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The goal of this clinical trial is to compare the rhythm control effect in hypertrophic non-obstructive patients with non-paroxysmal atrial fibrillation by either concomitant catheter endocardial and thoracoscopic epicardial ablation or catheter ablation alone. The study aims to see if concomitant hybrid ablation can more effectively achieve rhythm control effect than catheter ablation alone in non-paroxysmal atrial fibrillation patients with hypertrophic cardiomyopathy.
After informed consent, 66 eligible admissions will be recruited in 2 centers. Eligible participants will be randomly divided (1:1) into either hybrid or catheter ablation arms, looking for a primary outcome of 1-year freedom from atrial arrhythmias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hybrid ablation | Experimental | Participants in this group will receive concomitant thoracoscopic epicardial ablation and catheter endocardial ablation |
|
| catheter ablation | Active Comparator | Participants in this group will receive catheter endocardial ablation only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hybrid ablation | Procedure | simultaneous thoracoscopic epicardial and catheter endocardial ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from documented recurrence (off-AADs) | freedom from documented AF/AT episodes >30 seconds (off-AADs) by 72-hour holter monitoring | within 3-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | death by any reason | within 12 months |
| Cardiovascular related mortality | death that related to cardiogenic causes |
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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 | |
| Yajie Tang, MD.PhD | Contact | +8618813019554 | tangyajietangyajie@126.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, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39384237 | Derived | Tang Y, Li L, Chen S, Xue Y, Guo H, Song L, Tang M, Yao Y, Zheng Z. Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial. BMJ Open. 2024 Oct 9;14(10):e089284. doi: 10.1136/bmjopen-2024-089284. |
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| catheter ablation | Procedure | catheter endocardial ablation |
|
| within 12 months |
| Cerebral infarction/ischemia | Any stroke or TIA diagnosed in the clinical record after the completion of the intervention | within 12 months |
| Periferal arterial embolism | Periferal arterial embolism | within 12 months |
| All-cause rehospitalization | Rehospitalized by any reason | within 3-12 months |
| Heart failure related rehospitalization | Rehospitalized by the cause of heart failure episode | within 3-12 months |
| Freedom from documented recurrence (on-AADs) | freedom from documented AF/AT episodes >30 seconds (on-AADs) by 72-hour holter monitoring | within 3-12 months |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009202 | Cardiomyopathies |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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