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This study is aimed to compare the efficacy of bi-atrial ablation with left atrial ablation for atrial fibrillation during mitral valve surgery in patients with rheumatic mitral valve disease.
Atrial fibrillation (AF) is present in 40%-60% of patients with rheumatic mitral valve disease (RMVD), which is an independent predictor of mortality and late stroke. During mitral valve (MV) surgery, the open left atrium facilitates a bi-atrial ablation procedure. However, a simplified lesion set including isolated pulmonary vein isolation or posterior left atrial (LA) wall isolation or LA maze was usually applied. The current literatures provide insufficient evidence to determine the potential benefits of bi-atrial ablation procedure when comparing with LA ablation procrdure in patients with non-paroxysmal AF and RMVD.
Patients with RMVD often have longer history, which tends to affect the right atrium, including pulmonary hypertension or tricuspid regurgitation.The necessity of bi-atrial ablation procedure targeting the bi-atrial substrate for AF in RMVD requires to be explored. In this study, we aimed to compare the efficacy of bi-atrial ablation with LA ablation for AF during MV surgery in patients with RMVD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bi-atrial ablation group | Experimental | Participants in this group will receive mitral valve surgery concomitant with bi-atrial ablation procedure. |
|
| Left atrial ablation group | Active Comparator | Participants in this group will receive mitral valve surgery concomitant with left atrial ablation procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bi-atrial ablation | Procedure | This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs | Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring in the absence of antiarrhythmic drugs. | At 12-month after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate without permanent pacemaker implantation (Key secondary outcome) | Percentage of participants who did not have a new permanent pacemaker implanted. | At 12-month after intervention |
| Survival rate without any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhe Zheng, MD,PhD | Contact | : +86-010-88396051 | zhengzhe@fuwai.com | |
| Chunyu Yu, MD | Contact | yuchunyu@fuwai.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhe Zheng, MD,PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36446460 | Derived | Yu C, Li H, Wang Y, Chen S, Zhao Y, Zheng Z. Bi-atrial versus left atrial ablation for patients with rheumatic mitral valve disease and non-paroxysmal atrial fibrillation (ABLATION): rationale, design and study protocol for a multicentre randomised controlled trial. BMJ Open. 2022 Nov 29;12(11):e064861. doi: 10.1136/bmjopen-2022-064861. |
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| Left atrial ablation | Procedure | This intervention includes mitral valve surgery concomitant with left atrial ablation alone. |
|
Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring with antiarrhythmic drugs. |
| At 12-month after intervention |
| Burden of atrial fibrillation | Burden of atrial fibrillation according to 3-day Holter monitoring. | At 12-month after intervention |
| Major adverse events | Including cardiac death, stroke, heart failure requiring rehospitalization, embolic events or bleeding events requiring rehospitalization. | At 12-month after intervention |
| Cardiac function | Documented by echocardiography (left ventricular ejection fraction). | At 12-month after intervention |
| Nanjing First Hospital, Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
|
| 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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