Comparison of RF and crYoballoon ablatiOn Therapy of AF（CRYO-AF）

Study Overview
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Brief Summary
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It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.

Detailed Description
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The hypothesis of this study is that pulmonary vein isolation with cryoballoon ablation is not inferior to radiofrequency ablation with 3D mapping with respect to clinical safety and efficacy.

Official Title
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Cryoballoon Versus Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: cryoballoon ablation
* Procedure: radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ECG recording of atrial fibrillation first time of ablation refractory to at least one anti-arrhythmia drug sign informed consent for participation in the study Exclusion Criteria: had ablation before serious heart failure left atrial diameter>55mm Myocardial infarction, heart surgery or coronary intervention in 3 months before the ablation Stroke in 6 months before the ablation Endocardial thrombosis

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cryoballoon ablation<br>patients who accept cryoballoon ablation | Procedure: cryoballoon ablation<br>* cryoballoon ablation：pulmonary vein isolation by cryoballoon<br>|
| Active Comparator: radiofrequency ablation<br>patients who accept radiofrequency ablation | Procedure: radiofrequency ablation<br>* radiofrequency ablation: pulmonary vein isolation by radiofrequency energy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy endpoint (time to first documented clinical recurrence after blanking period) | the time to first documented clinical recurrence after blanking period (month) | one year | 
| Safety endpoint (Any procedure-related complications) | Any procedure-related complications | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time (min) | skin to skin | one year | 
| Left atrial time (min) |  | one year | 
| X-ray time (min) |  | one year | 
| time to first time cardiovascular hospitalization (month) |  | one year | 
| QoL changes at 12 months (Units on a Scale) |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, cryoablation, irrigated radiofrequency ablation, pulmonary vein isolation