Non-invasive Left-sided Cervical Vagus Nerve Stimulation for Atrioventricular Reentrant Tachycardia

January 12, 2024 updated by: Jingye Tai

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Ai-lan Chen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The relevant diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Supraventricular Tachycardia (svt) need to be met.
  2. All need to be free of psychiatric abnormalities, verbal communication disorders, and have good compliance.
  3. The patients and their families gave informed consent and signed the informed consent form.

Exclusion Criteria:

  1. Does not meet the relevant diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Supraventricular Tachycardia (svt).
  2. Mental anomalies, verbal communication disorders, poor adherence
  3. Those who do not consent to participate in this clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcervical non-invasive vagus nerve stimulation group
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.
Device: Non-invasive vagus nerve stimulation
Patient undergoes non-invasive vagus nerve stimulation during tachycardia episodes to see if reentry is possible

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whether the tachycardia is repetitive or not
Time Frame: 10minutes
Determining whether a tachycardia is reentrant on the basis of the ambulatory electrocardiogram
10minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parameters leading to tachycardia resumption
Time Frame: 10minutes
Intensity of electrical stimuli leading to tachycardia resumption
10minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jingye Tai

Investigators

  • Study Director: Ai-lan Chen, The First Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Estimated)

December 10, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

December 27, 2023

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Estimated)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES-2023-175-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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