A Novel Valsalva Assist Device for Terminating Supraventricular Tachycardia

NCT06622772 | Completed

• 1 other identifier: KS2023109
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficiency of a device for terminating supraventricular tachycardia. The main questions it aims to answer are: The Valsalva manoeuvre is a first-line treatment for supraventricular tachycardia, but the success rate is low. Can the device help to increase the sucess rate? Whether the device is effective and safe to use at home? Researchers will compare whether the device is more effective than a standard Valsalva manoeuvre to treat supraventricular tachycardia. Participants will: be randomly assigned (1:1) to a standard Valsalva manoeuvre group (control) or Valsalva manoeuvre with the device (intervention) .

Conditions

Supraventricular Tachycardia (SVT)

Keywords

supraventricular tachycardia; Valsalva Manoeuvre

Outcome Measures

Primary Outcomes (1)

• The presence of sinus rhythm

  The primary outcome is the presence of sinus rhythm as recorded by the treating clinician 1 min after twice VM and confirmed by ECG in the intention-to-treat population.

  From enrollment to the end of treatment at 1 day.

Secondary Outcomes (1)

• The presence of sinus rhythm

  From enrollment to the end of treatment at 1day

Study Arms (2)

VAD group

EXPERIMENTAL

Valsalva manoeuvre with a valsalva assist device (VAD)

Device: Valsalva assist device

Control group

OTHER

standard Valsalva manoeuvre

Other: standard Valsalva manoeuvre

Interventions

Valsalva assist device DEVICE

A valsalva assist device designed to provide the recommended resistance to exhalation at a pressure of 40 mmHg.

VAD group

standard Valsalva manoeuvre OTHER

The Valsalva manoeuvre is carried out without any device.

Control group

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient having supraventricular tachycardia (SVT) with regular, narrow complex tachy-arrythmia with a QRS duration \< 0.12 ms on ECG and eligible for treatment with the Valsalva manoeuvre.
• AVNRT (atrioventricular nodal re-entry tachycardia) or AVRT (atrioventricular re-entry tachycardia) conformed by electrophysiologic test.

You may not qualify if:

• Unable or unwilling to give informed verbal consent.
• SVT episode with hemodynamic instability (systolic blood pressure (BP) \< 90 mmHg).
• With atrial fibrillation or atrial flutter.
• Severe hypertension (systolic BP \> 220 mmHg or diastolic BP \> 120 mmHg).
• Contraindication or inability to perform a VM (aortic stenosis, recent myocardial infarction, glaucoma, retinopathy, recent eye surgery, paralysis).
• Third trimester pregnancy.
• Previous catheter ablation of SVT.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Capital Medical University affiliated Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

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

Study Officials

• Songnan Li

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All analyses were done by statisticians masked to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 2, 2024
• Study Start: March 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 6 months after the publication of results.
• Access Criteria: A proposal that describes planned analyses must be submitted and a data sharing agreement must be signed. And the plan must be approved by Dr. Songnan Li.

Locations

CN (1)