A Clinical Study to Evaluate the Safety and Efficacy of the CryoCor(TM)Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Cardiac CryoCor Cryoablation System
- Conditions
- Atrial Fibrillation
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 174
- Locations
- 24
- Primary Endpoint
- Safety profile of intervention
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF
Detailed Description
The purpose of this prospective, randomized multi-center clinical study is to establish the benefits of the CryoCor(TM) Cardiac Cryoablation System for treating symptomatic paroxysmal atrial fibrillation (PAF) in comparison to treatment with anti-arrhythmic medications alone. This study also evaluates the safety profile of the CryoCor(TM) Cardiac Cryoablation System when used in this same setting.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 3 episodes of PAF within 6 months
- •Refractory to at least one drug
- •Therapeutic anticoagulation
- •Signed informed consent
Exclusion Criteria
- •Persistent AF
- •Structural heart disease
- •Prior ablation
- •Contraindication present
Arms & Interventions
Treatment with CryoCor Cryoablation System
Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.
Intervention: Cardiac CryoCor Cryoablation System
Treatment with standard medical therapy
Intervention includes treatment with ant-arrhythmic medications alone.
Intervention: Medical management
Outcomes
Primary Outcomes
Safety profile of intervention
Time Frame: 12 months
Recurrence of PAF
Time Frame: 12 months
Secondary Outcomes
- Change in QOL as measured by Symptom Checklist(12 months)
- Change in QOL as measured by SF-36 Health Survey(12 months)
- Change in QOL as measured by Arrhythmia Severity scale(12 months)
- Change in luminal PV measurements(6 months)
- Time to treatment failure, post resolution period(Post resolution period (12 months follow-up))