Evaluation of the Valsalva Assist Device to Treat SVT (EVADE)
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|ClinicalTrials.gov Identifier: NCT03514628|
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : November 14, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|SVT Vagal Bradycardia Emergencies||Other: Standard Care Device: Valsalva Assist Device (VAD)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 randomisation to VAD or standard care|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Data analysis and determination of primary outcome will be done blind to allocation|
|Official Title:||Evaluation of Pre-hospital Use of a Valsalva Assist Devise (VAD) in the Emergency Treatment of Supraventricular Tachycardia (SVT). A Randomised Controlled Feasibility Trial [EVADE]|
|Actual Study Start Date :||July 1, 2018|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Experimental: Valsalva Assist Device (VAD)
Intervention is the use of Valsalva Assist Device (VAD) to deliver the Valsalva strain
Device: Valsalva Assist Device (VAD)
Use of Valsalva Assist Device (VAD) to generate VM
Active Comparator: Standard Care
Intervention is the use of Standard technique to deliver Valsalva strain eg blowing on empty syringe
Other: Standard Care
The Valsalva strain will be produced using Standard Care techniques
- Clinician recruitment [ Time Frame: At study completion (after an 8 month recruitment period) ]A key measures for this pilot project will be the rate of ambulance clinician recruitment.
- Participant recruitment [ Time Frame: At study completion (after an 8 month recruitment period) ]The number of participants recruited to the trial
- Cardioversion rates [ Time Frame: At study completion (after an 8 month recruitment period) ]The proportion of participants who are returned to sinus rhythm as determined by ambulance ECG after the VM. The primary outcome in the definitive study will be return to sinus rhythm after paramedic Valsalva manoeuvre attempts as determined by the treating ambulance clinician and confirmed by evidence from the ePCR such as 12 lead ECG s. This project will assess the feasibility of capturing this outcome measure.
- Conveyance rates [ Time Frame: At study completion (after an 8 month recruitment period) ]The proportion of participants who are conveyed to hospital. This will be an alternative primary outcome in the definitive study and so this project will also assess the feasibility of capturing this outcome measure.
- Completeness of data [ Time Frame: At study completion (after an 8 month recruitment period) ]The proportion of all data fields available and completed at the end of the study. Availability and completeness of all data
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514628
|29 Selected Ambulance Stations|
|Exeter, South West England, United Kingdom|
|Principal Investigator:||Andrew Appelboam, MBBS, FRCEM||Royal Devon & Exeter Hospital|