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A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation

Information source: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Paroxysmal Atrial Fibrillation

Intervention: Arctic Front® Cryoablation Catheter (Device); Flecainide or Sotalol or Propafenone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Medtronic Atrial Fibrillation Solutions

Official(s) and/or principal investigator(s):
Douglas L. Packer, MD, Principal Investigator, Affiliation: Mayo Clinic

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.

Clinical Details

Official title: A Randomized, Controlled Clinical Trial of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Acute Procedural Success (APS)

Freedom From Chronic Treatment Failure (CTF)

Treatment Success

Freedom From Major Atrial Fibrillation Events (MAFEs)

Cryoablation Procedure Events (CPEs)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

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, Bronx, New York 10467, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

London Medical Health Sciences, London, Ontario N6A5A5, Canada

University of Pennsylvania Health, Philadelphia, Pennsylvania 19104-4283, United States

Montreal Heart Institute, Montreal, Quebec H1T 1C8, Canada

Laval Hospital, Ste-Foy, Quebec G1V 4G5, Canada

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

Additional Information

Starting date: October 2006
Last updated: July 25, 2012

Page last updated: August 23, 2015

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