Catheter Ablation Versus Antiarrythmic Drugs for Atrial Fibrillation in China

Study Overview
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Brief Summary
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The mainstay of treatment for atrial fibrillation remains pharmacological;however,catheter ablation has increasingly been used over the last decades. The relative merits of each strategy have not been extensively studied. Our study was designed to determine if catheter ablation is a feasible option as first-line therapy for treating patients with symptomatic AF.

Official Title
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Atrial Fibrillation Therapy: A Multi-Center Clinical Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: catheter ablation
* Drug: Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 Patients with symptomatic AF recorded by ECG or Holter 2 Age:18-75 years 3 Patients who are willing to enroll in the trial Exclusion Criteria: 1 Patients accompanied hyperthyroidism 2 Patients with sever liver or renal dysfunction 3 Patients with sever cardiac dysfunction 4 Patients had previous radiofrequency catheter ablation in the LA or Maze surgical procedure 5 Patients with emboli in atrium 6 Pregnant woman

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antiarrythmic Drugs<br> | Drug: Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists<br> <br> |
| Experimental: ablation<br> | Procedure: catheter ablation<br>* circumferential pulmonary vein isolation complex fractionated atrial electrograms ablation circumferential pulmonary vein isolation combined left atrial roof ablation circumferential pulmonary vein isolation combined left atrial isthmus ablation circumferential pulmonary vein isolation combined left atrial roof and isthmus ablation circumferential pulmonary vein isolation combined complex fractionated atrial electrograms ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with all-cause death |  | 3 month | 
| Number of participants with all-cause death |  | 12 month | 
| Number of participants with all-cause death |  | 24 month | 
| Number of participants with all-cause death |  | 36 month | 
| severe blooding complications |  | 3 month | 
| severe blooding complications |  | 12 month | 
| severe blooding complications |  | 24 month | 
| severe blooding complications |  | 36 month | 
| cardio-cerebrovascular complications |  | 3 month | 
| cardio-cerebrovascular complications |  | 12 month | 
| cardio-cerebrovascular complications |  | 24 month | 
| cardio-cerebrovascular complications |  | 36 month | 
| Number of participants with cardiovascular death events |  | 3 month | 
| Number of participants with cardiovascular death events |  | 12 month | 
| Number of participants with cardiovascular death events |  | 24 month | 
| Number of participants with cardiovascular death events |  | 36 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of atrial arrhythmias (AF, AFL, AT) |  | 3 month | 
| recurrence of atrial arrhythmias (AF, AFL, AT) |  | 12 month | 
| recurrence of atrial arrhythmias (AF, AFL, AT) |  | 24 month | 
| recurrence of atrial arrhythmias (AF, AFL, AT) |  | 36 month | 
| resource utilization and costs |  | 12 month | 
| resource utilization and costs |  | 24 month | 
| resource utilization and costs |  | 36 month |