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

Not Applicable

• Conditions: Persistent Atrial Fibrillation
• Interventions: Procedure: Amiodarone hydrochloride tablet + acupoint catgut embedding; Drug: Amiodarone hydrochloride tablet

• Registration Number: NCT05125042
• Lead Sponsor: Shanghai Chest Hospital

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.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-17
• Last Update Submitted: 2021-11-17
• Study First Posted: 2021-11-18
• Last Update Posted: 2021-11-18
• Study Start: 2021-12-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Amiodarone hydrochloride tablet	Amiodarone hydrochloride tablet + acupoint catgut embedding of Neiguan and Zusanli
group B	Amiodarone hydrochloride tablet	Amiodarone hydrochloride tablet
group A	Amiodarone hydrochloride tablet + acupoint catgut embedding	Amiodarone hydrochloride tablet + acupoint catgut embedding of Neiguan and Zusanli
group B	Amiodarone hydrochloride tablet + acupoint catgut embedding	Amiodarone hydrochloride tablet

Primary Outcome Measures

Name	Time	Method
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate	12 months after ablation	at 12 months (AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration).

Secondary Outcome Measures

Name	Time	Method
AF-specific Atrial Fibrillation Effect on QualiTy-of-life Scale	up to 12 months after ablation
TCM symptom score scale	up to 12 months after ablation
Postoperative AF recurrence rate	up to 12 months after ablation	AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
Inflammatory index	up to 12 months after ablation