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

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03190395
• Other study ID #: C1033415
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2018
• Source: Zhujiang Hospital
• Contact: Liqing Wang, Doctor
• Phone: +86-02062783391
• Email: wliqing2014[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2021
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• CPVI Group
CPVI Group:The ablation strategy of Circumferential pulmonary vein isolation (CPVI)will be operated on 60 patients with paroxysmal atrial fibrillation.
• CPVI+LARA Group
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.

Locations

Country	Name	City	State
China	Zhujiang Hospital,Southern Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhujiang Hospital	Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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