Atrioventricular Reentrant TachycardiaNCT06219343
Non-invasive Left-sided Cervical Vagus Nerve Stimulation for Atrioventricular Reentrant Tachycardia
A study testing Non-invasive vagus nerve stimulation in people with Atrioventricular Reentrant Tachycardia, run by Jingye Tai at 1 site in China.
Trial summary
The goal of this Interventional clinical trials in atrioventricular reentrant tachycardia patients. The main question it aims to answer whether non-invasive vagus nerve stimulation could be effective in restoring rhythm. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atrioventricular Reentrant Tachycardia
- What is being tested?
- Non-invasive vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2023to 30 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The relevant diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Supraventricular Tachycardia (svt) need to be met.
- All need to be free of psychiatric abnormalities, verbal communication disorders, and have good compliance.
- The patients and their families gave informed consent and signed the informed consent form.
Who cannot join
- Does not meet the relevant diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Supraventricular Tachycardia (svt).
- Mental anomalies, verbal communication disorders, poor adherence
- Those who do not consent to participate in this clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ai-lan Chen
Guangzhou, Guangdong, 510000
Ai-lan Chen, Dr., 13719198832, 1228327958@qq.com
About this study
The goal of this Interventional clinical trials in atrioventricular reentrant tachycardia patients. The main question it aims to answer whether non-invasive vagus nerve stimulation could be effective in restoring rhythm.
Patients will receive non-invasive vagus nerve electrical stimulation under catheter evoked and cardiac monitoring to observe their heart rhythm changes.
Read the detailed description
Participants will be treated with non-invasive electrical stimulation of the left vagus nerve in the neck. After routine induction of atrioventricular reentrant tachycardia prior to radiofrequency ablation, the electrode patch was placed on the patient's left cervical vagal body surface localization, i.e., between the sternocleidomastoid muscle and the trachea where the left common carotid artery pulsation could be palpated, and resuscitation was performed using non-invasive electrical stimulation.
- Conditions
- Atrioventricular Reentrant Tachycardia
- Being tested
- Non-invasive vagus nerve stimulation
- Keywords
- non-invasive, vagus nerve stimulation, rapid return rhythm
- Medical subject headings
- Tachycardia, Atrioventricular Nodal Reentry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive vagus nerve stimulationDevice
Patient undergoes non-invasive vagus nerve stimulation during tachycardia episodes to see if reentry is possible
| Study group | Role | What they receive |
|---|---|---|
| Transcervical non-invasive vagus nerve stimulation group | Experimental | Patient will be treated with non-invasive electrical stimulation of the left vagus nerve in the neck. After routine induction of atrioventricular reentrant tachycardia prior to radiofrequency ablation, the electrode patch was placed on the patient's left cervical vagal body surface localization, i.e., between the sternocleidomastoid muscle and the trachea where the left common carotid artery pulsation could be palpated, and resuscitation was performed using non-invasive electrical stimulation. Receives: Device: Non-invasive vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether the tachycardia is repetitive or not
Determining whether a tachycardia is reentrant on the basis of the ambulatory electrocardiogram
Measured: 10minutes
Secondary outcomes (1)
Parameters leading to tachycardia resumption
Intensity of electrical stimuli leading to tachycardia resumption
Measured: 10minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start10 Jan 2023
- Primary completion10 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrioventricular Reentrant TachycardiaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jingye Tai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jingye Tai, Guangzhou Medical University
- Investigators
- Ai-lan Chen, Study director, The First Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219343
- Sponsor's protocol ID
- ES-2023-175-03
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Left-sided Cervical Vagus Nerve Stimulation for Atrioventricular Reentrant Tachycardia
- ClinicalTrials.gov ID
- NCT06219343
- Acronym / sponsor ID
- ES-2023-175-03
- Conditions
- Atrioventricular Reentrant Tachycardia
- Keywords
- non-invasive, vagus nerve stimulation, rapid return rhythm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jingye TaiUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 23 Jan 2024 (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.
The goal of this Interventional clinical trials in atrioventricular reentrant tachycardia patients. The main question it aims to answer whether non-invasive vagus nerve stimulation could be effective in restoring rhythm.
Patients will receive non-invasive vagus nerve electrical stimulation under catheter evoked and cardiac monitoring to observe their heart rhythm changes.
Detailed description
Participants will be treated with non-invasive electrical stimulation of the left vagus nerve in the neck. After routine induction of atrioventricular reentrant tachycardia prior to radiofrequency ablation, the electrode patch was placed on the patient's left cervical vagal body surface localization, i.e., between the sternocleidomastoid muscle and the trachea where the left common carotid artery pulsation could be palpated, and resuscitation was performed using non-invasive electrical stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcervical non-invasive vagus nerve stimulation group | Experimental | Device: Non-invasive vagus nerve stimulationPatient will be treated with non-invasive electrical stimulation of the left vagus nerve in the neck. After routine induction of atrioventricular reentrant tachycardia prior to radiofrequency ablation, the electrode patch was placed on the patient's left cervical vagal body surface localization, i.e., between the sternocleidomastoid muscle and the trachea where the left common carotid artery pulsation could be palpated, and resuscitation was performed using non-invasive electrical stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The relevant diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Supraventricular Tachycardia (svt) need to be met.
- All need to be free of psychiatric abnormalities, verbal communication disorders, and have good compliance.
- The patients and their families gave informed consent and signed the informed consent form.
Key exclusion criteria (3 listed)
- Does not meet the relevant diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Supraventricular Tachycardia (svt).
- Mental anomalies, verbal communication disorders, poor adherence
- Those who do not consent to participate in this clinical trial
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 |
|---|---|---|
| Non-invasive vagus nerve stimulationPatient undergoes non-invasive vagus nerve stimulation during tachycardia episodes to see if reentry is possible | Device | Transcervical non-invasive vagus nerve stimulation group |
Primary outcome
Whether the tachycardia is repetitive or not
Time frame: 10minutes
Determining whether a tachycardia is reentrant on the basis of the ambulatory electrocardiogram
1 secondary outcome
Parameters leading to tachycardia resumption
Time frame: 10minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Atrioventricular Reentrant Tachycardia
Not yet recruitingObservational study
Comparative Outcomes of Radiofrequency Ablation of Concealed and Manifest Accessory Pathways: a Single Center, Retrospective Observational Study
Atrioventricular Reentrant Tachycardias, Wolff-Parkinson-White (WPW) Syndrome
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.
Ai-lan Chen study director
The First Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive vagus nerve stimulation in people with Atrioventricular Reentrant Tachycardia, run by Jingye Tai at 1 site in China.
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 3 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 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ai-lan Chen (13719198832, 1228327958@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether the tachycardia is repetitive or not (time frame: 10minutes). 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 23 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.