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| Sponsor: | CryoCath Technologies Inc. |
|---|---|
| Information provided by: | CryoCath Technologies Inc. |
| ClinicalTrials.gov Identifier: | NCT00523978 |
Purpose
PS-023 is a randomized controlled clinical study. The purpose of this study is to determine whether this new catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable Sheath) is safe and effective for the treatment of paroxysmal atrial fibrillation, as well as to see if this treatment is better compared to a medication. This catheter system uses freezing energy, cryoablation, to ablate (destroy) abnormal tissue in or near the pulmonary veins. A refrigerant (cooling material) is delivered within the catheter to cool the catheter tip. This freezes and destroys the cells at the entrance to the pulmonary veins. If the atrial fibrillation comes from somewhere else in the heart, another catheter, the Freezor MAX, will be used to freeze that area. This experimental catheter also uses freezing to ablate abnormal tissue. Many atrial fibrillation patients also have another arrhythmia called atrial flutter. In order to treat or to prevent atrial flutter after the procedure, the Freezor MAX catheter may be used to freeze the cells in the area of the heart where atrial flutter starts.
| Condition | Intervention | Phase |
|---|---|---|
|
Paroxysmal Atrial Fibrillation |
Device: Arctic Front Cryoablation Catheter Drug: Flecainide or Sotalol or Propafenone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Controlled Clinical Trial of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation. |
| Estimated Enrollment: | 243 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental
an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.
|
Device: Arctic Front Cryoablation Catheter
an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.
|
|
Control: Active Comparator
a control group receiving only an Atrial Fibrillation Drug
|
Drug: Flecainide or Sotalol or Propafenone
Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35294-0007 | |
| United States, California | |
| Cedar Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Stanford Hospital | |
| Stanford, California, United States, 94305-5233 | |
| UC Davis Medical Center | |
| Sacramento, California, United States, 98517 | |
| United States, Colorado | |
| Colorado Cardiac Alliance -- Memorial Hospital | |
| Colorado Springs, Colorado, United States, 80907 | |
| United States, Florida | |
| BayHeart Group -- St-Joseph's Hospital | |
| Tampa, Florida, United States, 33607 | |
| United States, Georgia | |
| Piedmont Hospital | |
| Atlanta, Georgia, United States, 30309 | |
| Emery Crawford Long Hospital | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Iowa | |
| Iowa Heart Center | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55902 | |
| United States, New Mexico | |
| New Mexico Heart Institute | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| University of Pennsylvania Health | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| United States, Texas | |
| Baylor Heart and Vascular Hospital | |
| Dallas, Texas, United States, 75226 | |
| United States, Virginia | |
| Inova Research Center | |
| Falls Church, Virginia, United States, 22042 | |
| Medical College of Virginia | |
| Richmond, Virginia, United States, 23219 | |
| United States, Wisconsin | |
| Cardiology Associates of Green Bay | |
| Green Bay, Wisconsin, United States, 54301-3596 | |
| Arrhythmia Center of Southern WI | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Canada, Quebec | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Principal Investigator: | Douglas L. Packer, MD | Mayo Clinic |
More Information
| Responsible Party: | CryoCath Technologies Inc. ( Patrick Chauvet ) |
| Study ID Numbers: | PS-023 |
| Study First Received: | August 31, 2007 |
| Last Updated: | January 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00523978 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Atrial Fibrillation |
|
Sympatholytics Neurotransmitter Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Cardiovascular Agents Pharmacologic Actions Sotalol Pathologic Processes Propafenone |
Autonomic Agents Therapeutic Uses Flecainide Adrenergic beta-Antagonists Adrenergic Antagonists Cardiovascular Diseases Peripheral Nervous System Agents Atrial Fibrillation Anti-Arrhythmia Agents Arrhythmias, Cardiac |
