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

NCT03190395 | Unknown DMC

• 1 other identifier: C1033415
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The size of the left atrium

  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

  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

Study Arms (2)

CPVI Group

EXPERIMENTAL

CPVI Group: Pure Circumferential pulmonary vein isolation(CPVI)

Procedure: CPVI Group

CPVI+LARA Group

ACTIVE COMPARATOR

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

Procedure: CPVI+LARA Group

Interventions

CPVI Group PROCEDURE

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

Also known as: Pure Circumferential pulmonary vein isolation

CPVI Group

CPVI+LARA Group 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.

Also known as: Circumferential pulmonary vein isolation combine with Left atrium roofline ablation

CPVI+LARA Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- (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

You may not qualify if:

• (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

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Nanfang Hospital, Southern Medical University: collaborator

Study Sites (1)

Zhujiang Hospital,Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pingzhen Yang, Doctor

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liqing Wang, Doctor

CONTACT

+86-02062783391; wliqing2014@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Contorol Group:Pure Circumferential pulmonary vein isolation(CPVI) Experimental Group:Circumferential pulmonary vein isolation combine with Left atrium roofline ablation(CPVI+LARA)

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 16, 2017
• Study Start: January 20, 2019
• Primary Completion: September 1, 2019
• Study Completion: August 31, 2021
• Last Updated: January 15, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)