Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy

Study Overview
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Brief Summary
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Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Cryoballoon ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: paroxysmal atrial fibrillation, symptomatic Exclusion Criteria: atrial fibrillation other than PAF, asymptomatic, previous AF ablation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoballoon ablation<br>Cryoballoon ablation | Device: Cryoballoon ablation<br> <br> |
| Active Comparator: Cryoballoon after medical therapy<br>Cryoballoon ablation | Device: Cryoballoon ablation<br> <br> |
| Experimental: Cryoballoon as first-line therapy<br>Cryoballoon ablation | Device: Cryoballoon ablation<br> <br> |
| Active Comparator: Cryoballoon after failed drug therapy<br>Cryoballoon ablation | Device: Cryoballoon ablation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite) | At prespecified interval of 12th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring | 12 months from the procedure | 
| Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite) | At prespecified interval of 3rd month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring | 3 months from the procedure | 
| Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite) | At prespecified interval of 6th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring | 6 months from the procedure | 
| Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite) | At prespecified interval of 9th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring | 9 months from the procedure |