Atrial FibrillationNCT05575544
Electroacupuncture Intervention in Catheter Ablation of Atrial Fibrillation
A study testing Acupuncture plus morphine in people with Atrial Fibrillation and Catheter Ablation, run by Shanghai Chest Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Catheter Ablation
- What is being tested?
- Acupuncture plus morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 11 Oct 2022to 13 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years old;
- Atrial fibrillation
- Nonresponse or intolerance to ≥1 antiarrhythmic drug.
Who cannot join
- 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;
Show all 12Show fewer
- 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
About this study
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.
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
- Being tested
- Acupuncture plus morphine
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture plus morphineProcedure or surgery
The acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure
| Study group | Role | What they receive |
|---|---|---|
| Left PVI ablation electroacupuncture group | Experimental | 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. Receives: Procedure: Acupuncture plus morphine |
| Right PVI ablation electroacupuncture group | Experimental | 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. Receives: Procedure: Acupuncture plus morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 month after enrollment
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.
Measured: up to 1 month after enrollment
Secondary outcomes (4)
The dose of morphine used during the catheter ablation procedure
To compare the dose of morphine used during pulmonary vein isolation procedure.
Measured: up to 1 month after enrollment
the change of blood pressure during the catheter ablation procedure
Record the changes of blood pressure during the catheter ablation procedure
Measured: up to 1 months after enrollment
Change of the the radio of IL6/IL10 before and after the ablation procedure
Measured: up to 1 months after enrollment
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
Measured: up to 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start11 Oct 2022 (estimated)
- Primary completion11 Oct 2023 (estimated)
- Study completion13 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575544
- Sponsor's protocol ID
- EAAF
- Status last verified
- Oct 2022
- First submitted
- 23 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05575544
- Acronym / sponsor ID
- EAAF
- Conditions
- Atrial Fibrillation, Catheter Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 11 Oct 2022 (estimated)
- Primary completion
- 11 Oct 2023 (estimated)
- Study completion
- 13 Oct 2023 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left PVI ablation electroacupuncture group | Experimental | Procedure: Acupuncture plus morphinePatient 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. |
| Right PVI ablation electroacupuncture group | Experimental | Procedure: Acupuncture plus morphinePatient 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 80 years old;
- Atrial fibrillation
- Nonresponse or intolerance to ≥1 antiarrhythmic drug.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture plus morphineThe acupuncture was combined with intravenous use of morphine to achieve anesthesia during the ablation procedure | Procedure or surgery | Left PVI ablation electroacupuncture group, Right PVI ablation electroacupuncture group |
Primary outcome
The severity of intraprocedural pain during the catheter ablation procedure
Time frame: up to 1 month after enrollment
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
Time frame: up to 1 month after enrollment
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.
4 secondary outcomes
The dose of morphine used during the catheter ablation procedure
Time frame: up to 1 month after enrollment
the change of blood pressure during the catheter ablation procedure
Time frame: up to 1 months after enrollment
Change of the the radio of IL6/IL10 before and after the ablation procedure
Time frame: up to 1 months after enrollment
Incidence of complications
Time frame: up to 6 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture plus morphine in people with Atrial Fibrillation and Catheter Ablation, run by Shanghai Chest Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of intraprocedural pain during the catheter ablation procedure (time frame: up to 1 month after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.