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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CPVI Group
CPVI+LARA Group
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Paroxysmal Atrial Fibrillation, Circumferential Pulmonary Vein Isolation(CPVI), Leftatrium Roofline Ablation(LARA), Longterm success rate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhujiang Hospital,Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CPVI Group

CPVI+LARA Group

Arm Description

CPVI Group: Pure Circumferential pulmonary vein isolation(CPVI)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The size of the left atrium
The size of the left atrium measured by Transthoracic echocardiography
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.

Full Information

First Posted
June 13, 2017
Last Updated
January 14, 2019
Sponsor
Zhujiang Hospital
Collaborators
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03190395
Brief Title
Compared With 2 Different Ablation Strategies Clinical Outcome for Treating Patients With Paroxysmal Atrial Fibrillation
Official Title
Compared With 2 Different Ablation Strategies Clinical Outcome for Treating Patients With Paroxysmal Atrial Fibrillation,Prospective Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2019 (Anticipated)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital
Collaborators
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Paroxysmal Atrial Fibrillation, Circumferential Pulmonary Vein Isolation(CPVI), Leftatrium Roofline Ablation(LARA), Longterm success rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPVI Group
Arm Type
Experimental
Arm Description
CPVI Group: Pure Circumferential pulmonary vein isolation(CPVI)
Arm Title
CPVI+LARA Group
Arm Type
Active Comparator
Arm Description
CPVI+LARA Group: Circumferential pulmonary vein isolation combine with Left Atrium Roofline Ablation
Intervention Type
Procedure
Intervention Name(s)
CPVI Group
Other Intervention Name(s)
Pure Circumferential pulmonary vein isolation
Intervention Description
CPVI Group:The ablation strategy of Circumferential pulmonary vein isolation (CPVI)will be operated on 60 patients with paroxysmal atrial fibrillation.
Intervention Type
Procedure
Intervention Name(s)
CPVI+LARA Group
Other Intervention Name(s)
Circumferential pulmonary vein isolation combine with Left atrium roofline ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maintenance time of sinus rhythm
Description
To evaluate the effectiveness of the ablation operation, we will observe how long will these patients keep sinus rhythm after operation.
Time Frame
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 Measure Information:
Title
The size of the left atrium
Description
The size of the left atrium measured by Transthoracic echocardiography
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
Title
The Left Ventricular Ejection Fraction
Description
The Left Ventricular Ejection Fraction measured by Transthoracic echocardiography maybe improve when heart rhytum becom sinus rhytum after ablation operation.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liqing Wang, Doctor
Phone
+86-02062783391
Email
wliqing2014@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pingzhen Yang, Doctor
Organizational Affiliation
Zhujiang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhujiang Hospital,Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqing Wang, Doctor
Phone
+86-02062783391
Email
wliqing2014@163.com
First Name & Middle Initial & Last Name & Degree
Pingzhen Yang, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No

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

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