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A study to determine whether introducing a Valsalva assist device into normal ambulance service care can reduce the number of patients with supraventricular tachycardia who need to be taken to hospital.

Evaluation of Pre-hospital use of a Valsalva Assist Device (VAD) in the Emergency treatment of supraventricular tachycardia (SVT). A definitive stepped-wedge cluster randomised controlled trial [EVADE SVT]

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16145266
Enrollment
800
Registered
2022-03-24
Start date
2022-07-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency treatment of supraventricular tachycardia (SVT) Circulatory System

Interventions

The stepped wedge randomised introduction of a single-patient use Valsalva assist device (VAD) for the routine treatment of SVT by ambulance clinicians. This will be compared to current standard metho

Sponsors

South Western Ambulance Service NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult patients (above 17 years) 2. Record of a Valsalva manoeuvre for presumed supraventricular tachycardia having been delivered by an ambulance clinician asigned to an ambulance station cluster.

Exclusion criteria

Exclusion criteria: 1. Subsequent withdrawal of patient consent to use data 2. Data from participants who are prisoners at the time of treatment 3. Patients with permanent lack of capacity as recorded by the treating clinician 4. Patients solely treated by a SWASFT resource not from one of the included ambulance station clusters e.g. Air Ambulance, Hazardous Area Response Team, Tiverton Minor Injuries Unit, British Association for Immediate Care (BASICS) Doctor 5. Data from patients previously included in the study will be excluded from the primary analysis but will be used in other secondary analyses 6. Patients who have previously registered with the National Data Opt-out service

Design outcomes

Primary

MeasureTime frame
Conveyance of patient to hospital as recorded in the Electronic Patient Care Record (ePCR)

Secondary

MeasureTime frame
As recorded in the Electronic Patient Care Record (ePCR): 1. The number of VM attempts used 2. Confirmation of Valsalva strain method used 3. Any evidence of postural modification to the VM 4. Cardioversion (return to normal heart rhythm) as recorded by the treating ambulance clinician (including spontaneous cardioversion) 5. Total time of the ambulance episode 6. Further ambulance attendance for SVT including subsequent conveyance to hospital (to rule out the possibility that treatment simply postpones attendance to hospital) for the duration of the trial and 3 months thereafter. 7. Compliance with SWASFT conveyance guidelines 8. Ambulance attendance for any reason within 30 days of index presentation (safety monitoring) 9. Demographic data to ensure the two trial arms are similar with respect to participant characteristics and that all patient groups, commensurate with the local population demographic, have the opportunity to take part in the research 10. Estimate of diagnostic appropriateness (through the retrospective expert reading of available, interpretable pre-Valsalva ECG traces as recorded in the ePCR). Traces with severe interference will be excluded and all other Traces will be classified as: Rhythm Eligible for a VM (eg re-entrant SVT, undetermined SVT) or Rhythm Ineligible for VM (eg atrial fibrillation, atrial flutter, sinus tachycardia) 11. Quality of life questionnaire (EQ5D) data from the optional online link, where available

Countries

England, United Kingdom

Contacts

Public ContactRia Osborne
ria.osborne@swast.nhs.uk+44 7766 633152

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026