<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/NCT01715116</url>
  </required_header>
  <id_info>
    <org_study_id>12/301</org_study_id>
    <nct_id>NCT01715116</nct_id>
  </id_info>
  <brief_title>ENHANCED Device Programming to Reduce Therapies and Improve Quality of Life in Implantable Cardioverter Defibrillator (ICD) Patients</brief_title>
  <acronym>ENHANCED-ICD</acronym>
  <official_title>ENHANCED Device Programming to Reduce Therapies and Improve Quality of Life in Implantable Cardioverter Defibrillator Patients: A Prospective, Single-arm Safety Monitoring Study (ENHANCED-ICD Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M. Meine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tilburg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Julius Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UMC Utrecht</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Enhanced device programming to reduce&#xD;
      therapies (i.e. anti tachycardia pacing (ATP) episodes and shocks (both appropriate and&#xD;
      inappropriate)) is safe for patients implanted with an Implantable Cardioverter-Defibrillator&#xD;
      (ICD). The secondary objective is to examine the impact of Enhanced programming on (i) ATPs&#xD;
      and shocks (both appropriate and inappropriate) and (ii) quality of life and distress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ICD therapy has become the first-line treatment for the prevention of sudden cardiac death&#xD;
      both as primary and secondary prevention due to its proven survival benefits as compared to&#xD;
      anti-arrhythmic drugs. However, ICD therapy is associated with a number of complications and&#xD;
      shocks that may impair patient quality of life and well being but also influence mortality.&#xD;
      Hence, reduction of ICD shocks by means of alternative programming of the device is paramount&#xD;
      for improving patient-centered outcomes and mortality.&#xD;
&#xD;
      The ENHANCED-ICD study will be a prospective, single-arm safety monitoring study. All&#xD;
      patients will receive Enhanced programming. Furthermore, patients will be asked to complete a&#xD;
      set of standardized and validated self-report questionnaires prior to ICD implantation, at&#xD;
      3-, 6-, and 12 months post implantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">April 2016</completion_date>
  <primary_completion_date type="Anticipated">April 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of intervention-related safety events</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Combined safety endpoint: arrhythmic syncope/hospitalization/death/other serious adverse event.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of ATPs/shocks</measure>
    <time_frame>2 months post implantation</time_frame>
    <description>ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ATPs/shocks</measure>
    <time_frame>6 months post implantation</time_frame>
    <description>ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ATPs/shocks</measure>
    <time_frame>12 months post implantation</time_frame>
    <description>ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Baseline</time_frame>
    <description>EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>3 months post implantation</time_frame>
    <description>EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 months post implantation</time_frame>
    <description>EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>12 months post implantation</time_frame>
    <description>EuroQol 5D (EQ-5D) and Short Form Health Survey 12 (SF-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress</measure>
    <time_frame>Baseline</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress</measure>
    <time_frame>3 months post implantation</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress</measure>
    <time_frame>6 months post implantation</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress</measure>
    <time_frame>12 months post implantation</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cardiac Arrhythmias</condition>
  <arm_group>
    <arm_group_label>Enhanced ICD programming</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Enhanced ICD programming</intervention_name>
    <description>VT monitor: &gt; 166/min&#xD;
fVT: &gt; 182/min; via VF 60/80 intervals (number of intervals to start ATP after approximately 20 s); 3 x ATP (8 stimuli, 88%, scan 20 ms); shock 1-5: 35 J; redetection 30/40 intervals.&#xD;
VF: &gt; 250/min; via VF 60/80 intervals (number of intervals to start therapy after approximately 15 s); 1 x ATP (8 stimuli, 88%) during charging; all shocks: 35 J; redetection 30/40 intervals&#xD;
SVT/VT discrimination is turned on, high rate time out is &quot;OFF&quot;&#xD;
SVT/VT discrimination single chamber: stability, wavelet; SVT upper rate limit: 222/min&#xD;
SVT/VT discrimination dual/triple chamber: P/R logic, wavelet; SVT upper rate limit: 222/min&#xD;
T wave-oversensing and lead noise discrimination is turned on in all devices.</description>
    <arm_group_label>Enhanced ICD programming</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a primary or secondary prophylactic indication for ICD therapy according to the&#xD;
             current European guidelines&#xD;
&#xD;
          -  implanted with a Medtronic ProtectaTM ICD/CRT-D device or any future CE-approved and&#xD;
             market-released Medtronic ICD/CRT-D devices with SmartShock technology&#xD;
&#xD;
          -  between 18-80 years of age&#xD;
&#xD;
          -  speaking and understanding Dutch&#xD;
&#xD;
          -  providing written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a life expectancy less than 1 year&#xD;
&#xD;
          -  a history of psychiatric illness other than affective/anxiety disorders&#xD;
&#xD;
          -  on the waiting list for heart transplantation&#xD;
&#xD;
          -  insufficient knowledge of the Dutch language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mathias Meine, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susanne Pedersen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tilburg University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mathias Meine, MD, PhD</last_name>
    <phone>+31(0)884666184</phone>
    <email>m.meine@umcutrecht.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Susanne S Pedersen, PhD</last_name>
    <phone>+ 31(0)134662067</phone>
    <email>s.s.pedersen@uvt.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Medical Center</name>
      <address>
        <city>Utrecht</city>
        <zip>3508 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Mathias Meine, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>April 16, 2013</last_update_submitted>
  <last_update_submitted_qc>April 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 17, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>UMC Utrecht</investigator_affiliation>
    <investigator_full_name>M. Meine</investigator_full_name>
    <investigator_title>Mathias Meine, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Cardiac arrhythmias</keyword>
  <keyword>Implantable Cardioverter-Defibrillator</keyword>
  <keyword>Patient Safety</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>November 6, 2017</submitted>
    <submission_canceled>June 6, 2018</submission_canceled>
    <submitted>June 6, 2018</submitted>
    <returned>December 20, 2018</returned>
    <submitted>September 30, 2021</submitted>
    <returned>October 28, 2021</returned>
  </pending_results>
  <!-- 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/NCT01715116
org study id: 12/301
nct id: NCT01715116
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether Enhanced device programming to reduce
      therapies (i.e. anti tachycardia pacing (ATP) episodes and shocks (both appropriate and
      inappropriate)) is safe for patients implanted with an Implantable Cardioverter-Defibrillator
      (ICD). The secondary objective is to examine the impact of Enhanced programming on (i) ATPs
      and shocks (both appropriate and inappropriate) and (ii) quality of life and distress.
ICD therapy has become the first-line treatment for the prevention of sudden cardiac death
      both as primary and secondary prevention due to its proven survival benefits as compared to
      anti-arrhythmic drugs. However, ICD therapy is associated with a number of complications and
      shocks that may impair patient quality of life and well being but also influence mortality.
      Hence, reduction of ICD shocks by means of alternative programming of the device is paramount
      for improving patient-centered outcomes and mortality.

      The ENHANCED-ICD study will be a prospective, single-arm safety monitoring study. All
      patients will receive Enhanced programming. Furthermore, patients will be asked to complete a
      set of standardized and validated self-report questionnaires prior to ICD implantation, at
      3-, 6-, and 12 months post implantation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of intervention-related safety events
time frame: up to 12 months
description: Combined safety endpoint: arrhythmic syncope/hospitalization/death/other serious adverse event.
measure: Number of ATPs/shocks
time frame: 2 months post implantation
description: ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.
measure: Number of ATPs/shocks
time frame: 6 months post implantation
description: ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.
measure: Number of ATPs/shocks
time frame: 12 months post implantation
description: ATPs/shocks shall be further classified based on: appropriate/inappropriate; successful/unsuccessful.
measure: Quality of life
time frame: Baseline
description: EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)
measure: Quality of life
time frame: 3 months post implantation
description: EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)
measure: Quality of life
time frame: 6 months post implantation
description: EuroQol 5D (EQ-5D)and Short Form Health Survey 12 (SF-12)
measure: Quality of life
time frame: 12 months post implantation
description: EuroQol 5D (EQ-5D) and Short Form Health Survey 12 (SF-12)
measure: Distress
time frame: Baseline
description: Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9)
measure: Distress
time frame: 3 months post implantation
description: Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)
measure: Distress
time frame: 6 months post implantation
description: Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)
measure: Distress
time frame: 12 months post implantation
description: Hospital Anxiety and Depression Scale (HADS)and Patient Health Questionnaire (PHQ-9)
arm group label: Enhanced ICD programming
arm group type: Experimental
intervention type: Device
intervention name: Enhanced ICD programming
description: VT monitor: > 166/min
fVT: > 182/min; via VF 60/80 intervals (number of intervals to start ATP after approximately 20 s); 3 x ATP (8 stimuli, 88%, scan 20 ms); shock 1-5: 35 J; redetection 30/40 intervals.
VF: > 250/min; via VF 60/80 intervals (number of intervals to start therapy after approximately 15 s); 1 x ATP (8 stimuli, 88%) during charging; all shocks: 35 J; redetection 30/40 intervals
SVT/VT discrimination is turned on, high rate time out is "OFF"
SVT/VT discrimination single chamber: stability, wavelet; SVT upper rate limit: 222/min
SVT/VT discrimination dual/triple chamber: P/R logic, wavelet; SVT upper rate limit: 222/min
T wave-oversensing and lead noise discrimination is turned on in all devices.
arm group label: Enhanced ICD programming
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mathias Meine, MD, PhD
role: Principal Investigator
affiliation: University Medical Center
last name: Susanne Pedersen, PhD
role: Principal Investigator
affiliation: Tilburg University
last name: Mathias Meine, MD, PhD
phone: +31(0)884666184
email: m.meine@umcutrecht.nl
last name: Susanne S Pedersen, PhD
phone: + 31(0)134662067
email: s.s.pedersen@uvt.nl
facility: 
status: Recruiting
investigator: 
country: Netherlands
responsible party type: Sponsor-Investigator
investigator affiliation: UMC Utrecht
investigator full name: M. Meine
investigator title: Mathias Meine, MD, PhD
mesh term: Arrhythmias, Cardiac
submitted: November 6, 2017
submission canceled: June 6, 2018
submitted: June 6, 2018
returned: December 20, 2018
submitted: September 30, 2021
returned: October 28, 2021