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.
1 other identifier
interventional
245
2 countries
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2006
Longer than P75 for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 31, 2007
CompletedFirst Posted
Study publicly available on registry
September 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
August 28, 2012
CompletedOctober 16, 2018
September 1, 2018
3.8 years
August 31, 2007
April 10, 2012
September 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Acute Procedural Success (APS)
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.
371.4 Minutes (Average)
Freedom From Chronic Treatment Failure (CTF)
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.
12 month follow up period
Treatment Success
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.
12 months
Freedom From Major Atrial Fibrillation Events (MAFEs)
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.
12 Months
Cryoablation Procedure Events (CPEs)
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.
To end of ablation procedure
Study Arms (2)
Experimental
EXPERIMENTALExperimental 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).
Control
ACTIVE COMPARATORControl Subjects were treated with an AF Drug (flecainide, propafenone, or sotalol) that they had not previously failed.
Interventions
Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system.
Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Cardiac Rhythm and Heart Failurelead
- Medtroniccollaborator
Study Sites (26)
University of Alabama
Birmingham, Alabama, 35294-0007, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Cedar Sinai Medical Center
Los Angeles, California, 90048, United States
UC Davis Medical Center
Sacramento, California, 98517, United States
Stanford Hospital
Stanford, California, 94305-5233, United States
Colorado Cardiac Alliance -- Memorial Hospital
Colorado Springs, Colorado, 80907, United States
Mayo Clinic- Jacksonville
Jacksonville, Florida, 32224, United States
BayHeart Group -- St-Joseph's Hospital
Tampa, Florida, 33607, United States
Emery Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Iowa Heart Center
Des Moines, Iowa, 50314, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Pennsylvania Health
Philadelphia, Pennsylvania, 19104-4283, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226, United States
Inova Research Center
Falls Church, Virginia, 22042, United States
Sentara CV Research Institute
Norfolk, Virginia, 23507, United States
Medical College of Virginia
Richmond, Virginia, 23219, United States
Cardiology Associates of Green Bay
Green Bay, Wisconsin, 54301-3596, United States
Arrhythmia Center of Southern WI
Milwaukee, Wisconsin, 53215, United States
London Medical Health Sciences
London, Ontario, N6A5A5, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Laval Hospital
Ste-Foy, Quebec, G1V 4G5, Canada
Related Publications (1)
Packer DL, Kowal RC, Wheelan KR, Irwin JM, Champagne J, Guerra PG, Dubuc M, Reddy V, Nelson L, Holcomb RG, Lehmann JW, Ruskin JN; STOP AF Cryoablation Investigators. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol. 2013 Apr 23;61(16):1713-23. doi: 10.1016/j.jacc.2012.11.064. Epub 2013 Mar 21.
PMID: 23500312DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Linda Nelson, RN, BSN, MBA - AF Solutions Clinical Operations Director
- Organization
- Medtronic AF Solutions
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas L. Packer, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2007
First Posted
September 3, 2007
Study Start
October 1, 2006
Primary Completion
August 1, 2010
Study Completion
July 1, 2011
Last Updated
October 16, 2018
Results First Posted
August 28, 2012
Record last verified: 2018-09