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

NCT ID: NCT03190395

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-20
• Study Completion Date: 2021-08-31

Brief 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.

Detailed 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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPVI Group

CPVI Group: Pure Circumferential pulmonary vein isolation(CPVI)

Group Type: EXPERIMENTAL

CPVI Group

Intervention Type: PROCEDURE

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: Circumferential pulmonary vein isolation combine with Left Atrium Roofline Ablation

Group Type: ACTIVE_COMPARATOR

CPVI+LARA Group

Intervention Type: PROCEDURE

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.

Interventions

CPVI Group

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

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Pure Circumferential pulmonary vein isolation; Circumferential pulmonary vein isolation combine with Left atrium roofline ablation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pingzhen Yang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Zhujiang Hospital

Locations

Zhujiang Hospital,Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liqing Wang, Doctor

Role: CONTACT

wliqing2014@163.com

+86-02062783391

Facility Contacts

Liqing Wang, Doctor

Role: primary

wliqing2014@163.com

+86-02062783391

Other Identifiers

C1033415

Identifier Type: -

Identifier Source: org_study_id