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

Primary Purpose

Persistent Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Amiodarone hydrochloride tablet + acupoint catgut embedding
Amiodarone hydrochloride tablet
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring persistent atrial fibrillation after catheter ablation, catgut embedding in acupoints

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    group A

    group B

    Arm Description

    Amiodarone hydrochloride tablet + acupoint catgut embedding of Neiguan and Zusanli

    Amiodarone hydrochloride tablet

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Postoperative AF recurrence rate
    AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
    TCM symptom score scale
    Inflammatory index
    AF-specific Atrial Fibrillation Effect on QualiTy-of-life Scale

    Full Information

    First Posted
    November 17, 2021
    Last Updated
    November 17, 2021
    Sponsor
    Shanghai Chest Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05125042
    Brief Title
    Catgut Embedding in Acupoints on Treating Persistent Atrial Fibrillation After Catheter Ablation
    Official Title
    A Randomized Control Study of Catgut Embedding in Acupoint on Treating Persistent Atrial Fibrillation After Catheter Ablation: a Chinese Registry Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    December 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Chest Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Persistent Atrial Fibrillation
    Keywords
    persistent atrial fibrillation after catheter ablation, catgut embedding in acupoints

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Experimental
    Arm Description
    Amiodarone hydrochloride tablet + acupoint catgut embedding of Neiguan and Zusanli
    Arm Title
    group B
    Arm Type
    Active Comparator
    Arm Description
    Amiodarone hydrochloride tablet
    Intervention Type
    Procedure
    Intervention Name(s)
    Amiodarone hydrochloride tablet + acupoint catgut embedding
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Amiodarone hydrochloride tablet
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
    Description
    at 12 months (AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration).
    Time Frame
    12 months after ablation
    Secondary Outcome Measure Information:
    Title
    Postoperative AF recurrence rate
    Description
    AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
    Time Frame
    up to 12 months after ablation
    Title
    TCM symptom score scale
    Time Frame
    up to 12 months after ablation
    Title
    Inflammatory index
    Time Frame
    up to 12 months after ablation
    Title
    AF-specific Atrial Fibrillation Effect on QualiTy-of-life Scale
    Time Frame
    up to 12 months after ablation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiyao Zhu, M.D.
    Phone
    +8615628783870
    Email
    zhuxiyao940718@163.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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