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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Amiodarone hydrochloride tablet + acupoint catgut embedding; Drug: Amiodarone hydrochloride tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05125042

CAAF

Details and patient eligibility

About

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..

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

group A

Experimental group

Description:

Amiodarone hydrochloride tablet + acupoint catgut embedding of Neiguan and Zusanli

Treatment:

Drug: Amiodarone hydrochloride tablet

Procedure: Amiodarone hydrochloride tablet + acupoint catgut embedding

group B

Active Comparator group

Description:

Amiodarone hydrochloride tablet

Treatment:

Drug: Amiodarone hydrochloride tablet

Procedure: Amiodarone hydrochloride tablet + acupoint catgut embedding