A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation - Full Text View

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.

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

Drug Information available for: Propafenone hydrochloride Propafenone Flecainide Flecainide acetate Sotalol hydrochloride Sotalol

U.S. FDA Resources

Further study details as provided by CryoCath Technologies Inc.:

Primary Outcome Measures:

To evaluate the safety of treatment with the Arctic Front™ Cardiac CryoAblation Catheter System, including the FlexCath™ Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter, compared to a randomized drug control group, by assessing the [ Time Frame: After the last patient is enrolled and the 12-month follow-up is terminated. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the effectiveness of treatment with the Arctic Front™ Cardiac CryoAblation Catheter System, including the FlexCath™ Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter, compared to a randomized drug control group, by assess [ Time Frame: After the last patient is enrolled and the 12-month follow-up is terminated. ] [ Designated as safety issue: No ]

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

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Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523978

Show 21 Study Locations

Sponsors and Collaborators

CryoCath Technologies Inc.

Investigators

Principal Investigator:

Douglas L. Packer, MD

Mayo Clinic

More Information

No publications provided

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

Keywords provided by CryoCath Technologies Inc.:

Atrial Fibrillation

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 27, 2009