Safety and Efficacy of Paramedic Treatment of Regular Supraventricular Tachycardia

Supraventricular Tachycardia Clinical Trial

— Para-SVT  

Official title:

Safety and Efficacy of Paramedic Treatment of Regular Supraventricular Tachycardia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02216240
• Other study ID #: 005795QM
• Status: Recruiting
• Phase: N/A
• First received: August 12, 2014
• Last updated: August 12, 2014
• Start date: December 2010

Study information

• Verified date: February 2014
• Source: Barts & The London NHS Trust
• Contact: Victoria Baker, RN MSc
• Phone: 02034656763
• Email: victoria.baker[@]bartshealth.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Supraventricular

Intervention

Other:
• Paramedic

• Standard care

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	London Ambulance Service NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cumulative time from 999 call to discharge from care for each episode of arrhythmia at 6 month follow-up		6 months	No