Safety and Efficacy of CryoCor™ Cryoablation for PAF

Study Overview
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Brief Summary
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A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF

Detailed Description
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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.

Official Title
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A Clinical Study to Evaluate the Safety and Efficacy of the CryoCor(TM)Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Cardiac CryoCor Cryoablation System
* Drug: Medical management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment with CryoCor Cryoablation System<br>Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF. | Device: Cardiac CryoCor Cryoablation System<br>* Treatment with CryoCor Cardiac Cryoablation system<br>* Other names: Ablation with the CryoCor ablation catheter;|
| Active Comparator: Treatment with standard medical therapy<br>Intervention includes treatment with ant-arrhythmic medications alone. | Drug: Medical management<br>* Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications<br>* Other names: AAD treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of intervention |  | 12 months | 
| Recurrence of PAF |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QOL as measured by SF-36 Health Survey | Changes compared to baseline will be measured over a period of 12 months | 12 months | 
| Change in QOL as measured by Symptom Checklist | Changes compared to baseline will be measured over a period of 12 months | 12 months | 
| Change in QOL as measured by Arrhythmia Severity scale | Changes compared to baseline will be measured over a period of 12 months | 12 months | 
| Change in luminal PV measurements |  | 6 months | 
| Time to treatment failure, post resolution period | Time to treatment failure, defined as event monitor documented recurrent atrial fibrillation, post resolution period. | Post resolution period (12 months follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryoablation, atrial fibrillation