Compared With 2 Different Ablation Strategies Clinical Outcome for Treating Patients With Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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Atrial fibrillation (AF) is the most serious atrial electrical activity disorders, is also one of the common tachyarrhythmias.Circumferential pulmonary Vein Isolation (CPVI) is considered to be the cornerstone of paroxysmal atrial fibrillation ablation, but recently reported in the literature that pure CPVI treatment for paroxysmal atrial fibrillation the 5-year success rate as low as 46.6%, and the incidence of atrial reentry tachycardia is also high in the follow-up period. Therefore it is necessary for us to explore whether the success rate of CPVI combined with Leftatrium Roofline Ablation (CPVI + LARA) for paroxysmal atrial fibrillation is higher than the pure CPVI.

Detailed Description
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Atrial fibrillation (AF) refers to the orderly loss of atrial electrical activity, replaced by rapid and disorderly atrial fibrillation wave, is the most acute atrial electrical activity disorders, is also one of the common tachyarrhythmias. So far, the mechanism of atrial fibrillation has not yet been completely clarified. At present, there are various mechanisms to participate in the occurrence and maintenance of atrial fibrillation, which mainly involves two aspects. One is the triggering factor of atrial fibrillation, and the other is the occurrence and maintenance of atrial fibrillation (substrate). Trigger factors are varied, including sympathetic and parasympathetic stimulation, bradycardia, atrial premature beats or tachycardia, atrioventricular bypass and acute atrial pull, etc, which pulmonary vein electrical activity triggered the most common, but also is an most important theoretical Basis for the Radiofrequency Catheter Ablation of Atrial Fibrillation . Substrate is a necessary condition for the onset and maintenance of atrial fibrillation. Electrical remodeling and structural remodeling are by shortening the atrial effective refractory period. Atrial dilatation and atrial fibrosis play a major role in the formation of atrial fibrillation reentry.Circumferential pulmonary Vein Isolation (CPVI) is considered to be the cornerstone of paroxysmal atrial fibrillation ablation, but recently reported in the literature that pure CPVI treatment for paroxysmal atrial fibrillation the 5-year success rate as low as 46.6%, and the incidence of atrial reentry tachycardia is also high in the follow-up period. Therefore it is necessary for us to explore whether the success rate of CPVI combined with Leftatrium Roofline Ablation (CPVI + LARA) for paroxysmal atrial fibrillation is higher than the pure CPVI.

Official Title
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Compared With 2 Different Ablation Strategies Clinical Outcome for Treating Patients With Paroxysmal Atrial Fibrillation，Prospective Randomised Study

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: CPVI Group
* Procedure: CPVI+LARA Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - (1)Patients between 18-80 year-old with paroxysmal atrial fibrillation have radio frequency ablation operation indication and are willing to require AF ablation therapy. (2)Voluntary consent of informed consent (3)No AF Ablation history before admission Exclusion Criteria: (1) Permanent or persistent AF (2) The diameter of left atrium >50mm (3) Previous AF/AFL/AT Radio Frequency Ablation (4) Congenital heart disease and/or Cardiac Surgical procedures (5) AF with rheumatic valvular disease (6) LV ejection fraction <45% (7) Intracardiac thrombi

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: Contorol Group:Pure Circumferential pulmonary vein isolation(CPVI) Experimental Group:Circumferential pulmonary vein isolation combine with Left atrium roofline ablation(CPVI+LARA)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPVI Group<br>CPVI Group: Pure Circumferential pulmonary vein isolation(CPVI) | Procedure: CPVI Group<br>* CPVI Group:The ablation strategy of Circumferential pulmonary vein isolation (CPVI)will be operated on 60 patients with paroxysmal atrial fibrillation.<br>* Other names: Pure Circumferential pulmonary vein isolation;|
| Active Comparator: CPVI+LARA Group<br>CPVI+LARA Group: Circumferential pulmonary vein isolation combine with Left Atrium Roofline Ablation | Procedure: CPVI+LARA Group<br>* CPVI+LARA Group: The ablation strategy of Circumferential pulmonary vein isolation combine with Left atrium roofline ablation(CPVI+LARA) will be operated on 60 patients with paroxysmal atrial fibrillation.<br>* Other names: Circumferential pulmonary vein isolation combine with Left atrium roofline ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance time of sinus rhythm | To evaluate the effectiveness of the ablation operation, we will observe how long will these patients keep sinus rhythm after operation. | The two groups will be assessed from 3 months later operation until the recurrence of atrial fibrillation or up to 36 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The size of the left atrium | The size of the left atrium measured by Transthoracic echocardiography | Patients's size of the left atrium will be assessed from 3 months later operation until the recurrence of atrial fibrillation or up to 36 months after operation | 
| The Left Ventricular Ejection Fraction | The Left Ventricular Ejection Fraction measured by Transthoracic echocardiography maybe improve when heart rhytum becom sinus rhytum after ablation operation. | Patients's LV ejection fraction will be assessed from 3 months later operation until the recurrence of atrial fibrillation or up to 36 months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paroxysmal Atrial Fibrillation, Circumferential Pulmonary Vein Isolation(CPVI), Leftatrium Roofline Ablation(LARA), Longterm success rate