<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/NCT03766919</url>
  </required_header>
  <id_info>
    <org_study_id>LNC001</org_study_id>
    <secondary_id>CIV-PT-18-08-025366</secondary_id>
    <nct_id>NCT03766919</nct_id>
  </id_info>
  <brief_title>Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector</brief_title>
  <acronym>FRIENDS</acronym>
  <official_title>Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MicroPort CRM</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MicroPort CRM</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>
      The primary objective of this study is to assess the safety and key electrical performance of&#xD;
      the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual&#xD;
      coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE fixation type models (single and dual coil:&#xD;
      INVICTA 1CT, INVICTA 2CT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FRIENDS study is a pre-market approval (INVICTA leads - devices under investigation - are not&#xD;
      CE marked), interventional, prospective, longitudinal, international (European), multicenter,&#xD;
      single arm study.&#xD;
&#xD;
      The devices under investigation, the INVICTA defibrillation leads, are new quadripolar leads,&#xD;
      to be used with Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy&#xD;
      Defibrillators (ICD/CRT-D).&#xD;
&#xD;
      This clinical study intends to demonstrate safety and electrical performances of the INVICTA&#xD;
      leads among the different models: active fixation either single coil (model 1CR) or dual coil&#xD;
      (model 2CR) and passive fixation, either single coil (model 1CT) or dual coil (model 2CT)&#xD;
      leads models. The clinical data will be used to support the application to CE marking of&#xD;
      INVICTA leads.&#xD;
&#xD;
      The primary endpoints will be evaluated at 3 months post-implantation; secondary endpoints&#xD;
      will be evaluated up to 2 years post-implantation.&#xD;
&#xD;
      A maximum number of 224 patients will be enrolled in the study, in up to 60 centers in&#xD;
      Europe.&#xD;
&#xD;
      The follow-up visits are scheduled at hospital discharge, at 1 month, at 3 months, at 6&#xD;
      months, at 12 months, at 18 months and at 24 months, post-implant .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 27, 2018</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2020</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>Freedom from INVICTA lead-related complications</measure>
    <time_frame>90 days</time_frame>
    <description>Freedom from INVICTA lead-related complications as assessed by an independent events adjudicator and defined as any INVICTA lead-related serious adverse device effect (SADE) that resulted in patient death or required an additional invasive intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>INVICTA lead electrical performance at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Right Ventricular (RV) pacing threshold (V) of the INVICTA lead, measured by the implanted ICD/CRT-D with 0.5 ms pulse width</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>INVICTA lead pacing threshold</measure>
    <time_frame>24 months</time_frame>
    <description>RV lead pacing threshold amplitude (V), measured by the implanted ICD/CRT-D with 0.5 ms pulse width</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>INVICTA lead impedances</measure>
    <time_frame>24 months</time_frame>
    <description>RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>INVICTA sensing threshold</measure>
    <time_frame>24 months</time_frame>
    <description>RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of the shocks that successfully terminate a ventricular arrhythmia episode</measure>
    <time_frame>24 months</time_frame>
    <description>Percentage of endocardial shock therapies that successfully terminate ventricular arrhythmia episodes, calculated as the proportion of successful shocks on the total number of shocks delivered during defibrillation testing or spontaneous ventricular arrhythmias.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>INVICTA lead complication free-rate up to 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Report of INVICTA lead complication free-rate (complication defined as any INVICTA lead-related serious adverse device effect (SADE) that resulted in patient death or required an additional invasive intervention) up to 24 months post-implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>INVICTA lead-related Serious Adverse Events and device deficiencies up to 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Report of INVICTA lead-related SADEs and device deficiencies occurred up to 24 months post-implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>INVICTA lead handling assessment</measure>
    <time_frame>At Implant (Day 0)</time_frame>
    <description>Summary of the investigators' opinion about INVICTA handling at implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>INVICTA lead implant success rate</measure>
    <time_frame>At Implant (Day 0)</time_frame>
    <description>% of enrolled patients successfully implanted with an INVICTA lead</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Ventricular Arrythmia</condition>
  <condition>Lead</condition>
  <condition>ICD</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>INVICTA lead</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implant of the INVICTA lead</intervention_name>
    <description>The implant or the attempt to implant an INVICTA lead</description>
    <arm_group_label>INVICTA lead</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Any patient presenting an ICD or CRT-D indication as detailed in the latest European&#xD;
             Society of Cardiology (ESC) guidelines&#xD;
&#xD;
          2. Scheduled for a primary implant of an ICD / CRT-D, manufactured by MicroPort CRM and&#xD;
             equipped with a RV DF4 connector&#xD;
&#xD;
          3. Signed and dated informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue)&#xD;
&#xD;
          2. Transient tachyarrhythmias due to reversible causes (such as drug intoxication,&#xD;
             electrolyte imbalance, sepsis, hypoxia or other factors as myocardial infarction or&#xD;
             electric shock)&#xD;
&#xD;
          3. Contraindication to a maximum single dose of 330 µg dexamethasone sodium phosphate&#xD;
             (DSP)&#xD;
&#xD;
          4. Active myocarditis&#xD;
&#xD;
          5. Already included in another clinical study that could confound the results of this&#xD;
             study&#xD;
&#xD;
          6. Inability to understand the purpose of the study or to meet follow-up visits at the&#xD;
             implanting centre as defined in the investigational plan&#xD;
&#xD;
          7. Patient less than 18 years old or under guardianship or kept in detention&#xD;
&#xD;
          8. Known pregnancy, women in breastfeeding or in childbearing age without an adequate&#xD;
             contraceptive method&#xD;
&#xD;
          9. Drug addiction or abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pedro MARQUES, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Santa Maria - Lisboa - Portugal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Valence</name>
      <address>
        <city>Valence</city>
        <zip>26000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniche Humanitas Gavazzeni</name>
      <address>
        <city>Bergamo</city>
        <zip>24125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Piemonte (IRCCS Bonino Pulejo)</name>
      <address>
        <city>Messina</city>
        <zip>98124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Lisboa Norte - Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <state>Hospitalet De Llobregat</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Alicante</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Girona Doctor Josepj Trueta</name>
      <address>
        <city>Girona</city>
        <zip>17190</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Victoria</name>
      <address>
        <city>Malaga</city>
        <zip>2901</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Italy</country>
    <country>Portugal</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>October 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>INVICTA</keyword>
  <keyword>Lead</keyword>
  <keyword>ICD</keyword>
  <keyword>CRT-D</keyword>
  <keyword>MicroPort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT03766919
org study id: LNC001
secondary id: CIV-PT-18-08-025366
nct id: NCT03766919
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to assess the safety and key electrical performance of
      the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual
      coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE fixation type models (single and dual coil:
      INVICTA 1CT, INVICTA 2CT).
FRIENDS study is a pre-market approval (INVICTA leads - devices under investigation - are not
      CE marked), interventional, prospective, longitudinal, international (European), multicenter,
      single arm study.

      The devices under investigation, the INVICTA defibrillation leads, are new quadripolar leads,
      to be used with Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy
      Defibrillators (ICD/CRT-D).

      This clinical study intends to demonstrate safety and electrical performances of the INVICTA
      leads among the different models: active fixation either single coil (model 1CR) or dual coil
      (model 2CR) and passive fixation, either single coil (model 1CT) or dual coil (model 2CT)
      leads models. The clinical data will be used to support the application to CE marking of
      INVICTA leads.

      The primary endpoints will be evaluated at 3 months post-implantation; secondary endpoints
      will be evaluated up to 2 years post-implantation.

      A maximum number of 224 patients will be enrolled in the study, in up to 60 centers in
      Europe.

      The follow-up visits are scheduled at hospital discharge, at 1 month, at 3 months, at 6
      months, at 12 months, at 18 months and at 24 months, post-implant .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from INVICTA lead-related complications
time frame: 90 days
description: Freedom from INVICTA lead-related complications as assessed by an independent events adjudicator and defined as any INVICTA lead-related serious adverse device effect (SADE) that resulted in patient death or required an additional invasive intervention.
measure: INVICTA lead electrical performance at 3 months
time frame: 3 months
description: Right Ventricular (RV) pacing threshold (V) of the INVICTA lead, measured by the implanted ICD/CRT-D with 0.5 ms pulse width
measure: INVICTA lead pacing threshold
time frame: 24 months
description: RV lead pacing threshold amplitude (V), measured by the implanted ICD/CRT-D with 0.5 ms pulse width
measure: INVICTA lead impedances
time frame: 24 months
description: RV lead pacing impedance (Ohm) and defibrillation coil impedance (Ohm), measured by the implanted ICD/CRT-D
measure: INVICTA sensing threshold
time frame: 24 months
description: RV lead endocardial R wave amplitude (mV), measured by the implanted ICD/CRT-D
measure: Percentage of the shocks that successfully terminate a ventricular arrhythmia episode
time frame: 24 months
description: Percentage of endocardial shock therapies that successfully terminate ventricular arrhythmia episodes, calculated as the proportion of successful shocks on the total number of shocks delivered during defibrillation testing or spontaneous ventricular arrhythmias.
measure: INVICTA lead complication free-rate up to 24 months
time frame: 24 months
description: Report of INVICTA lead complication free-rate (complication defined as any INVICTA lead-related serious adverse device effect (SADE) that resulted in patient death or required an additional invasive intervention) up to 24 months post-implantation
measure: INVICTA lead-related Serious Adverse Events and device deficiencies up to 24 months
time frame: 24 months
description: Report of INVICTA lead-related SADEs and device deficiencies occurred up to 24 months post-implantation
measure: INVICTA lead handling assessment
time frame: At Implant (Day 0)
description: Summary of the investigators' opinion about INVICTA handling at implant
measure: INVICTA lead implant success rate
time frame: At Implant (Day 0)
description: % of enrolled patients successfully implanted with an INVICTA lead
arm group label: INVICTA lead
arm group type: Experimental
description: All patients eligible for enrolment in whom the INVICTA lead is attempted (Implant of the INVICTA lead)
intervention type: Device
intervention name: Implant of the INVICTA lead
description: The implant or the attempt to implant an INVICTA lead
arm group label: INVICTA lead
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pedro MARQUES, MD
role: Principal Investigator
affiliation: Hospital de Santa Maria - Lisboa - Portugal
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Italy
country: Portugal
country: Spain
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No