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The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control, improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure? 150 rheumatic valve patients with chronic atrial fibrillation (AF) having concomitant valve surgery were randomized to three groups: left atrial ablation group, bi-atrial ablation group, and Amiodarone group. All patients were scheduled followed up before discharge and at 3rd, 6th and 12th postoperative months. Standard 12-lead electrocardiography (ECG), 24-hour Holter and transthoracic echocardiography were used to determine the rhythm and cardiac hemodynamic status.
The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control,improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure?
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| left atrial RF ablation groups | Experimental | 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 |
|
| Bi-atrial radiofrequency ablation group | Experimental | 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 |
|
| Amiodarone group | No Intervention | No radiofrequency ablation procedure during the valve surgery; Amiodarone 200 mg/day for 12 months after surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardioblate® Surgical Ablation System | Procedure | Using Cardioblate® Surgical Ablation System to perform left atrial or bi-atrial radiofrequency ablation procedure during valve surgery |
| Measure | Description | Time Frame |
|---|---|---|
| At 3rd, 6th and 12th month's follow-up, to evaluate the rhythm status by ECG and 24-hour Holter and cardiac hemodynamic status by transthoracic echocardiography | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Any one of the following exclusion criteria is sufficient to disqualify a patient from the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xin Wang, MD | Contact | 86 10 15810210252 | liuyedao21st@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shengshou Hu | National center for cardiovascular disease ,china | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai cardiovascular disease hospital | Recruiting | Beijing | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24820759 | Derived | 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. |
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|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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