Persistent Atrial FibrillationNCT05125042
Catgut Embedding in Acupoints on Treating Persistent Atrial Fibrillation After Catheter Ablation
A study testing Amiodarone hydrochloride tablet + acupoint catgut embedding and Amiodarone hydrochloride tablet in people with Persistent Atrial Fibrillation, run by Shanghai Chest Hospital.
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Amiodarone hydrochloride tablet + acupoint catgut embedding and Amiodarone hydrochloride tablet
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 20 Dec 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Control Study of Catgut Embedding in Acupoint on Treating Persistent Atrial Fibrillation After Catheter Ablation: a Chinese Registry Study.
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..
Read the 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.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Amiodarone hydrochloride tablet + acupoint catgut embedding, Amiodarone hydrochloride tablet
- Keywords
- persistent atrial fibrillation after catheter ablation, catgut embedding in acupoints
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiodarone hydrochloride tablet + acupoint catgut embeddingProcedure or surgery
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.
Amiodarone hydrochloride tabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Amiodarone hydrochloride tablet + acupoint catgut embedding of Neiguan and Zusanli Receives: Procedure: Amiodarone hydrochloride tablet + acupoint catgut embedding; Drug: Amiodarone hydrochloride tablet |
| group B | Active comparator | Amiodarone hydrochloride tablet Receives: Procedure: Amiodarone hydrochloride tablet + acupoint catgut embedding; Drug: Amiodarone hydrochloride tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months after ablation
Secondary outcomes (4)
Postoperative AF recurrence rate
AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
Measured: up to 12 months after ablation
TCM symptom score scale
Measured: up to 12 months after ablation
Inflammatory index
Measured: up to 12 months after ablation
AF-specific Atrial Fibrillation Effect on QualiTy-of-life Scale
Measured: up to 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 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
- NCT05125042
- Sponsor's protocol ID
- CAAF
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 18 Nov 2021
- 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 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Study of Catgut Embedding in Acupoint on Treating Persistent Atrial Fibrillation After Catheter Ablation: a Chinese Registry Study.
- ClinicalTrials.gov ID
- NCT05125042
- Acronym / sponsor ID
- CAAF
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- persistent atrial fibrillation after catheter ablation, catgut embedding in acupoints
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 18 Nov 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: Amiodarone hydrochloride tablet + acupoint catgut embedding, Drug: Amiodarone hydrochloride tabletAmiodarone hydrochloride tablet + acupoint catgut embedding of Neiguan and Zusanli |
| group B | Active comparator | Procedure: Amiodarone hydrochloride tablet + acupoint catgut embedding, Drug: Amiodarone hydrochloride tabletAmiodarone hydrochloride tablet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Amiodarone hydrochloride tablet + acupoint catgut embeddingPatients 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. | Procedure or surgery | group A, group B |
| Amiodarone hydrochloride tabletPatients 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. | Drug | group A, group B |
Primary outcome
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
Time frame: 12 months after ablation
at 12 months (AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration).
4 secondary outcomes
Postoperative AF recurrence rate
Time frame: up to 12 months after ablation
TCM symptom score scale
Time frame: up to 12 months after ablation
Inflammatory index
Time frame: up to 12 months after ablation
AF-specific Atrial Fibrillation Effect on QualiTy-of-life Scale
Time frame: up to 12 months after ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Amiodarone hydrochloride tablet + acupoint catgut embedding and Amiodarone hydrochloride tablet in people with Persistent Atrial Fibrillation, 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 1 inclusion and 1 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 18 Nov 2021. 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?
Contact Xiyao Zhu, M.D. (+8615628783870, zhuxiyao940718@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate (time frame: 12 months after ablation). 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 18 Nov 2021.