<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/NCT03279484</url>
  </required_header>
  <id_info>
    <org_study_id>LCPL01</org_study_id>
    <nct_id>NCT03279484</nct_id>
  </id_info>
  <brief_title>Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector</brief_title>
  <acronym>NAVIGATOR</acronym>
  <official_title>Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 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 electrical performance of&#xD;
      Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped&amp;U-shaped: NAVIGO 4LV 2D, NAVIGO&#xD;
      4LV ARC) and Straight (NAVIGO 4LV PILOT), with IS4 connector&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The devices under investigation, NAVIGO 4LV models Pilot, 2D , and ARC are the new&#xD;
      quadripolar coronary venous leads with polyurethane lead body, intended to be used with&#xD;
      defibrillators with ventricular resynchronization therapy.&#xD;
&#xD;
      The new lead design with the presence of 4 electrodes that allows several combinations in&#xD;
      programming pacing vectors, is intended to benefit both the patients by improving response to&#xD;
      therapy, overcoming high pacing threshold and avoiding phrenic nerve stimulation, and the&#xD;
      investigators by reducing the number of re-interventions needed.&#xD;
&#xD;
      This clinical investigation is a pre-market release study intended to analyze safety and&#xD;
      electrical performance of NAVIGO 4LV leads pre-shaped (S-shaped &amp; U-shaped) and Straight&#xD;
      leads models. The primary endpoint data will be used to support the achievement of the CE&#xD;
      mark of NAVIGO 4LV leads.&#xD;
&#xD;
      The primary endpoints will be evaluated at 1 month post-implantation; secondary endpoints&#xD;
      will be evaluated up to 2 years post-implantation. The duration of patient inclusion will be&#xD;
      approximately 10 months for pre-shaped NAVIGO family (S-shaped &amp;U-shaped) and approximately&#xD;
      21 months for straight ones.&#xD;
&#xD;
      The post implant follows-up visits will take place at Hospital discharge, weeks 10, 6 months&#xD;
      and every 6 months until 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 24, 2017</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">December 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>NAVIGO 4LV LV leads are available as &quot;S shaped&quot;(NAVIGO 4LV 2D) , &quot;U shaped&quot; (NAVIGO 4LV ARC) and &quot;straight&quot;( NAVIGO 4LV Pilot) models. All the models are available in 78 cm and 88 cm long versions. All models are designed for multipolar pacing (4 electrodes) and all of them have a quadripolar IS4 connector (IS4_LLLL).&#xD;
The NAVIGO 4LV leads are steroid eluting to avoid adverse effects due to inflammation reaction of the myocardium after positioning of the lead, and therefore to limit the acute pacing threshold peak. The steroid collar design is the same as the one used in all other LIVANOVA leads</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LV lead Safety at 10 weeks</measure>
    <time_frame>10 weeks after implant</time_frame>
    <description>Freedom from LV lead-related complications, defined as any investigational device deficiency or any serious adverse device event (SADE) that resulted in patient death or required a re-intervention (not including re-programming) that occurred within 30 days after successful implant of the CRT-D system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>LV lead Performance at 10 weeks</measure>
    <time_frame>10 weeks after implant</time_frame>
    <description>Successful performance defined as LV pacing threshold at 10 weeks &lt; 2.5 V/0.5 ms observed on at least one pacing vector and absence of phrenic nerve stimulation at programmed pacing amplitude</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Electrical performance</measure>
    <time_frame>through study completion, an average of 6 month</time_frame>
    <description>LV pacing threshold amplitude (V) and LV pacing impedance (Ohm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients free from LV lead-related complications</measure>
    <time_frame>through study completion, an average of 6 month</time_frame>
    <description>Freedom from LV lead-related complications defined as any investigational device deficiency or any serious adverse device event (SADE) that resulted in patient death or required a re-intervention (not including re-programming)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LV lead-related SAEs</measure>
    <time_frame>through study completion, an average of 6 month</time_frame>
    <description>Serious Adverse Event LV related</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lead handing assessment of NAVIGO 4LV leads through a questionnaire</measure>
    <time_frame>Implant</time_frame>
    <description>A questionnaire on lead handling will track opinion from the investigator, comparing his assessment with this lead to device he is accustomed to implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NAVIGO 4LV lead implant success rate on enrolled population</measure>
    <time_frame>Enrollment</time_frame>
    <description>To report the NAVIGO 4LV lead implant success rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with at least 2 pacing vectors with pacing threshold &lt; 2.5 V at 0.5 ms and no phrenic nerve stimulation</measure>
    <time_frame>10 weeks</time_frame>
    <description>To report the number of patients with at least 2 pacing vectors with pacing threshold &lt; 2.5 V at 0.5 ms and no phrenic nerve stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with MP pacing activated</measure>
    <time_frame>through study completion, an average of 6 month</time_frame>
    <description>To report the number of patients with MP pacing activated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rationale to activate MP</measure>
    <time_frame>through study completion, an average of 6 month</time_frame>
    <description>To report the reason why physician decide to activate MP to the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with of at least one MP configuration with no phrenic nerve stimulation at programmed pacing amplitude</measure>
    <time_frame>through study completion, an average of 6 month</time_frame>
    <description>To report the number of patients with at least one MP configuration with no phrenic nerve stimulation at programmed pacing amplitude</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients at each final programmed pacing vector and changes</measure>
    <time_frame>through study completion, an average of 6 month</time_frame>
    <description>To report number of patients at each final programmed pacing vector and changes</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">317</enrollment>
  <condition>Arrythmia, Implatable Cardioverter Defibrillation, Lead</condition>
  <arm_group>
    <arm_group_label>NAVIGO 4LV implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will be attempted to implant or implanted with NAVIGO 4LV lead</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NAVIGO 4LV lead implant</intervention_name>
    <description>All patients will be attempted to implant or implanted with NAVIGO 4LV lead</description>
    <arm_group_label>NAVIGO 4LV implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient presenting a CRT-D indication as detailed in the ESC guidelines&#xD;
&#xD;
          -  Primary implant of a PLATINIUM 4LV CRTD or upgrade from an existing ICD connected to a&#xD;
             RV lead with a DF4 connector (DF4LLHH) to a PLATINIUM 4LV CRT-D&#xD;
&#xD;
          -  Signed and dated informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients for whom a maximum single dose of 300 µg dexamethasone sodium phosphate (DSP)&#xD;
             eluted from the NAVIGO 4LV lead maybe contraindicated&#xD;
&#xD;
          -  Venous anomalies precluding transvenous implant (contraindication of a Pacemaker or&#xD;
             ICD implant)&#xD;
&#xD;
          -  Active myocarditis, pocket and/or lead infection&#xD;
&#xD;
          -  Stroke/myocardiaI infarction one month prior to implant&#xD;
&#xD;
          -  Already included in another clinical study that could confound the results of this&#xD;
             study.&#xD;
&#xD;
          -  Inability to meet Follow-up visits at the implanting centre as defined in the&#xD;
             investigational plan.&#xD;
&#xD;
          -  Patient less than 18 years old or under guardianship&#xD;
&#xD;
          -  Known pregnancy, women in lactation period or in childbearing age without an adequate&#xD;
             contraceptive method (failure rate &lt; 1%)&#xD;
&#xD;
          -  Drug addiction or abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Gabriel Martinez Martinez</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital General Universitario Alicante Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Hopital Trousseau</name>
      <address>
        <city>Chambray-lès-Tours</city>
        <zip>37170</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Robert Boulin</name>
      <address>
        <city>Libourne</city>
        <zip>33505</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hôpital Nord - Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Hospitalier Jacques Cartier</name>
      <address>
        <city>Massy</city>
        <zip>91349</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Annecy Genevois</name>
      <address>
        <city>Metz-Tessy</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris St Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux</name>
      <address>
        <city>Pessac</city>
        <zip>33600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hopital Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Valence</name>
      <address>
        <city>Valence</city>
        <zip>26953</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Brabois</name>
      <address>
        <city>Vandoeuvre les Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Gefässzentrum Bad Bevensen</name>
      <address>
        <city>Bad Bevensen</city>
        <zip>29594</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum</name>
      <address>
        <city>Bad Oeynhausen</city>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deutsches Herzzentrum Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evangelisches Krankenhaus</name>
      <address>
        <city>Bielefeld</city>
        <zip>33617</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Coburg</name>
      <address>
        <city>Coburg</city>
        <zip>96450</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologie Darmstadt</name>
      <address>
        <city>Darmstadt</city>
        <zip>64287</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäts-Herzzentrum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albertinen-Krankenhau</name>
      <address>
        <city>Hamburg</city>
        <zip>22457</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein, Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum</name>
      <address>
        <city>Wurzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi</name>
      <address>
        <city>Ancona</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Universitario Di Pisa</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp. Univ. S. Maria della Misericordia</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISALA Klinieken</name>
      <address>
        <city>Zwolle</city>
        <zip>10500</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)</name>
      <address>
        <city>Carnaxide</city>
        <zip>2799</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário de Coimbra -Hospitais da Universidade de Coimbra</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar e Universitário de Coimbra - Hospital Geral</name>
      <address>
        <city>Coimbra</city>
        <zip>3041-801</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro H. Lisboa Norte - Hospital de Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHCL - Hospital Santa Marta</name>
      <address>
        <city>Lisbon</city>
        <zip>1169-024</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar do Porto CHP Hospital de Santo Antonio</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</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 Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Universitario Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 13, 2019</last_update_submitted>
  <last_update_submitted_qc>September 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>safety , electrical performance</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/NCT03279484
org study id: LCPL01
nct id: NCT03279484
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 electrical performance of
      Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped&U-shaped: NAVIGO 4LV 2D, NAVIGO
      4LV ARC) and Straight (NAVIGO 4LV PILOT), with IS4 connector
The devices under investigation, NAVIGO 4LV models Pilot, 2D , and ARC are the new
      quadripolar coronary venous leads with polyurethane lead body, intended to be used with
      defibrillators with ventricular resynchronization therapy.

      The new lead design with the presence of 4 electrodes that allows several combinations in
      programming pacing vectors, is intended to benefit both the patients by improving response to
      therapy, overcoming high pacing threshold and avoiding phrenic nerve stimulation, and the
      investigators by reducing the number of re-interventions needed.

      This clinical investigation is a pre-market release study intended to analyze safety and
      electrical performance of NAVIGO 4LV leads pre-shaped (S-shaped & U-shaped) and Straight
      leads models. The primary endpoint data will be used to support the achievement of the CE
      mark of NAVIGO 4LV leads.

      The primary endpoints will be evaluated at 1 month post-implantation; secondary endpoints
      will be evaluated up to 2 years post-implantation. The duration of patient inclusion will be
      approximately 10 months for pre-shaped NAVIGO family (S-shaped &U-shaped) and approximately
      21 months for straight ones.

      The post implant follows-up visits will take place at Hospital discharge, weeks 10, 6 months
      and every 6 months until 2 years.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: NAVIGO 4LV LV leads are available as "S shaped"(NAVIGO 4LV 2D) , "U shaped" (NAVIGO 4LV ARC) and "straight"( NAVIGO 4LV Pilot) models. All the models are available in 78 cm and 88 cm long versions. All models are designed for multipolar pacing (4 electrodes) and all of them have a quadripolar IS4 connector (IS4_LLLL).
The NAVIGO 4LV leads are steroid eluting to avoid adverse effects due to inflammation reaction of the myocardium after positioning of the lead, and therefore to limit the acute pacing threshold peak. The steroid collar design is the same as the one used in all other LIVANOVA leads
primary purpose: Treatment
masking: None (Open Label)
measure: LV lead Safety at 10 weeks
time frame: 10 weeks after implant
description: Freedom from LV lead-related complications, defined as any investigational device deficiency or any serious adverse device event (SADE) that resulted in patient death or required a re-intervention (not including re-programming) that occurred within 30 days after successful implant of the CRT-D system
measure: LV lead Performance at 10 weeks
time frame: 10 weeks after implant
description: Successful performance defined as LV pacing threshold at 10 weeks < 2.5 V/0.5 ms observed on at least one pacing vector and absence of phrenic nerve stimulation at programmed pacing amplitude
measure: Electrical performance
time frame: through study completion, an average of 6 month
description: LV pacing threshold amplitude (V) and LV pacing impedance (Ohm)
measure: Rate of patients free from LV lead-related complications
time frame: through study completion, an average of 6 month
description: Freedom from LV lead-related complications defined as any investigational device deficiency or any serious adverse device event (SADE) that resulted in patient death or required a re-intervention (not including re-programming)
measure: LV lead-related SAEs
time frame: through study completion, an average of 6 month
description: Serious Adverse Event LV related
measure: Lead handing assessment of NAVIGO 4LV leads through a questionnaire
time frame: Implant
description: A questionnaire on lead handling will track opinion from the investigator, comparing his assessment with this lead to device he is accustomed to implant
measure: NAVIGO 4LV lead implant success rate on enrolled population
time frame: Enrollment
description: To report the NAVIGO 4LV lead implant success rate
measure: Number of patients with at least 2 pacing vectors with pacing threshold < 2.5 V at 0.5 ms and no phrenic nerve stimulation
time frame: 10 weeks
description: To report the number of patients with at least 2 pacing vectors with pacing threshold < 2.5 V at 0.5 ms and no phrenic nerve stimulation
measure: Number of patients with MP pacing activated
time frame: through study completion, an average of 6 month
description: To report the number of patients with MP pacing activated
measure: Rationale to activate MP
time frame: through study completion, an average of 6 month
description: To report the reason why physician decide to activate MP to the patient
measure: Number of patients with of at least one MP configuration with no phrenic nerve stimulation at programmed pacing amplitude
time frame: through study completion, an average of 6 month
description: To report the number of patients with at least one MP configuration with no phrenic nerve stimulation at programmed pacing amplitude
measure: Number of patients at each final programmed pacing vector and changes
time frame: through study completion, an average of 6 month
description: To report number of patients at each final programmed pacing vector and changes
arm group label: NAVIGO 4LV implant
arm group type: Experimental
description: All patients will be attempted to implant or implanted with NAVIGO 4LV lead
intervention type: Device
intervention name: NAVIGO 4LV lead implant
description: All patients will be attempted to implant or implanted with NAVIGO 4LV lead
arm group label: NAVIGO 4LV implant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Juan Gabriel Martinez Martinez
role: Principal Investigator
affiliation: Hospital General Universitario Alicante Spain
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country: France
country: Germany
country: Italy
country: Netherlands
country: Portugal
country: Spain
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac