jacksonville, Florida, United States
• BayHeart Group -- St-Joseph's Hospital — Tampa, Florida, United States
• Emery Crawford Long Hospital — Atlanta, Georgia, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• New Mexico Heart Institute — Albuquerque, New Mexico, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania Health — Philadelphia, Pennsylvania, United States
• Baylor Heart and Vascular Hospital — Dallas, Texas, United States
• Inova Research Center — Falls Church, Virginia, United States
• Sentara CV Research Institute — Norfolk, Virginia, United States
• Medical College of Virginia — Richmond, Virginia, United States
• Cardiology Associates of Green Bay — Green Bay, Wisconsin, United States
• Arrhythmia Center of Southern WI — Milwaukee, Wisconsin, United States
• London Medical Health Sciences — London, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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