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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medtronic Atrial Fibrillation Solutions; Medtronic Cardiac Rhythm and Heart Failure
• Collaborator: Medtronic
• Treatments: Flecainide; Propafenone; Sotalol

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