Bipolar Radiofrequency Ablation Plus Argon Beam Coagulator Ablation for Atrial Fibrillation
NCT ID: NCT02424110
Last Updated: 2017-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2015-07-31
2018-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Argon beam coagulator ablation group
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.
argon beam coagulator ablation
The investigators plan to use argon beam coagulator ablation plus bipolar radiofrequency ablation in the argon beam coagulator ablation group.
argon beam coagulator （American，Valleylab）
Argon beam coagulator（American，Valleylab）will be used in the argon beam coagulator ablation group
Bipolar radiofrequency ablation group
Only use conventional bipolar radiofrequency ablation and do not deal with these gaps.
bipolar radiofrequency ablation
The investigators only use bipolar radiofrequency ablation in the left and right atrial radiofrequency ablation.
bipolar radiofrequency (AtricuteTM)
The investigators plan to use bipolar radiofrequency(AtricuteTM) in the bipolar radiofrequency group
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Xinqiao Hospital of Chongqing
OTHER
Responsible Party
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Mingwen Li
Resident surgeon in the Department of Cardiovascular Surgery of Xinqiao Hospital
Principal Investigators
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Lin Chen
Role: STUDY_DIRECTOR
Department of Cardiovascular Surgery, Xinqiao Hospital, Third Military Medical University
Locations
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Lin Chen
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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[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
Other Identifiers
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xqxwk_07
Identifier Type: -
Identifier Source: org_study_id
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