- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00523978
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation (Stop-AF)
A Randomized, Controlled Clinical Trial of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
STOP AF (PS-023) is a randomized, controlled study of subjects 18 to 75 years old who had been referred for ablative intervention after failing one or two (but not all three) anti-arrhythmic drugs used in the treatment of AF (flecainide, propafenone and sotalol). Study subjects were randomized into two arms: the cryoablation (treatment) arm and the membrane-active antiarrhythmic drug (control) arm. A 90- day blanked follow-up period, including reablation and medication adjustments was applied in both arms to optimize therapies. All subjects underwent follow-up assessments at 1, 3, 6, 9 and 12 months, weekly transtelephonic monitoring, 24-hour Holter monitoring and CT/MRI of the pulmonary veins(at 6 and 12 months) during the trial period. Control subjects who were confirmed to be chronic treatment failures were permitted to crossover to cryoablation in this trial.
Acute procedural success was defined for subjects that underwent cryoablation and demonstrated electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure using the Arctic Front® Cardiac CryoAblation Catheter System.
The primary effectiveness endpoint was defined as having acute procedural success and freedom from chronic treatment failure (CTF) for experimental subjects, and freedom from CTF for control subjects. Freedom from (CTF) was defined for both groups as the occurrence of detectable AF during a non-blanked follow-up period, or an AF Intervention, or the use of a non-study AF drug at any time.
The co-primary safety outcome measures were Cryoablation Procedure Events (CPEs) in cryoablated subjects and Major Atrial Fibrillation Events (MAFEs) in both groups. CPEs were device- or procedure-related serious adverse events.
Other safety assessments were made during the course of the STOP AF trial specific to pulmonary vein stenosis (PVS) and phrenic nerve injury.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ontario
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London, Ontario, Canada, N6A5A5
- London Medical Health Sciences
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Quebec
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Montreal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
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Ste-Foy, Quebec, Canada, G1V 4G5
- Laval Hospital
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Alabama
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Birmingham, Alabama, United States, 35294-0007
- University of Alabama
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Arizona
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Phoenix, Arizona, United States, 85006
- Banner Good Samaritan Medical Center
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California
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Los Angeles, California, United States, 90048
- Cedar Sinai Medical Center
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Sacramento, California, United States, 98517
- UC Davis Medical Center
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Stanford, California, United States, 94305-5233
- Stanford hospital
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Colorado
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Colorado Springs, Colorado, United States, 80907
- Colorado Cardiac Alliance -- Memorial Hospital
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic- Jacksonville
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Tampa, Florida, United States, 33607
- BayHeart Group -- St-Joseph's Hospital
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Georgia
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Atlanta, Georgia, United States, 30309
- Piedmont Hospital
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Atlanta, Georgia, United States, 30308
- Emery Crawford Long Hospital
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Iowa
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Des Moines, Iowa, United States, 50314
- Iowa Heart Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Minnesota
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Rochester, Minnesota, United States, 55902
- Mayo Clinic
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- New Mexico Heart Institute
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104-4283
- University of Pennsylvania Health
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Texas
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Dallas, Texas, United States, 75226
- Baylor Heart and Vascular Hospital
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Virginia
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Falls Church, Virginia, United States, 22042
- Inova Research Center
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Norfolk, Virginia, United States, 23507
- Sentara CV Research Institute
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Richmond, Virginia, United States, 23219
- Medical College of Virginia
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Wisconsin
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Green Bay, Wisconsin, United States, 54301-3596
- Cardiology Associates of Green Bay
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Milwaukee, Wisconsin, United States, 53215
- Arrhythmia Center of Southern WI
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Experimental
Experimental subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci.
If necessary, experimental subjects were allowed a previously failed Study Atrial Fibrillation Drug (AF Drug).
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Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system.
Other Names:
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Active Comparator: Control
Control Subjects were treated with an AF Drug (flecainide, propafenone, or sotalol) that they had not previously failed.
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Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Procedural Success (APS)
Time Frame: 371.4 Minutes (Average)
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Acute Procedural Success was defined as a demonstration of electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure.
APS was decided at the end of the procedure the mean time was calculated for the time frame.
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371.4 Minutes (Average)
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Freedom From Chronic Treatment Failure (CTF)
Time Frame: 12 month follow up period
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Subjects that did not have or were free of CTF.
CTF was defined as the occurence of an Atrial Fibrillation (AF) intervention, use of non-study AF drug therapy, or the occurence of detectable AF which is is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.
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12 month follow up period
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Treatment Success
Time Frame: 12 months
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Treatment Success was defined as Acute Procedure Success (APS) and freedom from Chronic Treatment Failure (CTF) for Experimental Subjects, and freedom from CTF for Control Subjects.
Under this pre-specified definition of Treatment Success, Experimental Subjects must have had APS and remained free of CTF during the 12-month follow-up duration, while Control Subjects must have remained free of CTF during the 12-month follow-up duration.
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12 months
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Freedom From Major Atrial Fibrillation Events (MAFEs)
Time Frame: 12 Months
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Subjects that did not have or were free of MAFEs.
MAFEs were serious adverse events categorized as cardiovascular death, myocardial infarction, stroke, or hospitalization for AF recurrence/ablation, flutter ablation, embolic events, heart failure, hemorrhage or anti-arrhythmic drug treatment.
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12 Months
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Cryoablation Procedure Events (CPEs)
Time Frame: To end of ablation procedure
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Subjects that had CPEs.
CPEs were device- or procedure-related serious adverse events (SAE) categorized as access site complications, cardiac damage, pulmonary vein (PV) stenosis, embolic complications, arrhythmias, unresolved phrenic nerve palsy and death.
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To end of ablation procedure
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Douglas L. Packer, MD, Mayo Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Membrane Transport Modulators
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Sympatholytics
- Flecainide
- Sotalol
- Propafenone
Other Study ID Numbers
- PS-023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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