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

Sponsor:	Medtronic Atrial Fibrillation Solutions
Collaborator:	Medtronic
Information provided by:	Medtronic Atrial Fibrillation Solutions
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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 Medtronic Atrial Fibrillation Solutions:

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 ]

Enrollment:	245
Study Start Date:	October 2006
Study Completion Date:	July 2011
Primary Completion Date:	August 2010 (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. Other Name: Arctic Front
Active Comparator: Control 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 Other Name: Tambocor

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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

Medtronic Atrial Fibrillation Solutions

Medtronic

Investigators

Principal Investigator:

Douglas L. Packer, MD

Mayo Clinic

More Information

No publications provided

Responsible Party:	Linda Nelson, RN / Sr Clinical Research Manager, Medtronic CryoCath LP
ClinicalTrials.gov Identifier:	NCT00523978 History of Changes
Other Study ID Numbers:	PS-023
Study First Received:	August 31, 2007
Last Updated:	July 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Atrial Fibrillation Solutions:

Atrial Fibrillation

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Propafenone
Flecainide
Sotalol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012