Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
NCT ID: NCT01013688
Last Updated: 2009-11-18
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
PHASE3
150 participants
INTERVENTIONAL
2008-03-31
2010-05-31
Brief Summary
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Detailed Description
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150 patients with chronic AF having concomitant cardiac surgery will be enrolled. Patients will underwent bi-atrial radiofrequency,left atrial radiofrequency or no radiofrequency procedure randomly. All the patients will receipt amiodarone 200 mg/day for 12 months postoperatively.
All patients were scheduled followed before discharge and at 3rd, 6th and 12th postoperative months.The following diagnostic procedures were performed
1. Standard 12-lead electrocardiography
2. Holter-ECG
3. Transthoracic echocardiography
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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left atrial RF ablation groups
Excised the left atrial appendage Encircling the left pulmonary veins and an extension to the posterior mitral valve annulus From the left atrial appendage to the left superior pulmonary vein A connecting line between both islands of pulmonary veins From the middle of the mitral valve ablation line down towards the base of the atria ligament of Marshall
Cardioblate® Surgical Ablation System
Using Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery
Bi-atrial radiofrequency ablation group
In the basis of left atrial group,excised the right atrial appendage; from the amputated right atrial appendage towards the inferior vena cava; from the midterm of interatrial septum to the AV groove; ablation between the superior and inferior caval cannulation sites; radiofrequency ablation for Waterston's groove
Cardioblate® Surgical Ablation System
Using Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery
Amiodarone group
No radiofrequency ablation procedure during the valve surgery; Amiodarone 200 mg/day for 12 months after surgery
No interventions assigned to this group
Interventions
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Cardioblate® Surgical Ablation System
Using Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least six months and no longer than 5 years of chronic atrial fibrillation
3. Age \>=18 years and \<=70 Patients who can give informed consent themselves in writing
4. No contraindication for amiodarone
5. Negative pregnancy test (in women with childbearing potential)
Exclusion Criteria
2. Left ventricular eject fraction(LVEF)\<=30%
3. Atrial thrombus
4. Contraindication for anticoagulation therapy
5. Less than 6 months since last episode of cerebral infarction
6. Emergency operation
7. Patients with a malignant tumor
8. Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
9. Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
18 Years
70 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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China National Center for Cardiovascular Diseases
Principal Investigators
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Shengshou Hu
Role: STUDY_DIRECTOR
National center for cardiovascular disease ,china
Locations
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Fuwai cardiovascular disease hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Wangxin, MD
Role: primary
References
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Wang X, Wang X, Song Y, Hu S, Wang W. Efficiency of radiofrequency ablation for surgical treatment of chronic atrial fibrillation in rheumatic valvular disease. Int J Cardiol. 2014 Jul 1;174(3):497-502. doi: 10.1016/j.ijcard.2014.03.153. Epub 2014 Mar 29.
Other Identifiers
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Wangxin
Identifier Type: -
Identifier Source: org_study_id