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Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation

Primary Purpose

Atrial Fibrillation, Catheter Ablation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture plus morphine
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

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

Inclusion Criteria:

  1. Aged 18 to 80 years old;
  2. Atrial fibrillation
  3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion Criteria:

  1. A history of allergy to acupuncture;
  2. With uncontrolled congestive heart failure;
  3. Having significant valvular disease;
  4. Having moderate-to-severe pulmonary hypertension;
  5. With myocardial infarction or stroke within 6 months of screening;
  6. With Significant congenital heart disease;
  7. Ejection fraction was <40% measured by echocardiography;
  8. Allergic to contrast media;
  9. Contraindication to anticoagulation medications;
  10. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
  11. Left atrial thrombus;
  12. Having any contraindication to right or left sided heart catheterization

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Left PVI ablation electroacupuncture group

    Right PVI ablation electroacupuncture group

    Arm Description

    Patient undergo right pulmonary vein isolation under general anesthesia.After successful isolation of the right pulmonary vein, use a 25-gauge stainless steel millineedle of different lengths to be ordered sequentially according to the acupuncture point prescription.Acupuncture was performed at Hegu and Neiguan points on the left side of the patient.After the manual acupuncture, the point was continuously stimulated by an electrical stimulator to analgesia,the frequency is 200 times / min, the pulse frequency is 3 ~ 4Hz. The output intensity is subject to the patient's tolerance, generally 20mA.The electroneedle stimulates until the end of the left pulmonary vein isolation.

    Patient undergo left pulmonary vein isolation under general anesthesia.After successful isolation of the left pulmonary vein, use a 25-gauge stainless steel millineedle of different lengths to be ordered sequentially according to the acupuncture point prescription.Acupuncture was performed at Hegu and Neiguan points on the left side of the patient.After the manual acupuncture, the point was continuously stimulated by an electrical stimulator to analgesia,the frequency is 200 times / min, the pulse frequency is 3 ~ 4Hz. The output intensity is subject to the patient's tolerance, generally 20mA.The electroneedle stimulates until the end of the right pulmonary vein isolation.

    Outcomes

    Primary Outcome Measures

    The severity of intraprocedural pain during the catheter ablation procedure
    Pain was assessed by Visual Analogue Score (VAS).VAS is one of the commonly used pain scoring standards. The full name is the visual simulation scoring method. The pain is divided into 10 points, 2 points for no pain, 10 points for severe pain, and the middle part for different degrees of pain.To compare the scores of patients during pulmonary vein isolation procedure.
    The severity of intraprocedural nausea during the catheter ablation procedure
    The incidence of nausea, vomiting and retching within 12 hours after operation was recorded, including 3 dimensions of symptom experience time, frequency and severity, with 8 items in total. 0~4 points shall be used for 5 grades. 0 points means none at all, and 4 points means very serious and intolerable.

    Secondary Outcome Measures

    The dose of morphine used during the catheter ablation procedure
    To compare the dose of morphine used during pulmonary vein isolation procedure.
    the change of blood pressure during the catheter ablation procedure
    Record the changes of blood pressure during the catheter ablation procedure
    Change of the the radio of IL6/IL10 before and after the ablation procedure
    Incidence of complications
    death, atrio-esophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, left atrial thrombus, pericarditis and major vascular access complication or bleeding

    Full Information

    First Posted
    September 23, 2022
    Last Updated
    October 8, 2022
    Sponsor
    Shanghai Chest Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05575544
    Brief Title
    Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation
    Official Title
    A Randomized Control Trial to Determine Whether Electroacupuncture(EA) Intervention With Morphine Can Reduce the Intraoperative Pain and Early Post-operative Complications in Patients Undergoing Catheter Ablation of Atrial Fibrillation.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 11, 2022 (Anticipated)
    Primary Completion Date
    October 11, 2023 (Anticipated)
    Study Completion Date
    October 13, 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 randomized control trial to determine whether electroacupuncture(EA) intervention with Morphine can reduce the intraoperative pain and early post-operative complications in patients undergoing catheter ablation of atrial fibrillation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Catheter Ablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Left PVI ablation electroacupuncture group
    Arm Type
    Experimental
    Arm Description
    Patient undergo right pulmonary vein isolation under general anesthesia.After successful isolation of the right pulmonary vein, use a 25-gauge stainless steel millineedle of different lengths to be ordered sequentially according to the acupuncture point prescription.Acupuncture was performed at Hegu and Neiguan points on the left side of the patient.After the manual acupuncture, the point was continuously stimulated by an electrical stimulator to analgesia,the frequency is 200 times / min, the pulse frequency is 3 ~ 4Hz. The output intensity is subject to the patient's tolerance, generally 20mA.The electroneedle stimulates until the end of the left pulmonary vein isolation.
    Arm Title
    Right PVI ablation electroacupuncture group
    Arm Type
    Experimental
    Arm Description
    Patient undergo left pulmonary vein isolation under general anesthesia.After successful isolation of the left pulmonary vein, use a 25-gauge stainless steel millineedle of different lengths to be ordered sequentially according to the acupuncture point prescription.Acupuncture was performed at Hegu and Neiguan points on the left side of the patient.After the manual acupuncture, the point was continuously stimulated by an electrical stimulator to analgesia,the frequency is 200 times / min, the pulse frequency is 3 ~ 4Hz. The output intensity is subject to the patient's tolerance, generally 20mA.The electroneedle stimulates until the end of the right pulmonary vein isolation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Acupuncture plus morphine
    Intervention Description
    The acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure
    Primary Outcome Measure Information:
    Title
    The severity of intraprocedural pain during the catheter ablation procedure
    Description
    Pain was assessed by Visual Analogue Score (VAS).VAS is one of the commonly used pain scoring standards. The full name is the visual simulation scoring method. The pain is divided into 10 points, 2 points for no pain, 10 points for severe pain, and the middle part for different degrees of pain.To compare the scores of patients during pulmonary vein isolation procedure.
    Time Frame
    up to 1 month after enrollment
    Title
    The severity of intraprocedural nausea during the catheter ablation procedure
    Description
    The incidence of nausea, vomiting and retching within 12 hours after operation was recorded, including 3 dimensions of symptom experience time, frequency and severity, with 8 items in total. 0~4 points shall be used for 5 grades. 0 points means none at all, and 4 points means very serious and intolerable.
    Time Frame
    up to 1 month after enrollment
    Secondary Outcome Measure Information:
    Title
    The dose of morphine used during the catheter ablation procedure
    Description
    To compare the dose of morphine used during pulmonary vein isolation procedure.
    Time Frame
    up to 1 month after enrollment
    Title
    the change of blood pressure during the catheter ablation procedure
    Description
    Record the changes of blood pressure during the catheter ablation procedure
    Time Frame
    up to 1 months after enrollment
    Title
    Change of the the radio of IL6/IL10 before and after the ablation procedure
    Time Frame
    up to 1 months after enrollment
    Title
    Incidence of complications
    Description
    death, atrio-esophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, left atrial thrombus, pericarditis and major vascular access complication or bleeding
    Time Frame
    up to 6 months after enrollment

    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: Aged 18 to 80 years old; Atrial fibrillation Nonresponse or intolerance to ≥1 antiarrhythmic drug. Exclusion Criteria: A history of allergy to acupuncture; With uncontrolled congestive heart failure; Having significant valvular disease; Having moderate-to-severe pulmonary hypertension; With myocardial infarction or stroke within 6 months of screening; With Significant congenital heart disease; Ejection fraction was <40% measured by echocardiography; Allergic to contrast media; Contraindication to anticoagulation medications; Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD); Left atrial thrombus; Having any contraindication to right or left sided heart catheterization

    12. IPD Sharing Statement

    Learn more about this trial

    Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation

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