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

NCT ID: NCT00523978

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2011-07-31

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.

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Arctic Front® Cryoablation Catheter

Intervention Type: DEVICE

Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system.

Control

Control Subjects were treated with an AF Drug (flecainide, propafenone, or sotalol) that they had not previously failed.

Group Type: ACTIVE_COMPARATOR

Flecainide or Sotalol or Propafenone

Intervention Type: DRUG

Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day

Interventions

Arctic Front® Cryoablation Catheter

Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system.

Intervention Type: DEVICE

Flecainide or Sotalol or Propafenone

Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day

Intervention Type: DRUG

Other Intervention Names

Arctic Front® Cardiac CryoAblation Catheter System; Artic Front®; Tambocor; Sotalol; Propafenone

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas L. Packer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

University of Alabama

Birmingham, Alabama, United States

Banner Good Samaritan Medical Center

Phoenix, Arizona, United States

Cedar Sinai Medical Center

Los Angeles, California, United States

UC Davis Medical Center

Sacramento, California, United States

Stanford Hospital

Stanford, California, United States

Colorado Cardiac Alliance -- Memorial Hospital

Colorado Springs, Colorado, United States

Mayo Clinic- Jacksonville

Jacksonville, Florida, United States

BayHeart Group -- St-Joseph's Hospital

Tampa, Florida, United States

Emery Crawford Long Hospital

Atlanta, Georgia, United States

Piedmont Hospital

Atlanta, Georgia, United States

Iowa Heart Center

Des Moines, Iowa, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

New Mexico Heart Institute

Albuquerque, New Mexico, United States

Montefiore Medical Center

The Bronx, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Pennsylvania Health

Philadelphia, Pennsylvania, United States

Baylor Heart and Vascular Hospital

Dallas, Texas, United States

Inova Research Center

Falls Church, Virginia, United States

Sentara CV Research Institute

Norfolk, Virginia, United States

Medical College of Virginia

Richmond, Virginia, United States

Cardiology Associates of Green Bay

Green Bay, Wisconsin, United States

Arrhythmia Center of Southern WI

Milwaukee, Wisconsin, United States

London Medical Health Sciences

London, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Laval Hospital

Ste-Foy, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 23500312 (View on PubMed)

Other Identifiers

PS-023

Identifier Type: -

Identifier Source: org_study_id