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Sponsored by: |
CryoCath Technologies Inc. |
Information provided by: | CryoCath Technologies Inc. |
ClinicalTrials.gov Identifier: | NCT00523978 |
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 |
Genetics Home Reference related topics: | Brugada syndrome familial atrial fibrillation short QT syndrome |
MedlinePlus related topics: | Arrhythmia |
ChemIDplus related topics: | Propafenone Flecainide Sotalol Sotalol hydrochloride Propafenone hydrochloride Flecainide acetate |
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.
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Device: Arctic Front Cryoablation Catheter
an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.
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Control: Active Comparator
a control group receiving only an Atrial Fibrillation Drug
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Drug: Flecainide or Sotalol or Propafenone
Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day
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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 22 Study Locations |
CryoCath Technologies Inc. |
Principal Investigator: | Douglas L. Packer, MD | Mayo Clinic |
Responsible Party: | CryoCath Technologies Inc. ( Patrick Chauvet ) |
Study ID Numbers: | PS-023 |
First Received: | August 31, 2007 |
Last Updated: | February 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00523978 |
Health Authority: | United States: Food and Drug Administration |
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