A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation (Stop-AF)
This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90 days after study therapy was initiated was considered a blanked period for all subjects.
Paroxysmal Atrial Fibrillation
Device: Arctic Front® Cryoablation Catheter
Drug: Flecainide or Sotalol or Propafenone
|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.|
- Acute Procedural Success (APS) [ Time Frame: 371.4 Minutes (Average) ] [ Designated as safety issue: No ]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.
- Freedom From Chronic Treatment Failure (CTF) [ Time Frame: 12 month follow up period ] [ Designated as safety issue: No ]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.
- Treatment Success [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Freedom From Major Atrial Fibrillation Events (MAFEs) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]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.
- Cryoablation Procedure Events (CPEs) [ Time Frame: To end of ablation procedure ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||October 2006|
|Study Completion Date:||July 2011|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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).
Device: Arctic Front® Cryoablation Catheter
Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system.
Active Comparator: Control
Control Subjects were treated with an AF Drug (flecainide, propafenone, or sotalol) that they had not previously failed.
Drug: Flecainide or Sotalol or Propafenone
Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523978
Hide Study Locations
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294-0007|
|United States, Arizona|
|Banner Good Samaritan Medical Center|
|Phoenix, Arizona, United States, 85006|
|United States, California|
|Cedar Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|UC Davis Medical Center|
|Sacramento, California, United States, 98517|
|Stanford, California, United States, 94305-5233|
|United States, Colorado|
|Colorado Cardiac Alliance -- Memorial Hospital|
|Colorado Springs, Colorado, United States, 80907|
|United States, Florida|
|Mayo Clinic- Jacksonville|
|Jacksonville, Florida, United States, 32224|
|BayHeart Group -- St-Joseph's Hospital|
|Tampa, Florida, United States, 33607|
|United States, Georgia|
|Emery Crawford Long Hospital|
|Atlanta, Georgia, United States, 30308|
|Atlanta, Georgia, United States, 30309|
|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|
|Rochester, Minnesota, United States, 55902|
|United States, New Mexico|
|New Mexico Heart Institute|
|Albuquerque, New Mexico, United States, 87102|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|United States, Ohio|
|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|
|Sentara CV Research Institute|
|Norfolk, Virginia, United States, 23507|
|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|
|London Medical Health Sciences|
|London, Ontario, Canada, N6A5A5|
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1C8|
|Ste-Foy, Quebec, Canada, G1V 4G5|
|Principal Investigator:||Douglas L. Packer, MD||Mayo Clinic|