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This is a multi-center, 2-arm, assessor and statistician blinded, pilot randomized controlled trial, to evaluate the effect of catgut embedding in acupoints of Neiguan and Zusanli in reducing early recurrence and improving long-term prognosis in patients with persistent AF after CA..
This multi-center, 2-arm, assessor and statistician blinded, pilot randomized controlled trial will be conducted at two centers in China: Shanghai Chest Hospital; The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine. Patients with persistent atrial fibrillation after catheter ablation are 1:1 randomized into group A (amiodarone hydrochloride tablet + acupoint catgut embedding), group B (amiodarone hydrochloride tablet). ECG, inflammatory cytokines,AFEQT scale and other indicators are analyzed the effect of catgut embedding in acupoints of Neiguan and Zusanli in reducing early recurrence and improving long-term prognosis in patients with persistent AF after CA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | Amiodarone hydrochloride tablet + acupoint catgut embedding of Neiguan and Zusanli |
|
| group B | Active Comparator | Amiodarone hydrochloride tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amiodarone hydrochloride tablet + acupoint catgut embedding | Procedure | Patients with persistent AF after undergoing catheter ablation take receive acupoint catgut embedding in Neiguan and Zusanli twice after and one month after surgery combined with amiodarone hydrochloride tablets 200mg bid, 1 month; 200mg qd,maintained to 3 months.All patients, who had no signs of recurrence three months after surgery, stopped taking medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate | at 12 months (AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration). | 12 months after ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative AF recurrence rate | AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration | up to 12 months after ablation |
| TCM symptom score scale | up to 12 months after ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiyao Zhu, M.D. | Contact | +8615628783870 | zhuxiyao940718@163.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Amiodarone hydrochloride tablet | Drug | Patients with persistent AF after undergoing catheter ablation only take amiodarone hydrochloride tablets 200mg bid, 1 month; 200mg qd,maintained to 3 months.All patients, who had no signs of recurrence three months after surgery, stopped taking medication. |
|
| Inflammatory index | up to 12 months after ablation |
| AF-specific Atrial Fibrillation Effect on QualiTy-of-life Scale | up to 12 months after ablation |
| D013568 |
| Pathological Conditions, Signs and Symptoms |