<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/NCT02249195</url>
  </required_header>
  <id_info>
    <org_study_id>REVEAL</org_study_id>
    <nct_id>NCT02249195</nct_id>
  </id_info>
  <brief_title>Sub-project: Use of Small Implantable ECG Recorder in Pregnant Women With Arrhythmia</brief_title>
  <acronym>REVEAL</acronym>
  <official_title>Sub-project: Use of Small Implantable ECG Recorder in Pregnant Women With Arrhythmia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cape Town</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study will recruit pregnant or postpartum women presenting to Groote Schuur Hospital with&#xD;
      cardiovascular disease in 20 consecutive patients and will insert an implantable ECG&#xD;
      monitoring device. The patient will then be followed up over a duration of two year and will&#xD;
      be monitored for arrhythmia and mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      Worldwide, the numbers of women who have a pre-existing cardiovascular disease or develop&#xD;
      cardiac problems during pregnancy are increasing and, due to the lack of evidenced-based&#xD;
      data, this provides challenges for the treating physician. Cardiovascular disease in&#xD;
      pregnancy is a complex topic as women can present either pre- or postpartum, due to a&#xD;
      pre-existing heart disease such as e.g. operated or unoperated congenital heart disease,&#xD;
      valvular heart disease, and chronic hypertension or familial dilated cardiomyopathy. On the&#xD;
      other hand, there are diseases which are directly associated with pregnancy such as&#xD;
      hypertensive disorders of pregnancy and peripartum cardiomyopathy (PPCM). Women often present&#xD;
      with symptoms and signs of cardiovascular disease such as palpitations and shortness of&#xD;
      breath, or even directly in acute heart failure. There is, in particular, a paucity of data&#xD;
      from developing countries of this unique disease pattern and presentations. Pregnancy poses a&#xD;
      physiological stress test as cardiac output increases by 30-50% close to term. Further&#xD;
      haemodynamic stress occurs during labour and many of the effects of pregnancy on&#xD;
      cardiovascular disease (CVD) persist for several months after delivery.&#xD;
&#xD;
      Awareness of the different cardiovascular diseases that can occur in pregnancy or postpartum&#xD;
      has received limited attention and the main focus has been on hypertension and preeclampsia.&#xD;
      The global impact of elevated blood pressure (BP)/hypertension, in general, is profound, as&#xD;
      it is responsible for more deaths worldwide than any other cardiovascular risk factor,&#xD;
      including tobacco use, obesity and lipid disorders (Vos, Sliwa et al. Lancet 2012; Gersh &amp;&#xD;
      Sliwa, Eur Heart J 2010).&#xD;
&#xD;
      Beyond the higher income countries, 80% of worldwide CVD-related deaths now occur in low- and&#xD;
      middle-income countries (LMICs) (Sliwa, Stewart Circulation 2011; Abergunde, Mathers et al,&#xD;
      Lancet, 2007). In LMICs, morbid and fatal CVD-related events typically occur at a younger age&#xD;
      and affect more women (commonly in pregnancy), thereby exerting a more profound impact on the&#xD;
      family unit and the workforce. The recently published Global Burden of Disease Study which&#xD;
      reports on Years Lived with Disabilities (YLDs) for 1160 sequelae of 289 diseases and&#xD;
      injuries does not report on the prevalence of CVD pre- and postpartum as an entity. However,&#xD;
      globally, it is estimated that CVD and, in particular, hypertensive disorders of pregnancy,&#xD;
      complicate 2-8% of pregnancies contributing, to a major extent, to maternal mortality&#xD;
      worldwide (Sliwa, Cardiovascular Research, in press 2014). Chronic hypertension is now&#xD;
      prevalent in 3% of women falling pregnant in the US (Seely and Ecker, N Engl J Med, 2011) and&#xD;
      will also influence the prevalence of acute coronary syndromes (ACS) in pregnancy.&#xD;
&#xD;
      The recent confidential inquiry into maternal death in South Africa reported that of the 4867&#xD;
      deaths reported over 2 years, 14% were due to hypertensive disorders, with another 8.8% due&#xD;
      to medical and surgical conditions (www.hst.org/za/saving-mothers-2008-2010. This makes&#xD;
      cardiac disease in pregnancy a key focus area, with the aim of reducing morbidity and&#xD;
      mortality, not only by the South African Department of Health but also by the World Health&#xD;
      Organization and World Heart Federation.&#xD;
&#xD;
      We have recently carried out a single-centre prospective study on women presenting with CVD&#xD;
      in pregnancy at Groote Schuur Hospital, University of Cape Town, South Africa (manuscript&#xD;
      submitted). This study investigates an appropriate referral algorithm and reports on disease&#xD;
      presentation (n=226) and outcome of those patients, with significant disease warranting&#xD;
      follow-up at a tertiary care (n=152). Of the 152 women that were asked to come back for&#xD;
      follow-up, the CDMC 122 (80.2%) presented prepartum. The most common diagnoses where&#xD;
      congenital heart disease, valvular heart disease, cardiomyopathy and other diagnoses such as&#xD;
      e.g. Wolf-Parkinson-White, atrial fibrillation, arrhythmogenic right ventricular&#xD;
      cardiomyopathy.&#xD;
&#xD;
      Management of these patients is complex as palpitations in pregnancy are common due to&#xD;
      increased sympathetic tone. It is important to distinguish palpitations secondary to benign&#xD;
      tachycardias, such as sinus tachycardia, from more important arrhythmias, such as&#xD;
      supraventricular or ventricular tachyarrythmias. Supraventricular arrhythmias are known to&#xD;
      increase in pregnancy, presumably because of an increase in sympathetic tone. Ventricular&#xD;
      arrhythmias secondary to some long QT syndrome subtypes are known to increase in the&#xD;
      peripartum period. On the other hand, undiagnosed complex arrhythmia can have serious&#xD;
      consequences for the mother and fetus, including stroke and death. Most CV drugs are&#xD;
      contraindicated in pregnancy or have a FDA class C and D classification - e.g. beta-blockers&#xD;
      (C &amp; D), soltalol (C) and amiodarone (D). The treating physician therefore needs to document&#xD;
      the exact nature of the arrhythmia-causing symptoms, such as palpitations, dizziness and&#xD;
      syncope, prior to making a decision on pharmacological or device management. As 24-hour&#xD;
      holters have a low diagnostic yield, the use of an ECG loop recorder ( REVEAL) could&#xD;
      potentially influence management.&#xD;
&#xD;
      Interestingly, we have used the REVEAL XT in 2 pregnant women with newly diagnosed&#xD;
      arrrythmogenic right ventricular cardiomyopathy and a strong family history of sudden cardiac&#xD;
      death. Sinus tachycardia was present and correlated with the symptoms of palpitations. As&#xD;
      only supraventricular tachycardia was detected, patients could be managed conservatively and&#xD;
      had good maternal and fetal outcome. On the other hand, 2 other women presenting with&#xD;
      palpitations and dizziness in pregnancy were subsequently diagnosed with cardiac sarcoidosis,&#xD;
      a serious condition associated with sudden cardiac death.&#xD;
&#xD;
        1. Objectives:&#xD;
&#xD;
           1.1. To investigate the use of a small ECG loop recorder (REVEAL devices) in pregnant&#xD;
           women, with or without structural heart disease, in whom supra/ventricular&#xD;
           tachyarrhythmias and bradyarrythmias are suspected.&#xD;
&#xD;
           2.1. To investigate if the REVEAL device will change management compared to a single 24&#xD;
           hour holter done at presentation.&#xD;
&#xD;
           Our research question is based on preliminary information, having used the REVEAL XT in&#xD;
           2 pregnant women with newly diagnosed arrhythmogenic right ventricular cardiomyopathy&#xD;
           and a strong family history of sudden cardiac death. As only supraventricular sinus&#xD;
           tachycardia was detected, patients could be managed conservatively and had good maternal&#xD;
           and fetal outcome. On the other hand, 2 other women presenting with palpitations and&#xD;
           dizziness in pregnancy were subsequently diagnosed with cardiac sarcoidosis, a serious&#xD;
           condition associated with sudden cardiac death. A REVEAL device should have been used to&#xD;
           guide the physician in management.&#xD;
&#xD;
        2. Patient population&#xD;
&#xD;
           The patients will be recruited via a single-centre, prospective study of women with&#xD;
           cardiovascular disease presenting pre- or postpartum, attending Groote Schuur Hospital.&#xD;
           Since 1 July 2010, these patients have been seen at a weekly clinic, jointly run by&#xD;
           cardiologists and obstetricians, under the leadership of Prof. Karen Sliwa and Prof John&#xD;
           Anthony. We see about 100 new patients presenting with cardiovascular disease in&#xD;
           pregnancy per annum. About 200 newly diagnosed pregnant women with documented or&#xD;
           suspected cardiovascular disease will be screened for the indication to insert a REVEAL&#xD;
           device. Those patients will be part of an ongoing registry entitled: Registry of newly&#xD;
           diagnosed cases with cardiac disease in maternity-Phase II ( CDM-2).&#xD;
&#xD;
           Device:&#xD;
&#xD;
           The REVEAL device has the size of a larger USB stick and can be inserted under local&#xD;
           anaesthetic under sterile conditions as e.g. a minor procedure room. It is inserted&#xD;
           under the skin and there are no wires connecting it e.g. to the cardiac chambers or any&#xD;
           vessels. The device can record the cardiac rhythm for the period to up to one year. The&#xD;
           REVEAL is routinely ised in South Africa for more than 10 years.&#xD;
&#xD;
        3. Study design and treatment groups&#xD;
&#xD;
           A single-centre, observational outcome study investigating peripartum women presenting&#xD;
           with symptoms and signs of arrhythmia.&#xD;
&#xD;
           We aim to recruit 20 consecutive women with an indication for the REVEAL, from a&#xD;
           population of about 200 pregnant women with documented or suspected cardiovascular&#xD;
           disease as part of the ongoing cardiovascular disease in pregnancy registry.&#xD;
&#xD;
           Human Ethics Committee approval has been obtained for the overall prospective outcome&#xD;
           study on cardiovascular disease in pregnancy (HEC REF: 173/2010)&#xD;
&#xD;
           Estimate study duration: 2 years Estimate study start date: June 2014 Estimate study end&#xD;
           date: May 2016&#xD;
&#xD;
        4. Endpoints&#xD;
&#xD;
           Our prospective study will answer the questions whether REVEAL devices:&#xD;
&#xD;
           4.1. Are acceptable as a diagnostic tool in pregnant women. This will be assessed by&#xD;
           documentation of a number of women presenting with an indication to have the REVEAL&#xD;
           inserted (based on standard criteria) and a number of women accepting to have the&#xD;
           device. We see about 100 new patients presenting with cardiovascular disease in&#xD;
           pregnancy per annum.&#xD;
&#xD;
           4.2. Detect arrhythmias in pregnancy and can guide the cardiologist and obstetrician in&#xD;
           appropriate management, ranging from assurance, to medical therapy, to device therapy or&#xD;
           termination of pregnancy.&#xD;
&#xD;
           4.3. Change the management of the condition compared to a single ECG performed at the&#xD;
           day of offering insertion of the REVEAL device.&#xD;
&#xD;
        5. Measurable outputs and Publication Plan&#xD;
&#xD;
      Presentation of data In the past decade I have been invited annually to present my research&#xD;
      in the form of invited lectures at the following meetings: Congress of the Heart Failure&#xD;
      Association of the ESC; European Cardiac Society of Cardiology, World Congress of Cardiology,&#xD;
      South African Heart Failure Society, Pan African Cardiac Society. The data obtained from the&#xD;
      study will be presented at those meetings.&#xD;
&#xD;
      Publication of Original Data The data will be published as part of the overall cardiac&#xD;
      disease in pregnancy registry and as a separate paper.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">May 2016</completion_date>
  <primary_completion_date type="Anticipated">May 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>arrhythmia</measure>
    <time_frame>Two years</time_frame>
    <description>abnormal cardiac rhythm on ECG</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Two years</time_frame>
    <description>All cause mortality</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Arrhythmias in Pregnancy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The patients will be recruited via a single-centre, prospective study of women with&#xD;
        cardiovascular disease presenting pre- or postpartum, attending Groote Schuur Hospital.&#xD;
        Since 1 July 2010, these patients have been seen at a weekly clinic, jointly run by&#xD;
        cardiologists and obstetricians, under the leadership of Prof. Karen Sliwa and Prof John&#xD;
        Anthony. We see about 100 new patients presenting with cardiovascular disease in pregnancy&#xD;
        per annum. About 200 newly diagnosed pregnant women with documented or suspected&#xD;
        cardiovascular disease will be screened for the indication to insert a REVEAL device. Those&#xD;
        patients will be part of an ongoing registry entitled: Registry of newly diagnosed cases&#xD;
        with cardiac disease in maternity-Phase II ( CDM-2).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant or postpartum women presenting to Groote Schuur Hospital with cardiovascular&#xD;
             disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Individuals with structural heart disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Sliwa-Hahnle, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cape Town</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karen Sliwa-Hahnle, PhD</last_name>
    <phone>0027216501735</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Olivia Briton</last_name>
    <phone>0027214066088</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Cape Town</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7925</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen Sliwa-Hahnle, PhD</last_name>
      <phone>0027216501735</phone>
    </contact>
    <contact_backup>
      <last_name>Olivia Briton</last_name>
      <phone>0027214066088</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 22, 2014</last_update_submitted>
  <last_update_submitted_qc>September 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cape Town</investigator_affiliation>
    <investigator_full_name>Prof. Karen Sliwa-Hahnle</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>ECG loop recorder, pregnant women, arrhythmias</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</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/NCT02249195
org study id: REVEAL
nct id: NCT02249195
lead sponsor: 
has dmc: Yes
Study will recruit pregnant or postpartum women presenting to Groote Schuur Hospital with
      cardiovascular disease in 20 consecutive patients and will insert an implantable ECG
      monitoring device. The patient will then be followed up over a duration of two year and will
      be monitored for arrhythmia and mortality.
Background

      Worldwide, the numbers of women who have a pre-existing cardiovascular disease or develop
      cardiac problems during pregnancy are increasing and, due to the lack of evidenced-based
      data, this provides challenges for the treating physician. Cardiovascular disease in
      pregnancy is a complex topic as women can present either pre- or postpartum, due to a
      pre-existing heart disease such as e.g. operated or unoperated congenital heart disease,
      valvular heart disease, and chronic hypertension or familial dilated cardiomyopathy. On the
      other hand, there are diseases which are directly associated with pregnancy such as
      hypertensive disorders of pregnancy and peripartum cardiomyopathy (PPCM). Women often present
      with symptoms and signs of cardiovascular disease such as palpitations and shortness of
      breath, or even directly in acute heart failure. There is, in particular, a paucity of data
      from developing countries of this unique disease pattern and presentations. Pregnancy poses a
      physiological stress test as cardiac output increases by 30-50% close to term. Further
      haemodynamic stress occurs during labour and many of the effects of pregnancy on
      cardiovascular disease (CVD) persist for several months after delivery.

      Awareness of the different cardiovascular diseases that can occur in pregnancy or postpartum
      has received limited attention and the main focus has been on hypertension and preeclampsia.
      The global impact of elevated blood pressure (BP)/hypertension, in general, is profound, as
      it is responsible for more deaths worldwide than any other cardiovascular risk factor,
      including tobacco use, obesity and lipid disorders (Vos, Sliwa et al. Lancet 2012; Gersh &
      Sliwa, Eur Heart J 2010).

      Beyond the higher income countries, 80% of worldwide CVD-related deaths now occur in low- and
      middle-income countries (LMICs) (Sliwa, Stewart Circulation 2011; Abergunde, Mathers et al,
      Lancet, 2007). In LMICs, morbid and fatal CVD-related events typically occur at a younger age
      and affect more women (commonly in pregnancy), thereby exerting a more profound impact on the
      family unit and the workforce. The recently published Global Burden of Disease Study which
      reports on Years Lived with Disabilities (YLDs) for 1160 sequelae of 289 diseases and
      injuries does not report on the prevalence of CVD pre- and postpartum as an entity. However,
      globally, it is estimated that CVD and, in particular, hypertensive disorders of pregnancy,
      complicate 2-8% of pregnancies contributing, to a major extent, to maternal mortality
      worldwide (Sliwa, Cardiovascular Research, in press 2014). Chronic hypertension is now
      prevalent in 3% of women falling pregnant in the US (Seely and Ecker, N Engl J Med, 2011) and
      will also influence the prevalence of acute coronary syndromes (ACS) in pregnancy.

      The recent confidential inquiry into maternal death in South Africa reported that of the 4867
      deaths reported over 2 years, 14% were due to hypertensive disorders, with another 8.8% due
      to medical and surgical conditions (www.hst.org/za/saving-mothers-2008-2010. This makes
      cardiac disease in pregnancy a key focus area, with the aim of reducing morbidity and
      mortality, not only by the South African Department of Health but also by the World Health
      Organization and World Heart Federation.

      We have recently carried out a single-centre prospective study on women presenting with CVD
      in pregnancy at Groote Schuur Hospital, University of Cape Town, South Africa (manuscript
      submitted). This study investigates an appropriate referral algorithm and reports on disease
      presentation (n=226) and outcome of those patients, with significant disease warranting
      follow-up at a tertiary care (n=152). Of the 152 women that were asked to come back for
      follow-up, the CDMC 122 (80.2%) presented prepartum. The most common diagnoses where
      congenital heart disease, valvular heart disease, cardiomyopathy and other diagnoses such as
      e.g. Wolf-Parkinson-White, atrial fibrillation, arrhythmogenic right ventricular
      cardiomyopathy.

      Management of these patients is complex as palpitations in pregnancy are common due to
      increased sympathetic tone. It is important to distinguish palpitations secondary to benign
      tachycardias, such as sinus tachycardia, from more important arrhythmias, such as
      supraventricular or ventricular tachyarrythmias. Supraventricular arrhythmias are known to
      increase in pregnancy, presumably because of an increase in sympathetic tone. Ventricular
      arrhythmias secondary to some long QT syndrome subtypes are known to increase in the
      peripartum period. On the other hand, undiagnosed complex arrhythmia can have serious
      consequences for the mother and fetus, including stroke and death. Most CV drugs are
      contraindicated in pregnancy or have a FDA class C and D classification - e.g. beta-blockers
      (C & D), soltalol (C) and amiodarone (D). The treating physician therefore needs to document
      the exact nature of the arrhythmia-causing symptoms, such as palpitations, dizziness and
      syncope, prior to making a decision on pharmacological or device management. As 24-hour
      holters have a low diagnostic yield, the use of an ECG loop recorder ( REVEAL) could
      potentially influence management.

      Interestingly, we have used the REVEAL XT in 2 pregnant women with newly diagnosed
      arrrythmogenic right ventricular cardiomyopathy and a strong family history of sudden cardiac
      death. Sinus tachycardia was present and correlated with the symptoms of palpitations. As
      only supraventricular tachycardia was detected, patients could be managed conservatively and
      had good maternal and fetal outcome. On the other hand, 2 other women presenting with
      palpitations and dizziness in pregnancy were subsequently diagnosed with cardiac sarcoidosis,
      a serious condition associated with sudden cardiac death.

        1. Objectives:

           1.1. To investigate the use of a small ECG loop recorder (REVEAL devices) in pregnant
           women, with or without structural heart disease, in whom supra/ventricular
           tachyarrhythmias and bradyarrythmias are suspected.

           2.1. To investigate if the REVEAL device will change management compared to a single 24
           hour holter done at presentation.

           Our research question is based on preliminary information, having used the REVEAL XT in
           2 pregnant women with newly diagnosed arrhythmogenic right ventricular cardiomyopathy
           and a strong family history of sudden cardiac death. As only supraventricular sinus
           tachycardia was detected, patients could be managed conservatively and had good maternal
           and fetal outcome. On the other hand, 2 other women presenting with palpitations and
           dizziness in pregnancy were subsequently diagnosed with cardiac sarcoidosis, a serious
           condition associated with sudden cardiac death. A REVEAL device should have been used to
           guide the physician in management.

        2. Patient population

           The patients will be recruited via a single-centre, prospective study of women with
           cardiovascular disease presenting pre- or postpartum, attending Groote Schuur Hospital.
           Since 1 July 2010, these patients have been seen at a weekly clinic, jointly run by
           cardiologists and obstetricians, under the leadership of Prof. Karen Sliwa and Prof John
           Anthony. We see about 100 new patients presenting with cardiovascular disease in
           pregnancy per annum. About 200 newly diagnosed pregnant women with documented or
           suspected cardiovascular disease will be screened for the indication to insert a REVEAL
           device. Those patients will be part of an ongoing registry entitled: Registry of newly
           diagnosed cases with cardiac disease in maternity-Phase II ( CDM-2).

           Device:

           The REVEAL device has the size of a larger USB stick and can be inserted under local
           anaesthetic under sterile conditions as e.g. a minor procedure room. It is inserted
           under the skin and there are no wires connecting it e.g. to the cardiac chambers or any
           vessels. The device can record the cardiac rhythm for the period to up to one year. The
           REVEAL is routinely ised in South Africa for more than 10 years.

        3. Study design and treatment groups

           A single-centre, observational outcome study investigating peripartum women presenting
           with symptoms and signs of arrhythmia.

           We aim to recruit 20 consecutive women with an indication for the REVEAL, from a
           population of about 200 pregnant women with documented or suspected cardiovascular
           disease as part of the ongoing cardiovascular disease in pregnancy registry.

           Human Ethics Committee approval has been obtained for the overall prospective outcome
           study on cardiovascular disease in pregnancy (HEC REF: 173/2010)

           Estimate study duration: 2 years Estimate study start date: June 2014 Estimate study end
           date: May 2016

        4. Endpoints

           Our prospective study will answer the questions whether REVEAL devices:

           4.1. Are acceptable as a diagnostic tool in pregnant women. This will be assessed by
           documentation of a number of women presenting with an indication to have the REVEAL
           inserted (based on standard criteria) and a number of women accepting to have the
           device. We see about 100 new patients presenting with cardiovascular disease in
           pregnancy per annum.

           4.2. Detect arrhythmias in pregnancy and can guide the cardiologist and obstetrician in
           appropriate management, ranging from assurance, to medical therapy, to device therapy or
           termination of pregnancy.

           4.3. Change the management of the condition compared to a single ECG performed at the
           day of offering insertion of the REVEAL device.

        5. Measurable outputs and Publication Plan

      Presentation of data In the past decade I have been invited annually to present my research
      in the form of invited lectures at the following meetings: Congress of the Heart Failure
      Association of the ESC; European Cardiac Society of Cardiology, World Congress of Cardiology,
      South African Heart Failure Society, Pan African Cardiac Society. The data obtained from the
      study will be presented at those meetings.

      Publication of Original Data The data will be published as part of the overall cardiac
      disease in pregnancy registry and as a separate paper.
time perspective: Prospective
measure: arrhythmia
time frame: Two years
description: abnormal cardiac rhythm on ECG
measure: Mortality
time frame: Two years
description: All cause mortality
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Karen Sliwa-Hahnle, PhD
role: Principal Investigator
affiliation: University of Cape Town
last name: Karen Sliwa-Hahnle, PhD
phone: 0027216501735
last name: Olivia Briton
phone: 0027214066088
facility: 
status: Recruiting
contact: 
contact backup: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: University of Cape Town
investigator full name: Prof. Karen Sliwa-Hahnle
investigator title: Professor
mesh term: Arrhythmias, Cardiac