<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/NCT03259113</url>
  </required_header>
  <id_info>
    <org_study_id>20171331</org_study_id>
    <nct_id>NCT03259113</nct_id>
  </id_info>
  <brief_title>Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy</brief_title>
  <acronym>ElucidateHcm</acronym>
  <official_title>EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic CardioMyopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Gävleborg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norrlands University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Gävleborg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypertrophic cardiomyopathy (HCM) is associated with sudden cardiac death and an increased&#xD;
      risk of atrial fibrillation and subsequent embolic event. An insertable cardiac monitor will&#xD;
      provide data on cardiac rhythm over a period of 18 months. This will provide an extended&#xD;
      monitoring far longer than 24-48 hours of Holter monitoring as is currently usual care.&#xD;
      Therefore, detection of arrhythmias could be used in risk stratification and decision-making&#xD;
      with regard to offer an implantable defibrillator and anticoagulants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detection of non-sustained ventricular tachycardia (NSVT) and atrial fibrillation (AF) using&#xD;
      an insertable cardiac device monitor (SJM Confirm XT) which is connected to the patients&#xD;
      smart phone and monitored for 18 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Anticipated">April 16, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 16, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Consecutive insertable cardiac monitors in 30 patients with hypertrophic cardiomyopathy</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>NSVT</measure>
    <time_frame>18 months</time_frame>
    <description>Incidence of non-sustained ventricular tachycardia (NSVT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AF</measure>
    <time_frame>18 months</time_frame>
    <description>Incidence of atrial fibrillation (AF)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hypertrophic Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>Insertable cardiac monitor</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients will undergo monitoring using an insertable cardiac monitor (single arm)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insertable cardiac monitor</intervention_name>
    <description>Insertable cardiac monitor (SJM Confirm Rx) subcutaneously.</description>
    <arm_group_label>Insertable cardiac monitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hypertrophic cardiomyopathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  aortic stenosis (moderate, severe)&#xD;
&#xD;
          -  hypertrophic cardiomyopathy associated with metabolic disease (e.g. Fabry) and&#xD;
             syndromes (e.g. Noonan)&#xD;
&#xD;
          -  systolic heart failure&#xD;
&#xD;
          -  cardiac device (previous pacemaker, implantable defibrillator )&#xD;
&#xD;
          -  history of myocardial infarction&#xD;
&#xD;
          -  percutaneous coronary intervention and/or coronary artery by-pass grafting&#xD;
&#xD;
          -  pulmonary vein isolation, Maze surgery, ventricular tachycardia ablation, ectopic&#xD;
             atrial tachycardia ablation&#xD;
&#xD;
          -  renal clearance below 40&#xD;
&#xD;
          -  malignancy or other comorbidity with less than five years life expectancy&#xD;
&#xD;
          -  pregnancy of planned within 18 months&#xD;
&#xD;
          -  drug addiction, severe mental disease&#xD;
&#xD;
          -  not able to participate in 18 months follow-up&#xD;
&#xD;
          -  5 years risk more than 6% according HCM risk calculator of European Society of&#xD;
             Cardiology guidelines.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stellan Mörner, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norrlands Universitetssjukhus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Magnusson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Gävleborg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter Magnusson, MD</last_name>
    <phone>+46705089407</phone>
    <email>peter.magnusson@regiongavleborg.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stellan Mörner, MD PhD</last_name>
    <phone>+46730591068</phone>
    <email>stellan.morner@umu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Region Gavleborg</name>
      <address>
        <city>Gävle</city>
        <zip>80324</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Magnusson, M.D.</last_name>
      <phone>+46705089407</phone>
      <email>peter.magnusson@regiongavleborg.se</email>
    </contact>
    <contact_backup>
      <last_name>Stellan Mörner, M.D. Ph.D</last_name>
      <phone>+46730591068</phone>
      <email>stellan.morner@regiongavleborg.se</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Elliott PM, Gimeno JR, Thaman R, Shah J, Ward D, Dickie S, Tome Esteban MT, McKenna WJ. Historical trends in reported survival rates in patients with hypertrophic cardiomyopathy. Heart. 2006 Jun;92(6):785-91. doi: 10.1136/hrt.2005.068577. Epub 2005 Oct 10.</citation>
    <PMID>16216855</PMID>
  </reference>
  <reference>
    <citation>Maron BJ, Casey SA, Hauser RG, Aeppli DM. Clinical course of hypertrophic cardiomyopathy with survival to advanced age. J Am Coll Cardiol. 2003 Sep 3;42(5):882-8. doi: 10.1016/s0735-1097(03)00855-6.</citation>
    <PMID>12957437</PMID>
  </reference>
  <reference>
    <citation>Maron BJ, Olivotto I, Spirito P, Casey SA, Bellone P, Gohman TE, Graham KJ, Burton DA, Cecchi F. Epidemiology of hypertrophic cardiomyopathy-related death: revisited in a large non-referral-based patient population. Circulation. 2000 Aug 22;102(8):858-64. doi: 10.1161/01.cir.102.8.858.</citation>
    <PMID>10952953</PMID>
  </reference>
  <reference>
    <citation>Kofflard MJ, Ten Cate FJ, van der Lee C, van Domburg RT. Hypertrophic cardiomyopathy in a large community-based population: clinical outcome and identification of risk factors for sudden cardiac death and clinical deterioration. J Am Coll Cardiol. 2003 Mar 19;41(6):987-93. doi: 10.1016/s0735-1097(02)03004-8.</citation>
    <PMID>12651046</PMID>
  </reference>
  <reference>
    <citation>Elliott PM, Sharma S, Varnava A, Poloniecki J, Rowland E, McKenna WJ. Survival after cardiac arrest or sustained ventricular tachycardia in patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 1999 May;33(6):1596-601. doi: 10.1016/s0735-1097(99)00056-x.</citation>
    <PMID>10334430</PMID>
  </reference>
  <reference>
    <citation>American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Failure Society of America; Heart Rhythm Society; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; Gersh BJ, Maron BJ, Bonow RO, Dearani JA, Fifer MA, Link MS, Naidu SS, Nishimura RA, Ommen SR, Rakowski H, Seidman CE, Towbin JA, Udelson JE, Yancy CW. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2011 Dec;142(6):1303-38. doi: 10.1016/j.jtcvs.2011.10.019. No abstract available.</citation>
    <PMID>22093712</PMID>
  </reference>
  <reference>
    <citation>Authors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.</citation>
    <PMID>25173338</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Gävleborg</investigator_affiliation>
    <investigator_full_name>Peter Magnusson</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>insertable cardiac monitor</keyword>
  <keyword>atrial fibrillation</keyword>
  <keyword>non-sustained ventricular tachycardia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03259113
org study id: 20171331
nct id: NCT03259113
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypertrophic cardiomyopathy (HCM) is associated with sudden cardiac death and an increased
      risk of atrial fibrillation and subsequent embolic event. An insertable cardiac monitor will
      provide data on cardiac rhythm over a period of 18 months. This will provide an extended
      monitoring far longer than 24-48 hours of Holter monitoring as is currently usual care.
      Therefore, detection of arrhythmias could be used in risk stratification and decision-making
      with regard to offer an implantable defibrillator and anticoagulants.
Detection of non-sustained ventricular tachycardia (NSVT) and atrial fibrillation (AF) using
      an insertable cardiac device monitor (SJM Confirm XT) which is connected to the patients
      smart phone and monitored for 18 months.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Consecutive insertable cardiac monitors in 30 patients with hypertrophic cardiomyopathy
primary purpose: Diagnostic
masking: None (Open Label)
measure: NSVT
time frame: 18 months
description: Incidence of non-sustained ventricular tachycardia (NSVT)
measure: AF
time frame: 18 months
description: Incidence of atrial fibrillation (AF)
arm group label: Insertable cardiac monitor
arm group type: Other
description: All patients will undergo monitoring using an insertable cardiac monitor (single arm)
intervention type: Device
intervention name: Insertable cardiac monitor
description: Insertable cardiac monitor (SJM Confirm Rx) subcutaneously.
arm group label: Insertable cardiac monitor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Stellan Mörner, MD PhD
role: Principal Investigator
affiliation: Norrlands Universitetssjukhus
last name: Peter Magnusson, MD
role: Principal Investigator
affiliation: Region Gävleborg
last name: Peter Magnusson, MD
phone: +46705089407
email: peter.magnusson@regiongavleborg.se
last name: Stellan Mörner, MD PhD
phone: +46730591068
email: stellan.morner@umu.se
facility: 
status: Recruiting
contact: 
contact backup: 
country: Sweden
citation: Elliott PM, Gimeno JR, Thaman R, Shah J, Ward D, Dickie S, Tome Esteban MT, McKenna WJ. Historical trends in reported survival rates in patients with hypertrophic cardiomyopathy. Heart. 2006 Jun;92(6):785-91. doi: 10.1136/hrt.2005.068577. Epub 2005 Oct 10.
PMID: 16216855
citation: Maron BJ, Casey SA, Hauser RG, Aeppli DM. Clinical course of hypertrophic cardiomyopathy with survival to advanced age. J Am Coll Cardiol. 2003 Sep 3;42(5):882-8. doi: 10.1016/s0735-1097(03)00855-6.
PMID: 12957437
citation: Maron BJ, Olivotto I, Spirito P, Casey SA, Bellone P, Gohman TE, Graham KJ, Burton DA, Cecchi F. Epidemiology of hypertrophic cardiomyopathy-related death: revisited in a large non-referral-based patient population. Circulation. 2000 Aug 22;102(8):858-64. doi: 10.1161/01.cir.102.8.858.
PMID: 10952953
citation: Kofflard MJ, Ten Cate FJ, van der Lee C, van Domburg RT. Hypertrophic cardiomyopathy in a large community-based population: clinical outcome and identification of risk factors for sudden cardiac death and clinical deterioration. J Am Coll Cardiol. 2003 Mar 19;41(6):987-93. doi: 10.1016/s0735-1097(02)03004-8.
PMID: 12651046
citation: Elliott PM, Sharma S, Varnava A, Poloniecki J, Rowland E, McKenna WJ. Survival after cardiac arrest or sustained ventricular tachycardia in patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 1999 May;33(6):1596-601. doi: 10.1016/s0735-1097(99)00056-x.
PMID: 10334430
citation: American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Failure Society of America; Heart Rhythm Society; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; Gersh BJ, Maron BJ, Bonow RO, Dearani JA, Fifer MA, Link MS, Naidu SS, Nishimura RA, Ommen SR, Rakowski H, Seidman CE, Towbin JA, Udelson JE, Yancy CW. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2011 Dec;142(6):1303-38. doi: 10.1016/j.jtcvs.2011.10.019. No abstract available.
PMID: 22093712
citation: Authors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.
PMID: 25173338
responsible party type: Principal Investigator
investigator affiliation: Region Gävleborg
investigator full name: Peter Magnusson
investigator title: MD
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Hypertrophy
sharing ipd: No