<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/NCT03813446</url>
  </required_header>
  <id_info>
    <org_study_id>2016RAK01</org_study_id>
    <nct_id>NCT03813446</nct_id>
  </id_info>
  <brief_title>Detection of Heart Rhythm and BP With RhythmPadBP</brief_title>
  <acronym>SLAF-BP</acronym>
  <official_title>A Study to Evaluate the Effectiveness of a Novel Device, the RhythmPadBP, in Accurately Detecting Heart Rhythm and Recording Blood Pressure Simultaneously</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiocity Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiocity Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess a new device, the RhythmPadBP, which detects heart rhythm and measure&#xD;
      blood pressure simply by placing palms of the hands on a pad containing titanium electrodes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Normally the way a doctor will assess the rhythm of the heart involves asking for an&#xD;
      electrocardiogram (ECG) which involves having to remove clothing, and sometimes shaving hair.&#xD;
      10 different leads are attached to stickers that are placed on the chest, and other parts of&#xD;
      the body. This is known as a 12-lead ECG and is the standard way that heart-rhythm problems&#xD;
      are first investigated. The usual method of measuring blood pressure (BP) involves wrapping a&#xD;
      cuff around the arm and inflating it to enough to measure the BP. The reading is then&#xD;
      displayed on a monitor. This can sometimes be uncomfortable and is often time consuming,&#xD;
      particularly in busy clinical settings.&#xD;
&#xD;
      Recent advances in technology however have given us different ways of gaining some of the&#xD;
      same information given by a 12 lead ECG and the standard BP apparatus, using much easier to&#xD;
      use devices. One of these devices is the RhythmPadBP system by Cardiocity TM. This is a&#xD;
      device where participants can record the underlying heart rhythm and BP readings simply by&#xD;
      placing palms of both hands on the device. This device does not require removal of clothing&#xD;
      or placing a BP cuff around arm and so the readings can be gained more rapidly and with&#xD;
      greater convenience.&#xD;
&#xD;
      Investigators propose to test this device to assess how accurately it recognises the most&#xD;
      common cardiac rhythm disturbances, e.g. atrial fibrillation (AF), and also measures the&#xD;
      blood pressure. This will help to identify AF and any difference of BP in both arms.&#xD;
&#xD;
      AF is an independent risk factor for stroke and increases the risk of stroke by five-fold. A&#xD;
      discrepancy of BP in both arms can be a sign of blood vessel disease and is linked to&#xD;
      increased risk of cardiovascular and cerebrovascular disease. If investigators find that this&#xD;
      device is correctly recording AF and BP, it may give us another simpler way of diagnosing AF&#xD;
      and BP discrepancies on both sides.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2017</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosis of Atrial Fibrillation</measure>
    <time_frame>18 months</time_frame>
    <description>The diagnosis of Atrial Fibrillation will be achieved through Cardiologist review of p-waves and QRS complexes on both a 1 lead and a 12 lead ECG conducted at the time of study for each participant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of BP in both arms with standard BP apparatus Vs RhythmPad BP recordings</measure>
    <time_frame>18 months</time_frame>
    <description>Measurement of blood pressure simultaneously from both arms comparing the two procedures. Both systolic and diastolic blood pressure will be recorded.</description>
  </secondary_outcome>
  <enrollment type="Actual">1100</enrollment>
  <condition>Atrial Fibrillation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Device: RhythmPadBP</intervention_name>
    <description>Detection of heart rhythm and measurement of blood pressure&#xD;
Intervention:&#xD;
Patients will start by wearing a consumer SmartWatch (Huwaei SmartWatch 2, which has a CE mark) and a 60 second reading of their wrist Photoplethysmyograph (PPG) will be recorded. This will enable us to compare the PPG from the wrist with the fingertip data collected from the RhythmPadBP.&#xD;
The watch will be cleaned with alcohol wipe in the same manner that the RhythmPadBP is cleaned between subjects use.&#xD;
Patients will be asked to place their palms of both hands on RhythmPadBP and then the underlying heart rhythm and BP will be recorded. 12-lead ECG and BP reading will be obtained by standard devices for comparison.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients attending for routine 12-lead ECG, referred by the primary care physician and also&#xD;
        patients attending cardiology department at Ashford &amp; St Peters Hospitals NHS Foundation&#xD;
        Trust, Chertsey&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age greater or equal to 18 years&#xD;
&#xD;
          2. Able to consent&#xD;
&#xD;
          3. No known allergies to the metal or any component used in the RhythmPadBP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age less than 18 years&#xD;
&#xD;
          2. Not able to consent&#xD;
&#xD;
          3. Allergies to the metal or any component of the RhythmPadBP device&#xD;
&#xD;
          4. Active skin conditions affecting the hands, i.e. burns, infections&#xD;
&#xD;
          5. In-situ cardiac devices i.e. pacemaker or a defibrillator that could interfere with&#xD;
             the ECG recording.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Riyaz A Kaba, MBBS, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ashford and St Peter's Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ashford and St Peters NHS Trust</name>
      <address>
        <city>Chertsey</city>
        <state>Surrey</state>
        <zip>KT16 0PZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2019</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>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03813446
org study id: 2016RAK01
nct id: NCT03813446
lead sponsor: 
has dmc: No
This study will assess a new device, the RhythmPadBP, which detects heart rhythm and measure
      blood pressure simply by placing palms of the hands on a pad containing titanium electrodes.
Normally the way a doctor will assess the rhythm of the heart involves asking for an
      electrocardiogram (ECG) which involves having to remove clothing, and sometimes shaving hair.
      10 different leads are attached to stickers that are placed on the chest, and other parts of
      the body. This is known as a 12-lead ECG and is the standard way that heart-rhythm problems
      are first investigated. The usual method of measuring blood pressure (BP) involves wrapping a
      cuff around the arm and inflating it to enough to measure the BP. The reading is then
      displayed on a monitor. This can sometimes be uncomfortable and is often time consuming,
      particularly in busy clinical settings.

      Recent advances in technology however have given us different ways of gaining some of the
      same information given by a 12 lead ECG and the standard BP apparatus, using much easier to
      use devices. One of these devices is the RhythmPadBP system by Cardiocity TM. This is a
      device where participants can record the underlying heart rhythm and BP readings simply by
      placing palms of both hands on the device. This device does not require removal of clothing
      or placing a BP cuff around arm and so the readings can be gained more rapidly and with
      greater convenience.

      Investigators propose to test this device to assess how accurately it recognises the most
      common cardiac rhythm disturbances, e.g. atrial fibrillation (AF), and also measures the
      blood pressure. This will help to identify AF and any difference of BP in both arms.

      AF is an independent risk factor for stroke and increases the risk of stroke by five-fold. A
      discrepancy of BP in both arms can be a sign of blood vessel disease and is linked to
      increased risk of cardiovascular and cerebrovascular disease. If investigators find that this
      device is correctly recording AF and BP, it may give us another simpler way of diagnosing AF
      and BP discrepancies on both sides.
observational model: Cohort
time perspective: Prospective
measure: Diagnosis of Atrial Fibrillation
time frame: 18 months
description: The diagnosis of Atrial Fibrillation will be achieved through Cardiologist review of p-waves and QRS complexes on both a 1 lead and a 12 lead ECG conducted at the time of study for each participant.
measure: Measurement of BP in both arms with standard BP apparatus Vs RhythmPad BP recordings
time frame: 18 months
description: Measurement of blood pressure simultaneously from both arms comparing the two procedures. Both systolic and diastolic blood pressure will be recorded.
intervention type: Device
intervention name: Device: RhythmPadBP
description: Detection of heart rhythm and measurement of blood pressure
Intervention:
Patients will start by wearing a consumer SmartWatch (Huwaei SmartWatch 2, which has a CE mark) and a 60 second reading of their wrist Photoplethysmyograph (PPG) will be recorded. This will enable us to compare the PPG from the wrist with the fingertip data collected from the RhythmPadBP.
The watch will be cleaned with alcohol wipe in the same manner that the RhythmPadBP is cleaned between subjects use.
Patients will be asked to place their palms of both hands on RhythmPadBP and then the underlying heart rhythm and BP will be recorded. 12-lead ECG and BP reading will be obtained by standard devices for comparison.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Riyaz A Kaba, MBBS, FRCP
role: Principal Investigator
affiliation: Ashford and St Peter's Hospitals NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: Undecided