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

NCT05125042 | Unknown

• 1 other identifier: CAAF
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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..

Conditions

Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillation after catheter ablation; catgut embedding in acupoints

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Postoperative AF recurrence rate

  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

Study Arms (2)

group A

EXPERIMENTAL

Amiodarone hydrochloride tablet + acupoint catgut embedding of Neiguan and Zusanli

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

group B

ACTIVE COMPARATOR

Amiodarone hydrochloride tablet

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

Interventions

Amiodarone hydrochloride tablet + acupoint catgut embedding PROCEDURE

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.

group A; group B

Amiodarone hydrochloride tablet DRUG

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.

group A; group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Xiyao Zhu, M.D.

CONTACT

+8615628783870; zhuxiyao940718@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, deputy director of cardiology department of Shanghai Chest Hospital

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 18, 2021
• Study Start: December 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 20, 2023
• Last Updated: November 18, 2021

Record last verified: 2021-11