Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation

NCT ID: NCT05575544

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2023-10-13

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.

Conditions

Atrial Fibrillation; Catheter Ablation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Left PVI ablation electroacupuncture group

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.

Group Type: EXPERIMENTAL

Acupuncture plus morphine

Intervention Type: PROCEDURE

The acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure

Right PVI ablation electroacupuncture group

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.

Group Type: EXPERIMENTAL

Acupuncture plus morphine

Intervention Type: PROCEDURE

The acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure

Interventions

Acupuncture plus morphine

The acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu Liu

Professor, deputy director of cardiology department of Shanghai Chest Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EAAF

Identifier Type: -

Identifier Source: org_study_id