Efficacy and Safety Study of Catheter Ablation for Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of different procedures, identify the optimal procedure, ablation sites, ablation endpoints and post-operative anticoagulation strategy, establish the optimal treatment strategy for atrial fibrillation.

Official Title
-----------------
Catheter Ablation for Atrial Fibrillation: A Multicenter Clinical Trial

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: catheter ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrial fibrillation recorded by ECG or Holter; Age: 18   75 years; Patients who are willing to enroll in the trial Exclusion Criteria: Patients accompanied hyperthyroidism; Patients with sever liver or renal dysfunction; Patients with sever cardiac dysfunction; Patients had previous radiofrequency catheter ablation in the LA or Maze surgical procedure; Patients with emboli in atrium; Pregnant woman

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of atrial arrhythmias (AF, AFL, AT) |  | 1 month | 
| recurrence of atrial arrhythmias (AF, AFL, AT) |  | 3 month | 
| recurrence of atrial arrhythmias (AF, AFL, AT) |  | 6 month | 
| recurrence of atrial arrhythmias (AF, AFL, AT) |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with all-cause death |  | 1 month | 
| Number of participants with all-cause death |  | 3 month | 
| Number of participants with all-cause death |  | 6 month | 
| Number of participants with all-cause death |  | 12 month | 
| severe blooding complications |  | 1 month | 
| severe blooding complications |  | 3 month | 
| severe blooding complications |  | 6 month | 
| severe blooding complications |  | 12 month | 
| cardio-cerebrovascular complications |  | 1 month | 
| cardio-cerebrovascular complications |  | 3 month | 
| cardio-cerebrovascular complications |  | 6 month | 
| cardio-cerebrovascular complications |  | 12 month | 
| Number of participants with cardiovascular death events |  | 1 month | 
| Number of participants with cardiovascular death events |  | 3 month | 
| Number of participants with cardiovascular death events |  | 6 month | 
| Number of participants with cardiovascular death events |  | 12 month |