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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05125042
Other study ID # CAAF
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date December 20, 2023

Study information

Verified date November 2021
Source Shanghai Chest Hospital
Contact Xiyao Zhu, M.D.
Phone +8615628783870
Email zhuxiyao940718@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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..


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Amiodarone hydrochloride tablet + acupoint catgut embedding
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.
Drug:
Amiodarone hydrochloride tablet
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Chest Hospital

Outcome

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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