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Bipolar Radiofrequency Ablation Plus Argon Beam Coagulator Ablation for Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
argon beam coagulator ablation
bipolar radiofrequency ablation
argon beam coagulator (American,Valleylab)
bipolar radiofrequency (AtricuteTM)
Sponsored by
Xinqiao Hospital of Chongqing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring bipolar radiofrequency ablation, argon beam coagulator

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patients got atrial fibrillation with rheumatic heart disease need surgical radiofrequency ablation treatment

Exclusion Criteria:

  • left atrial diameter>65mm,
  • sick sinus syndrome,
  • atrioventricular block,
  • ventricular tachycardia,
  • reoperation patients,
  • implantation of permanent pacemaker,
  • NYHA(New York Heart Association) class IV,
  • Malignant tumor, or other serious diseases which life expectancy < 1 year,
  • Heating temperature above 38 degrees or active infection.

Sites / Locations

  • Lin ChenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Argon beam coagulator ablation group

Bipolar radiofrequency ablation group

Arm Description

In the bipolar left atrial radiofrequency ablation, when the linear ablation was performed through along the lower edge of interatrial groove incision up to the mitral annulus, there is a gap between the ends of the ablation line and the mitral annulus And in the bipolar right atrial radiofrequency ablation, when the linear ablation was performed along the lower edge of the coronary sinus ostium up to the inferoseptal commissure and through the vertical incision on anterior wall of the right atrium up to the tricuspid annulus. There also have gaps between ends of the ablation line and the tricuspid annulus. In the experimental group the investigators plan to use conventional bipolar radiofrequency ablation and use argon beam coagulator to ablate these gaps.

Only use conventional bipolar radiofrequency ablation and do not deal with these gaps.

Outcomes

Primary Outcome Measures

electrocardiogram:rates of cardioversion of atrial fibrillation
The investigators plan to check the electrocardiogram of all the 200 individuals involved in our study 3 years after surgery to ensure the rate of cardioversion of atrial fibrillation

Secondary Outcome Measures

surgery time
cardiopulmonary bypass time
long-term recurrence rate of atrial fibrillation
complication after surgery
Number of adverse events as an assessment of complications after surgery
radiofrequency ablation time
hospital stays
participants will be followed for the duration of hospital stay,an expected average of 4 weeks

Full Information

First Posted
April 8, 2015
Last Updated
January 25, 2017
Sponsor
Xinqiao Hospital of Chongqing
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1. Study Identification

Unique Protocol Identification Number
NCT02424110
Brief Title
Bipolar Radiofrequency Ablation Plus Argon Beam Coagulator Ablation for Atrial Fibrillation
Official Title
Bipolar Radiofrequency Ablation Plus Endocardial Ablation Using Argon Beam Coagulator for Atrial Fibrillation Treatment in Patients With Rheumatic Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to make up the technique blind spots of the bipolar radiofrequency ablation in the surgical treatment of atrial fibrillation with rheumatic heart disease by using argon beam coagulator. And to improve the rates of cardioversion of atrial fibrillation after surgery, to decrease the long-term recurrence rate of atrial fibrillation and to compare the early term and long term outcomes of bipolar radiofrequency ablation and bipolar radiofrequency plus argon beam coagulator ablation.
Detailed Description
Atrial fibrillation(AF) is the most common sustained arrhythmia. It can cause reduced heart function and increase the risk of thromboembolism. About 60% of patients with rheumatic heart disease have persistent AF.AF surgery is an effective intervention for patients with all types of AF undergoing concomitant cardiac surgery. AF surgery can reduce the risks of heart of stroke and heart failure and promote longer survival. Bipolar radiofrequency ablation is one of the most effective ways. But in the investigators' early study we find that there are technique blind spots in the left atrial ablation and right atrial ablation. In the bipolar left atrial linear ablation performed along the lower edge of interatrial groove incision up to the mitral annulus, there is a gap between the ends of the ablation line to the mitral annulus. And if the investigators use bipolar radiofrequency pliers it may injure the lcx left circumflex artery and left ventricular. In the bipolar right atrial radiofrequency ablation, the linear ablation performed along the lower edge of the coronary sinus ostium up to the inferoseptal commissure and the linear performed through the vertical incision on anterior wall of the right atrium up to the tricuspid annulus, there is also a gap between the end of the end of the ablation line and the tricuspid annulus. These gaps are one of factors of the recurrence of AF. Argon beam coagulator is one of the most common hemostasis tools in heart surgery. It can also cause coagulation necrosis of the myocardium and do not do harm to the nearly myocardium the same as bipolar radiofrequency ablation. In the investigators' early study the investigators use the coagulation de plasma argon to burn the endocardium. And in the investigators' 6 mouth follow up, the rate of cardioversion is 90%. In this study the investigators plan to use argon beam coagulator to ablate these gaps. The objective of the study is to make up the technique blind spots of the bipolar radiofrequency ablation in the surgical treatment of atrial fibrillation with rheumatic heart disease by using argon beam coagulator. And to improve the rates of cardioversion of atrial fibrillation after surgery, to decrease the long-term recurrence rate of atrial fibrillation and to compare the early term and long term outcomes of bipolar radiofrequency ablation and bipolar radiofrequency plusargon beam coagulator ablation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
bipolar radiofrequency ablation, argon beam coagulator

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Argon beam coagulator ablation group
Arm Type
Experimental
Arm Description
In the bipolar left atrial radiofrequency ablation, when the linear ablation was performed through along the lower edge of interatrial groove incision up to the mitral annulus, there is a gap between the ends of the ablation line and the mitral annulus And in the bipolar right atrial radiofrequency ablation, when the linear ablation was performed along the lower edge of the coronary sinus ostium up to the inferoseptal commissure and through the vertical incision on anterior wall of the right atrium up to the tricuspid annulus. There also have gaps between ends of the ablation line and the tricuspid annulus. In the experimental group the investigators plan to use conventional bipolar radiofrequency ablation and use argon beam coagulator to ablate these gaps.
Arm Title
Bipolar radiofrequency ablation group
Arm Type
Experimental
Arm Description
Only use conventional bipolar radiofrequency ablation and do not deal with these gaps.
Intervention Type
Procedure
Intervention Name(s)
argon beam coagulator ablation
Intervention Description
The investigators plan to use argon beam coagulator ablation plus bipolar radiofrequency ablation in the argon beam coagulator ablation group.
Intervention Type
Procedure
Intervention Name(s)
bipolar radiofrequency ablation
Intervention Description
The investigators only use bipolar radiofrequency ablation in the left and right atrial radiofrequency ablation.
Intervention Type
Device
Intervention Name(s)
argon beam coagulator (American,Valleylab)
Intervention Description
Argon beam coagulator(American,Valleylab)will be used in the argon beam coagulator ablation group
Intervention Type
Device
Intervention Name(s)
bipolar radiofrequency (AtricuteTM)
Intervention Description
The investigators plan to use bipolar radiofrequency(AtricuteTM) in the bipolar radiofrequency group
Primary Outcome Measure Information:
Title
electrocardiogram:rates of cardioversion of atrial fibrillation
Description
The investigators plan to check the electrocardiogram of all the 200 individuals involved in our study 3 years after surgery to ensure the rate of cardioversion of atrial fibrillation
Time Frame
3 years after surgery
Secondary Outcome Measure Information:
Title
surgery time
Time Frame
during surgery
Title
cardiopulmonary bypass time
Time Frame
during surgery
Title
long-term recurrence rate of atrial fibrillation
Time Frame
3 years
Title
complication after surgery
Description
Number of adverse events as an assessment of complications after surgery
Time Frame
3 years
Title
radiofrequency ablation time
Time Frame
during surgery
Title
hospital stays
Description
participants will be followed for the duration of hospital stay,an expected average of 4 weeks
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients got atrial fibrillation with rheumatic heart disease need surgical radiofrequency ablation treatment Exclusion Criteria: left atrial diameter>65mm, sick sinus syndrome, atrioventricular block, ventricular tachycardia, reoperation patients, implantation of permanent pacemaker, NYHA(New York Heart Association) class IV, Malignant tumor, or other serious diseases which life expectancy < 1 year, Heating temperature above 38 degrees or active infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Chen
Phone
+86-23-68774107
Email
chenlin_xq@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mingwen Li
Phone
+86-23-68774107
Email
509044544@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Chen
Organizational Affiliation
Department of Cardiovascular Surgery, Xinqiao Hospital, Third Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Lin Chen
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Chen, PhD
Phone
8602368774107
Email
chenlin_xq@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
[1] Hong L, Lin C, Yinbing X, et al. Early Efficacy Analysis of Biatrial Ablation versus Left and Simplified Right Atrial Ablation for Atrial Fibrillation Treatment in Patients with Rheumatic Heart Disease. Heart Lung Circ. 2015 [2] Hussein AA, Wazni OM, Harb S, Joseph L, Chamsi-Pasha M, Bhargava M,et al. Radiofrequency Ablation of Atrial Fibrillation in Patients With Mechanical Mitral Valve Prostheses. J Am Coll Cardio 2011;58:596-602 [3] PasicM, Bergs P, Muller P, et al. Intraoperative radiofrequencymaze ablation for trail fibrillation: the berlin modification [J]. Ann Thorac Surg,2001,72(5):1484-1490 [4] WilliamsM R, GarridoM, OzMC, et al. Alternative energy source for surgical atrial ablation [J].J Card Surg,2004,19(3):201-206 [5] Nitta T. Surgery for trail fibrillation: a worldwide review [J]. Semin Thorac Cardiovasc Surg, 2007, 19(1):3-8
Results Reference
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Bipolar Radiofrequency Ablation Plus Argon Beam Coagulator Ablation for Atrial Fibrillation

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