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


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Verified September 2016 by Zhujiang Hospital

Sponsor:

Collaborator:

Nanfang Hospital of Southern Medical University

Information provided by (Responsible Party):

Zhujiang Hospital

ClinicalTrials.gov Identifier:

NCT03190395

First received: June 13, 2017

Last updated: June 13, 2017

Last verified: September 2016

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.

Paroxysmal Atrial Fibrillation Procedure: CPVI Group
Procedure: CPVI+LARA Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: No masking
Primary Purpose: Treatment

Official Title: Compared to the Long-term Clinical Outcome of Circumferential Pulmonary Vein Isolation(CPVI) and CPVI Combine With Left Atrial Roofline Ablation(CVPI+LARA) for Treating Patients With Paroxysmal Atrial Fibrillation Prospective Randomised Study

Primary Outcome Measures:

Secondary Outcome Measures:

  • The size of the left atrium [ Time Frame: 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 size of the left atrium measured by Transthoracic echocardiography

  • The Left Ventricular Ejection Fraction [ Time Frame: 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 ]

    The Left Ventricular Ejection Fraction measured by Transthoracic echocardiography maybe improve when heart rhytum becom sinus rhytum after ablation operation.

Estimated Enrollment: 120
Anticipated Study Start Date: June 30, 2017
Estimated Study Completion Date: August 31, 2021
Estimated Primary Completion Date: September 1, 2018 (Final data collection date for primary outcome measure)
Experimental: CPVI Group

CPVI Group: Pure Circumferential pulmonary vein isolation(CPVI)

Procedure: CPVI Group

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

Other Name: Pure Circumferential pulmonary vein isolation

Active Comparator: CPVI+LARA Group

CPVI+LARA Group: Circumferential pulmonary vein isolation combine with Left Atrium Roofline Ablation

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.

Other Name: Circumferential pulmonary vein isolation combine with Left atrium roofline ablation

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03190395

Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, China, 510282
Contact: Liqing Wang, Doctor    +86-02062783391    wliqing2014@163.com   
Principal Investigator: Pingzhen Yang, Doctor         

Zhujiang Hospital

Nanfang Hospital of Southern Medical University

Principal Investigator: Pingzhen Yang, Doctor Zhujiang Hospital

Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT03190395     History of Changes
Other Study ID Numbers: C1033415
Study First Received: June 13, 2017
Last Updated: June 13, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhujiang Hospital:

Paroxysmal Atrial Fibrillation
Circumferential Pulmonary Vein Isolation(CPVI)
Leftatrium Roofline Ablation(LARA)
Longterm success rate

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 16, 2017