Supraventricular TachycardiaPara-SVTNCT02216240
Safety and Efficacy of Paramedic Treatment of Regular Supraventricular Tachycardia
A study testing Paramedic in people with Supraventricular Tachycardia, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Supraventricular Tachycardia
- What is being tested?
- Paramedic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Dec 2010to 1 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Supraventricular Tachycardia
- Being tested
- Paramedic, Standard care
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParamedicOther
Standard careOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Paramedic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative time from 999 call to discharge from care for each episode of arrhythmia at 6 month follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study start5 Dec 2010
- Primary completion1 Jan 2015
- Study completion1 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- London Ambulance Service NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216240
- Sponsor's protocol ID
- 005795QM
- Acronym
- Para-SVT
- Status last verified
- Jan 2025
- First submitted
- 12 Aug 2014
- Last updated
- 9 Jan 2025
- Results posted
- No
Publications
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.
PubMed 27613170
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Paramedic Treatment of Regular Supraventricular Tachycardia
- ClinicalTrials.gov ID
- NCT02216240
- Acronym / sponsor ID
- Para-SVT / 005795QM
- Conditions
- Supraventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- London Ambulance Service NHS Trust
- Study start
- 5 Dec 2010 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accident and emergency | Active comparator | Other: Standard carePatients randomised to A\&E were treated as per standard care and given no information other than that pertaining to the study. |
| Paramedic | Experimental | Other: ParamedicTreatment 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paramedic | Other | Paramedic |
| Standard care | Other | Accident and emergency |
Primary outcome
The cumulative time from 999 call to discharge from care for each episode of arrhythmia at 6 month follow-up
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Derived from this study: PubMed 27613170Honarbakhsh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paramedic in people with Supraventricular Tachycardia, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cumulative time from 999 call to discharge from care for each episode of arrhythmia at 6 month follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02216240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.