Persistent Atrial Fibrillation Clinical Trial
Official title:
A Randomized Control Study of Catgut Embedding in Acupoint on Treating Persistent Atrial Fibrillation After Catheter Ablation: a Chinese Registry Study.
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..
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | December 20, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 1. Age between 18 and 80 years old; 2. Persistent AF(lasting no more than 3 years)after catheter ablation; 3. No acupuncture treatment within the previous 6 months. Exclusion Criteria: - 1. A history of allergy to acupuncture or amiodarone; 2. Severe heart failure (New York Heart Association(NYHA)class III or IV); 3. Echocardiographic parameters: left ventricular ejection fraction < 40%, left atrium diameter > 5.0cm; 4. Severe lung, liver, kidney disease or other serious primary diseases; 5. Skin allergy to ECG monitoring electrode patch. 6. The estimated life expectancy of < 1 year. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shanghai Chest Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | TCM symptom score scale | up to 12 months after ablation | ||
Secondary | Inflammatory index | up to 12 months after ablation | ||
Secondary | AF-specific Atrial Fibrillation Effect on QualiTy-of-life Scale | up to 12 months after ablation |
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