NCT02216240

Brief Summary

Supraventricular tachycardia (SVT) is a term describing any rhythm coming from the top half of the heart. Although atrial fibrillation is the commonest cardiac arrhythmia, regular SVT's are also common. The two commonest regular SVT's are atrioventricular (nodal) reentry tachycardias (AV(N)RT) and atrial flutter (AFL). Atrioventricular (nodal) reentry tachycardias (AV(N)RT) are common but benign forms of fast heart rhythm. Although AV(N)RT can cause unpleasant symptoms and are frightening it is not dangerous. If patients present with AV(N)RT the accepted and normal treatment for most is to have the fast heart rhythm stopped by either taking a deep breath and straining or by the use of drugs. Patients can then be discharged home and have further investigation and treatment as an outpatient. SVT can be frightening for the patient but is easy to diagnose and treat. There is high success rate post treatment for this benign condition. This is traditionally done in the local accident and emergency, although patients can sometimes be unnecessarily admitted to hospital overnight. We propose to investigate the safety and efficacy of training paramedics to treat safe forms of AV(N)RT at the scene and then giving the patient an information pack which includes a request for a GP referral to a heart rhythm specialist. Patients will be randomly allocated after consenting to take part in the study to either get paramedic or accident and emergency department treatment. We will compare these two approaches by telephone follow up of the patients. The costs of the different approaches will be compared by assessing the rate of appropriate investigation and the information given to patients and how they rated their experiences.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2010

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

4.1 years

First QC Date

August 12, 2014

Last Update Submit

January 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The cumulative time from 999 call to discharge from care for each episode of arrhythmia at 6 month follow-up

    6 months

Study Arms (2)

Accident and emergency

ACTIVE COMPARATOR

Patients randomised to A\&E were treated as per standard care and given no information other than that pertaining to the study.

Other: Standard care

Paramedic

EXPERIMENTAL

Treatment at the scene by a paramedic. Valsalva manoeuvre with subsequent administration of 6mg and 12mg of adenosine unless the supraventricular tachycardia terminated. Patients were taken to accident and emergency if the tachycardia did not terminate, restarted, or the patient had continuing symptoms, a persistently abnormal ECG (other than T wave inversion) or was heamodynamically unstable. Prior to discharge from the ambulance patients received an information pack and a referral letter for their GP to refer them to an arrhythmia clinic.

Other: Paramedic

Interventions

Paramedic
Accident and emergency

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Inclusion Patients presenting with regular narrow complex tachycardia on 12 lead ECG Exclusion Age \< 16 years Already enrolled in the study or another research study Syncope or blackout Sinus tachycardia ECG evidence of myocardial infarction Broad Complex tachycardia A history of illicit drug use within the previous 24 hours A history of structural or ischaemic heart disease Inability or unwillingness to give consent Pregnancy Failure to obtain intravenous access Hypotension - defined as a systolic blood pressure of \<100 systolic Contraindications to Adenosine injection Heart transplant patients Patients on dipyridamole Patients on regular asthma inhalers Obvious atrial flutter

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

Related Publications (1)

  • Honarbakhsh S, Baker V, Kirkby C, Patel K, Robinson G, Antoniou S, Richmond L, Ullah W, Hunter RJ, Finlay M, Earley MJ, Whitbread M, Schilling RJ. Safety and efficacy of paramedic treatment of regular supraventricular tachycardia: a randomised controlled trial. Heart. 2017 Sep;103(18):1413-1418. doi: 10.1136/heartjnl-2016-309968. Epub 2016 Sep 9.

MeSH Terms

Conditions

Tachycardia, Supraventricular

Interventions

ParamedicsStandard of Care

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Allied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and ServicesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 13, 2014

Study Start

December 5, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations