Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Atrial Fibrillation; Catheter Ablation

Treatments: Procedure: Acupuncture plus morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT05575544

EAAF

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Left PVI ablation electroacupuncture group

Experimental group

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.

Treatment:

Procedure: Acupuncture plus morphine

Right PVI ablation electroacupuncture group

Experimental group

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.

Treatment:

Procedure: Acupuncture plus morphine