<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02216240</url>
  </required_header>
  <id_info>
    <org_study_id>005795QM</org_study_id>
    <nct_id>NCT02216240</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Paramedic Treatment of Regular Supraventricular Tachycardia</brief_title>
  <acronym>Para-SVT</acronym>
  <official_title>Safety and Efficacy of Paramedic Treatment of Regular Supraventricular Tachycardia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barts &amp; The London NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>London Ambulance Service NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Barts &amp; The London NHS Trust</source>
  <brief_summary>
    <textblock>
      Supraventricular tachycardia (SVT) is a term describing any rhythm coming from the top half&#xD;
      of the heart. Although atrial fibrillation is the commonest cardiac arrhythmia, regular SVT's&#xD;
      are also common. The two commonest regular SVT's are atrioventricular (nodal) reentry&#xD;
      tachycardias (AV(N)RT) and atrial flutter (AFL). Atrioventricular (nodal) reentry&#xD;
      tachycardias (AV(N)RT) are common but benign forms of fast heart rhythm. Although AV(N)RT can&#xD;
      cause unpleasant symptoms and are frightening it is not dangerous. If patients present with&#xD;
      AV(N)RT the accepted and normal treatment for most is to have the fast heart rhythm stopped&#xD;
      by either taking a deep breath and straining or by the use of drugs. Patients can then be&#xD;
      discharged home and have further investigation and treatment as an outpatient. SVT can be&#xD;
      frightening for the patient but is easy to diagnose and treat. There is high success rate&#xD;
      post treatment for this benign condition. This is traditionally done in the local accident&#xD;
      and emergency, although patients can sometimes be unnecessarily admitted to hospital&#xD;
      overnight. We propose to investigate the safety and efficacy of training paramedics to treat&#xD;
      safe forms of AV(N)RT at the scene and then giving the patient an information pack which&#xD;
      includes a request for a GP referral to a heart rhythm specialist. Patients will be randomly&#xD;
      allocated after consenting to take part in the study to either get paramedic or accident and&#xD;
      emergency department treatment. We will compare these two approaches by telephone follow up&#xD;
      of the patients. The costs of the different approaches will be compared by assessing the rate&#xD;
      of appropriate investigation and the information given to patients and how they rated their&#xD;
      experiences.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2010</start_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The cumulative time from 999 call to discharge from care for each episode of arrhythmia at 6 month follow-up</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Supraventricular Tachycardia</condition>
  <arm_group>
    <arm_group_label>Accident and emergency</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomised to A&amp;E were treated as per standard care and given no information other than that pertaining to the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paramedic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Paramedic</intervention_name>
    <arm_group_label>Paramedic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <arm_group_label>Accident and emergency</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Patients presenting with regular narrow complex tachycardia on 12 lead ECG&#xD;
&#xD;
        Exclusion Age &lt; 16 years Already enrolled in the study or another research study Syncope or&#xD;
        blackout Sinus tachycardia ECG evidence of myocardial infarction Broad Complex tachycardia&#xD;
        A history of illicit drug use within the previous 24 hours A history of structural or&#xD;
        ischaemic heart disease Inability or unwillingness to give consent Pregnancy Failure to&#xD;
        obtain intravenous access Hypotension - defined as a systolic blood pressure of &lt;100&#xD;
        systolic Contraindications to Adenosine injection Heart transplant patients Patients on&#xD;
        dipyridamole Patients on regular asthma inhalers Obvious atrial flutter&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Victoria Baker, RN MSc</last_name>
    <phone>02034656763</phone>
    <email>victoria.baker@bartshealth.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victoria Baker, RN MSc</last_name>
      <phone>02034656763</phone>
      <email>victoria.baker@bartshealth.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Supraventricular</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02216240
org study id: 005795QM
nct id: NCT02216240
lead sponsor: 
collaborator: 
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
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
arm group label: Accident and emergency
arm group type: Active Comparator
description: Patients randomised to A&E were treated as per standard care and given no information other than that pertaining to the study.
arm group label: Paramedic
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: Paramedic
arm group label: Paramedic
intervention type: Other
intervention name: Standard care
arm group label: Accident and emergency
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Victoria Baker, RN MSc
phone: 02034656763
email: victoria.baker@bartshealth.nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Tachycardia
mesh term: Tachycardia, Supraventricular