Catgut Embedding in Acupoints on Treating Persistent Atrial Fibrillation After Catheter Ablation

Study Overview
=================
Brief Summary
-----------------
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..

Detailed Description
-----------------
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.

Official Title
-----------------
A Randomized Control Study of Catgut Embedding in Acupoint on Treating Persistent Atrial Fibrillation After Catheter Ablation: a Chinese Registry Study.

Conditions
-----------------
Persistent Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Amiodarone hydrochloride tablet + acupoint catgut embedding
* Drug: Amiodarone hydrochloride tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>Amiodarone hydrochloride tablet + acupoint catgut embedding of Neiguan and Zusanli | Procedure: Amiodarone hydrochloride tablet + acupoint catgut embedding<br>* 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.<br>Drug: Amiodarone hydrochloride tablet<br>* 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.<br>|
| Active Comparator: group B<br>Amiodarone hydrochloride tablet | Procedure: Amiodarone hydrochloride tablet + acupoint catgut embedding<br>* 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.<br>Drug: Amiodarone hydrochloride tablet<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Inflammatory index |  | up to 12 months after ablation | 
| AF-specific Atrial Fibrillation Effect on QualiTy-of-life Scale |  | up to 12 months after ablation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
persistent atrial fibrillation after catheter ablation, catgut embedding in acupoints