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

NCT06219343 | Unknown

• 1 other identifier: ES-2023-175-03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. Patients will receive non-invasive vagus nerve electrical stimulation under catheter evoked and cardiac monitoring to observe their heart rhythm changes.

Conditions

Atrioventricular Reentrant Tachycardia

Keywords

non-invasive; vagus nerve stimulation; rapid return rhythm

Outcome Measures

Primary Outcomes (1)

• Whether the tachycardia is repetitive or not

  Determining whether a tachycardia is reentrant on the basis of the ambulatory electrocardiogram

  10minutes

Secondary Outcomes (1)

• Parameters leading to tachycardia resumption

  10minutes

Study Arms (1)

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.

Device: Non-invasive vagus nerve stimulation

Interventions

Non-invasive vagus nerve stimulation DEVICE

Patient undergoes non-invasive vagus nerve stimulation during tachycardia episodes to see if reentry is possible

Transcervical non-invasive vagus nerve stimulation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jingye Tai: lead

Study Sites (1)

Ai-lan Chen

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Tachycardia, Atrioventricular Nodal Reentry

Condition Hierarchy (Ancestors)

Tachycardia, Reciprocating; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ai-lan Chen

  The First Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Ai-lan Chen

CONTACT

13719198832; 1228327958@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 23, 2024
• Study Start: January 10, 2023
• Primary Completion: December 10, 2024
• Study Completion: December 30, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)