NCT03514628: EVADE

Evaluation of the Valsalva Assist Device to Treat SVT

Completed NA Last updated 14 November 2019

What this trial tests

NA trial testing Standard Care in SVT in 34 participants. Completed in 31 December 2018.

Timeline

1 July 2018

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	South Western Ambulance Service NHS Foundation Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	34
Start date	1 July 2018
Primary completion	31 December 2018
Estimated completion	31 December 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• Standard Care — full drug profile →
• Valsalva Assist Device (VAD)

Conditions studied

• SVT — all drugs for SVT →
• Vagal Bradycardia — all drugs for Vagal Bradycardia →
• Emergencies — all drugs for Emergencies →

Sponsor

South Western Ambulance Service NHS Foundation Trust

Who can join

18 and older, any sex, with SVT or Vagal Bradycardia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Valsalva Assist Device (VAD) is a simple hand held device, designed to assist in the physical treatment of a common, fast heart rhythm disorder called supraventricular tachycardia (SVT).

This treatment, called the Valsalva manoeuvre (VM), is a safe, physical technique involving a forced exhalation against resistance (like that required to blow up a balloon). This causes a reflex slowing of the heart and can correct attacks of SVT (cardioversion). It is an internationally recommended initial treatment but previously has had a low success rate (5-27%) and patients often have to be taken to hospital for drug treatment.

Recent hospital research has demonstrated that a VM carried out using a certain level of strain pressure(40mmHg) measured with a blood pressure manometer, combined with a simple postural modification (the modified VM) gives a far better chance of success (43%) and avoids the need for drug treatment. More practical methods of generating this strain such as blowing on an empty syringe have been used but are unreliable. The Valsalva Assist Device (VAD) has been designed to provide the correct resistance and is packaged with instructions for the modified VM.

Attacks of SVT frequently occur without warning in otherwise healthy people. Patients are often initially seen by ambulance staff and so the use of the VAD therefore represents an opportunity to provide ambulance clinicians with instructions for the modified VM and a means to deliver the correct strain in one, easy to use device.

The investigators plan to test use of the device in patients with an attack of SVT and attended by paramedics or other pre-hospital practitioner, compared to current recommended practice. This project will provide important feasibility and recruitment data for a definitive trial, assessing the performance of the VAD on SVT cardioversion and conveyance (transfer to hospital) rates.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluation of pre-hospital use of a valsalva assist device in the emergency treatment of supraventricular tachycardia [EVADE]: a randomised controlled feasibility trial.
   Appelboam A, Green J, Ewings P, Black S, et al · · 2020 · cited 6× · PMID 32509319 · DOI 10.1186/s40814-020-00616-y