Bipolar Radiofrequency Ablation Plus Argon Beam Coagulator Ablation for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Bipolar Radiofrequency Ablation Plus Endocardial Ablation Using Argon Beam Coagulator for Atrial Fibrillation Treatment in Patients With Rheumatic Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02424110
• Other study ID #: xqxwk_07
• Status: Recruiting
• Phase: N/A
• First received: April 8, 2015
• Last updated: January 25, 2017
• Start date: July 2015
• Est. completion date: May 2018

Study information

• Verified date: July 2016
• Source: Xinqiao Hospital of Chongqing
• Contact: Lin Chen
• Phone: +86-23-68774107
• Email: chenlin_xq[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• argon beam coagulator ablation
The investigators plan to use argon beam coagulator ablation plus bipolar radiofrequency ablation in the argon beam coagulator ablation group.
• bipolar radiofrequency ablation
The investigators only use bipolar radiofrequency ablation in the left and right atrial radiofrequency ablation.

Device:
• argon beam coagulator (American,Valleylab)
Argon beam coagulator(American,Valleylab)will be used in the argon beam coagulator ablation group
• bipolar radiofrequency (AtricuteTM)
The investigators plan to use bipolar radiofrequency(AtricuteTM) in the bipolar radiofrequency group

Locations

Country	Name	City	State
China	Lin Chen	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

References & Publications (1)

[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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years after surgery
Secondary	surgery time		during surgery
Secondary	cardiopulmonary bypass time		during surgery
Secondary	long-term recurrence rate of atrial fibrillation		3 years
Secondary	complication after surgery	Number of adverse events as an assessment of complications after surgery	3 years
Secondary	radiofrequency ablation time		during surgery
Secondary	hospital stays	participants will be followed for the duration of hospital stay,an expected average of 4 weeks	4 weeks