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Evaluation of the Valsalva Assist Device to Treat SVT (EVADE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514628
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : November 14, 2019
Sponsor:
Collaborators:
Royal Devon and Exeter NHS Foundation Trust
Academic Health Science Centres
Information provided by (Responsible Party):
South Western Ambulance Service NHS Foundation Trust

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. Participant recruitment [ Time Frame: At study completion (after an 8 month recruitment period) ]
    The number of participants recruited to the trial


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (above 17years)
  • Presenting with SVT which the ambulance clinician identifies as being eligible for a vagal manoeuvre

Exclusion Criteria:

  • Unable or unwilling to give informed verbal consent
  • Unstable condition (systolic blood pressure (BP) < 90mmHg) [Increased risk of feeling or actually fainting with a VM which causes a transient fall in BP as a normal physiological response]
  • Atrial fibrillation or atrial flutter on ECG [VM considered ineffective in these rhythms]
  • Severe hypertension (systolic BP >220mmHg or diastolic BP >120mmHg) [Risk of further increase in BP at end of VM - a normal physiological response]
  • Contraindication or inability to perform a modified Valsalva manoeuvre in the opinion of the practitioner. This will include but not limited to: Aortic stenosis, recent myocardial infarction, glaucoma, retinopathy and inability to perform a Valsalva manoeuvre, to lie flat or have legs lifted. [We will exclude all those that could conceivable come to any harm from performing a VM]
  • Third trimester pregnancy [Lying flat can cause fainting in late pregnancy]
  • Prisoners
  • Previous inclusion in the study

Information from the National Library of Medicine

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


Locations
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United Kingdom
29 Selected Ambulance Stations
Exeter, South West England, United Kingdom
Sponsors and Collaborators
South Western Ambulance Service NHS Foundation Trust
Royal Devon and Exeter NHS Foundation Trust
Academic Health Science Centres
Investigators
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Principal Investigator: Andrew Appelboam, MBBS, FRCEM Royal Devon & Exeter Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: South Western Ambulance Service NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03514628    
Other Study ID Numbers: 238130
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by South Western Ambulance Service NHS Foundation Trust:
Valsalva Manoeuvre
SVT
Valsalva Assist Device
Additional relevant MeSH terms:
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Bradycardia
Emergencies
Disease Attributes
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases