<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/NCT03779165</url>
  </required_header>
  <id_info>
    <org_study_id>ZAPSA01</org_study_id>
    <secondary_id>UTN U1111-1223-2331</secondary_id>
    <nct_id>NCT03779165</nct_id>
  </id_info>
  <brief_title>R Wave Sensing After VT Ablation</brief_title>
  <acronym>RASA-VT</acronym>
  <official_title>R Wave Sensing After Radiofrequency Ablation of Ventricular Tachycardia Substrate in Patients With Structural Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital &quot;Sestre Milosrdnice&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital &quot;Sestre Milosrdnice&quot;</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>
      Sustained, monomorphic ventricular tachycardia (VT) is most commonly encountered in patients&#xD;
      with structural heart disease, usually with ischemic aetiology. It has been proven that&#xD;
      repeated episodes of sustained VT contribute to the mortality of patients with structural&#xD;
      heart disease. These patients are usually implanted with implantable cardioverter&#xD;
      defibrillator without (ICD) or with cardiac resynchronisation therapy (CRT-D). According to&#xD;
      the current guidelines 3D mapping with radiofrequency (RF) ablation of the tachycardia&#xD;
      substrate is an established therapeutic option. As part of the clinical follow-up of patients&#xD;
      implanted with cardiac implantable electronic devices (CIED), CIED function parameters are&#xD;
      monitored every 6 months, which is always done before and after any procedure involving RF&#xD;
      ablation. Furthermore, a transient drop of R wave sensing has been demonstrated after the&#xD;
      atrioventricular (AV) node ablation in patients with single-chamber pacemakers and fast&#xD;
      atrial fibrillation. The aim of this study is to assess the change in R wave sensing after&#xD;
      the RF ablation of VT substrate.&#xD;
&#xD;
      This study will be performed as a clinical, prospective, multi-centre, observational cohort&#xD;
      study with a structured follow-up period of 12 months. All consecutive patients with&#xD;
      sustained VT implanted with ICD or CRT-D undergoing RF ablation procedure of myocardial&#xD;
      substrate, who are able to understand and sign informed consent, will be enrolled. Primary&#xD;
      objective is a R wave sensing drop &gt; 30% after VT substrate ablation procedure. Recruiting&#xD;
      should not exceed 12 months with the minimal follow-up period of 12 months (24 months in&#xD;
      total). Standardized statistical methods and test will be done using SPSS Software Version&#xD;
      22.0 or newer.&#xD;
&#xD;
      This unique study offers the possibility to show the impact of RF ablation on short-term and&#xD;
      long-term R wave sensing change assessed by ICD or CRT-D's ventricle electrode in patients&#xD;
      with sustained VT and structural heart disease undergoing ablation procedure. This&#xD;
      observational data is needed to further refine the treatment of these patients and to prevent&#xD;
      possible ICD/CRT-D dysfunction which could endanger this patient population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sustained, monomorphic ventricular tachycardia (VT) is most commonly encountered in patients&#xD;
      with structural heart disease, usually with ischemic aetiology. It has been proven that&#xD;
      repeated episodes of sustained VT contribute to the mortality of patients with structural&#xD;
      heart disease. These patients are usually implanted with implantable cardioverter&#xD;
      defibrillator without (ICD) or with cardiac resynchronisation therapy (CRT-D) as part of&#xD;
      sudden cardiac death (SCD) prevention and have had activation of the device due to the&#xD;
      sustained VT episodes. According to the current guidelines 3D mapping with radiofrequency&#xD;
      (RF) ablation of the tachycardia substrate is an established therapeutic option. As part of&#xD;
      the clinical follow-up of patients implanted with cardiac implantable electronic devices&#xD;
      (CIED), including ICDs and CRT-Ds, function parameters are monitored every 6 months. The same&#xD;
      check-up is done before and after any procedure involving RF ablation. Furthermore, a&#xD;
      transient drop of R wave sensing has been demonstrated after the RF ablation of the&#xD;
      atrioventricular (AV) node in patients with uncontrollable fast atrial fibrillation implanted&#xD;
      with single-chamber pacemakers. The above mentioned have not been studied yet in patients&#xD;
      ablated due to sustained VT. Hence, the aim of this study is to assess the change in R wave&#xD;
      sensing after the RF ablation of VT substrate in patients with structural heart disease.&#xD;
&#xD;
      This study will be performed as a clinical, prospective, multi-centre, observational&#xD;
      (analytic, longitudinal) cohort study with patient enrolment in 4 electrophysiology centres&#xD;
      in Croatia and Switzerland and a structured follow-up period of 12 months.&#xD;
&#xD;
      All consecutive patients with sustained VT implanted with ICD or CRT-D undergoing RF ablation&#xD;
      procedure of myocardial substrate, who are able to understand and sign informed consent, will&#xD;
      be enrolled.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Patients with combined mechanical aortic and mitral valve prostheses&#xD;
&#xD;
        -  Patients with RF ablation of VT done in the last 12 months&#xD;
&#xD;
        -  Patients with known damaged ICD/CRT-D electrode or battery&#xD;
&#xD;
        -  Patients undergoing VT ablation who have not been implanted with ICD or CRT-D&#xD;
&#xD;
        -  Patients not willing or able to undergo clinical follow-up of ICD/CRT-D device&#xD;
&#xD;
        -  Patients with life expectancy &lt; 1 year&#xD;
&#xD;
        -  Not able to understand or willing to sign informed consent&#xD;
&#xD;
        -  Age &lt; 18 years Primary objective is a R wave sensing drop &gt; 30% after VT substrate&#xD;
           ablation procedure.&#xD;
&#xD;
      Specific (secondary) end-points:&#xD;
&#xD;
        -  incidence of VT recurrence after the ablation procedure;&#xD;
&#xD;
        -  risk factors for R wave sensing drop (&gt; 30%) after the RF ablation of VT substrate;&#xD;
&#xD;
        -  time needed for R wave sensing recovery after the RF ablation procedure. Recruiting&#xD;
           should not exceed 12 months with the minimal follow-up period of 12 months (24 months in&#xD;
           total).&#xD;
&#xD;
      The risk categorisation of the study was done and the study was awarded a risk category A.&#xD;
&#xD;
      Sample size was chosen according to annual procedure volumes in Croatia and Switzerland. In&#xD;
      addition, it is confirmed by power test (number needed to recruit: 52). Recruiting should not&#xD;
      exceed 12 months. Categorical variables will be presented by contingency tables in absolute&#xD;
      values and percentages. Categorical variables will be compared by the chi-square with Yates&#xD;
      corrections or Fisher's exact test. Continuous data will be expressed as means and standard&#xD;
      deviations or median with corresponding interquartile range. The differences in quantitative&#xD;
      variables will be tested by Mann-Whitney U-test (non-parametric test for independent&#xD;
      samples). Logistic regression will be used to analyse the association between all variables&#xD;
      of interest and the R wave sensing drop. Multivariate logistic regression will be used to&#xD;
      adjust for confounding factors. Predictors of the R wave sensing drop will be assessed in a&#xD;
      univariate and multivariate Cox proportional hazards model. The statistical analysis will be&#xD;
      done using SPSS Software Version 22.0 or newer (IBM SPSS Statistics, New York, USA).&#xD;
&#xD;
      This unique study offers the possibility to show the impact of RF ablation on short-term and&#xD;
      long-term R wave sensing change assessed by ICD or CRT-D's ventricle electrode in patients&#xD;
      with sustained VT and structural heart disease undergoing ablation procedure. This&#xD;
      observational data is needed to further refine the treatment of these patients and to prevent&#xD;
      possible ICD/CRT-D dysfunction which could endanger this patient population. Despite a high&#xD;
      number of cohort registries for cardiovascular diseases (e.g. Danish heart registry,&#xD;
      ORBIT-AF, GARFIELD AF registry, Swiss AF registry), there are scarce data on patients with&#xD;
      structural VT and no data regarding R wave sensing changes influenced by RF energy&#xD;
      application in ventricles. In addition, this could influence obligatory rhythm-monitoring&#xD;
      duration and consequently hospitalization duration of patients with VT undergoing RF ablation&#xD;
      procedures. Apart from the above mentioned, in those patients with non-optimal preprocedural&#xD;
      R wave sensing, this could mean contraindication for procedure or having the need to do&#xD;
      postprocedural defibrillation testing. It is likely, that data from our study will lead to&#xD;
      future changes in periprocedural planning and modalities.&#xD;
&#xD;
      This study will be conducted in compliance with the current version of the Declaration of&#xD;
      Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) as well as all national legal&#xD;
      and regulatory requirements. According to ethical regulations, the study plan with the&#xD;
      proposed participant information and consent form as well as other project-specific documents&#xD;
      will be submitted to Ethic committee of the participating centres.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>R wave sensing change</measure>
    <time_frame>immediately after the ablation procedure</time_frame>
    <description>R wave sensing drop &gt; 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>R wave sensing change 24h follow-up</measure>
    <time_frame>24 hours after ablation procedure</time_frame>
    <description>R wave sensing drop &gt; 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R wave sensing change 3-6 month follow-up</measure>
    <time_frame>3-6 months after ablation procedure</time_frame>
    <description>R wave sensing drop &gt; 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R wave sensing change 9-12 month follow-up</measure>
    <time_frame>9-12 months after the ablation procedure</time_frame>
    <description>R wave sensing drop &gt; 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of VT recurrence after the ablation procedure</measure>
    <time_frame>12 months after the ablation procedure</time_frame>
    <description>Assessing the VT recurrence after the ablation procedure by ICD or CRT-D interrogation adn function testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk factors for R wave sensing change after the RF ablation of VT substrate</measure>
    <time_frame>12 months</time_frame>
    <description>assessing risk factors for R wave sensing drop after the RF ablation of VT substrate</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Tachycardia, Ventricular</condition>
  <condition>Catheter Ablation</condition>
  <condition>Follow-Up Studies</condition>
  <condition>Electrodes</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with structural heart disease (ischemic and non-ischemic aetiology) implanted with&#xD;
        implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy&#xD;
        cardioverter defibrillator (CRT-D) and recurrent, sustained, monomorphic ventricular&#xD;
        tachycardia, who are, according to their cardiologist, planned for 3D mapping and&#xD;
        radiofrequency ablation of ventricular tachycardia myocardial substrate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with recurrent, sustained ventricular tachycardia&#xD;
&#xD;
          -  patients implanted with implantable cardioverter defibrillator (ICD) or cardiac&#xD;
             resynchronization therapy cardioverter defibrillator (CRT-D)&#xD;
&#xD;
          -  patients planned for 3D mapping and radiofrequency ablation of ventricular tachycardia&#xD;
             myocardial substrate&#xD;
&#xD;
          -  patients who are able to understand and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with combined mechanical aortic and mitral valve prostheses&#xD;
&#xD;
          -  Patients with RF ablation of VT done in the last 12 months&#xD;
&#xD;
          -  Patients with known damaged ICD/CRT-D electrode or battery&#xD;
&#xD;
          -  Patients undergoing VT ablation who have not been implanted with ICD or CRT-D&#xD;
&#xD;
          -  Patients not willing or able to undergo clinical follow-up of ICD/CRT-D device&#xD;
&#xD;
          -  Patients with life expectancy &lt; 1 year&#xD;
&#xD;
          -  Not able to understand or willing to sign informed consent&#xD;
&#xD;
          -  Age &lt; 18 years&#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>Ivan Zeljkovic, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital &quot;Sestre Milosrdnice&quot;</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ivan Zeljkovic, MD</last_name>
    <phone>0038513787733</phone>
    <email>ivanzeljkov@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nikola Pavlovic, MD</last_name>
    <phone>0038513787111</phone>
    <email>nikolap12@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Rijeka</name>
      <address>
        <city>Rijeka</city>
        <zip>51000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <contact>
      <last_name>Sandro Brusich, MD</last_name>
      <phone>0038551658111</phone>
      <email>sandro.brusich@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Sestre milosrdnice</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <contact>
      <last_name>Ivan Zeljkovic, MD</last_name>
      <phone>0038513787733</phone>
      <email>ivanzeljkov@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <contact>
      <last_name>Christian Sticherling, MD</last_name>
      <phone>+41 61 265 44 44</phone>
      <email>christian.sticherling@usb.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3012</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Darrat YH, Agarwal A, Morales GX, Thompson J, Abdel-Latif A, Waespe K, DI Biase L, Natale A, Patwardan A, Elayi CS. Radiofrequency and Cryo-Ablation Effect on Transvenous Pacing and Defibrillatory Lead Integrity: An In Vitro Study. J Cardiovasc Electrophysiol. 2016 Aug;27(8):976-80. doi: 10.1111/jce.13007. Epub 2016 Jun 14.</citation>
    <PMID>27138905</PMID>
  </results_reference>
  <results_reference>
    <citation>Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ; Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC)Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Europace. 2015 Nov;17(11):1601-87. doi: 10.1093/europace/euv319. Epub 2015 Aug 29. No abstract available.</citation>
    <PMID>26318695</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital &quot;Sestre Milosrdnice&quot;</investigator_affiliation>
    <investigator_full_name>Ivan Zeljkovic</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>ventricular tachycardia</keyword>
  <keyword>R wave; sensing</keyword>
  <keyword>radiofrequency ablation</keyword>
  <keyword>follow-up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</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/NCT03779165
org study id: ZAPSA01
secondary id: UTN U1111-1223-2331
nct id: NCT03779165
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sustained, monomorphic ventricular tachycardia (VT) is most commonly encountered in patients
      with structural heart disease, usually with ischemic aetiology. It has been proven that
      repeated episodes of sustained VT contribute to the mortality of patients with structural
      heart disease. These patients are usually implanted with implantable cardioverter
      defibrillator without (ICD) or with cardiac resynchronisation therapy (CRT-D). According to
      the current guidelines 3D mapping with radiofrequency (RF) ablation of the tachycardia
      substrate is an established therapeutic option. As part of the clinical follow-up of patients
      implanted with cardiac implantable electronic devices (CIED), CIED function parameters are
      monitored every 6 months, which is always done before and after any procedure involving RF
      ablation. Furthermore, a transient drop of R wave sensing has been demonstrated after the
      atrioventricular (AV) node ablation in patients with single-chamber pacemakers and fast
      atrial fibrillation. The aim of this study is to assess the change in R wave sensing after
      the RF ablation of VT substrate.

      This study will be performed as a clinical, prospective, multi-centre, observational cohort
      study with a structured follow-up period of 12 months. All consecutive patients with
      sustained VT implanted with ICD or CRT-D undergoing RF ablation procedure of myocardial
      substrate, who are able to understand and sign informed consent, will be enrolled. Primary
      objective is a R wave sensing drop > 30% after VT substrate ablation procedure. Recruiting
      should not exceed 12 months with the minimal follow-up period of 12 months (24 months in
      total). Standardized statistical methods and test will be done using SPSS Software Version
      22.0 or newer.

      This unique study offers the possibility to show the impact of RF ablation on short-term and
      long-term R wave sensing change assessed by ICD or CRT-D's ventricle electrode in patients
      with sustained VT and structural heart disease undergoing ablation procedure. This
      observational data is needed to further refine the treatment of these patients and to prevent
      possible ICD/CRT-D dysfunction which could endanger this patient population.
Sustained, monomorphic ventricular tachycardia (VT) is most commonly encountered in patients
      with structural heart disease, usually with ischemic aetiology. It has been proven that
      repeated episodes of sustained VT contribute to the mortality of patients with structural
      heart disease. These patients are usually implanted with implantable cardioverter
      defibrillator without (ICD) or with cardiac resynchronisation therapy (CRT-D) as part of
      sudden cardiac death (SCD) prevention and have had activation of the device due to the
      sustained VT episodes. According to the current guidelines 3D mapping with radiofrequency
      (RF) ablation of the tachycardia substrate is an established therapeutic option. As part of
      the clinical follow-up of patients implanted with cardiac implantable electronic devices
      (CIED), including ICDs and CRT-Ds, function parameters are monitored every 6 months. The same
      check-up is done before and after any procedure involving RF ablation. Furthermore, a
      transient drop of R wave sensing has been demonstrated after the RF ablation of the
      atrioventricular (AV) node in patients with uncontrollable fast atrial fibrillation implanted
      with single-chamber pacemakers. The above mentioned have not been studied yet in patients
      ablated due to sustained VT. Hence, the aim of this study is to assess the change in R wave
      sensing after the RF ablation of VT substrate in patients with structural heart disease.

      This study will be performed as a clinical, prospective, multi-centre, observational
      (analytic, longitudinal) cohort study with patient enrolment in 4 electrophysiology centres
      in Croatia and Switzerland and a structured follow-up period of 12 months.

      All consecutive patients with sustained VT implanted with ICD or CRT-D undergoing RF ablation
      procedure of myocardial substrate, who are able to understand and sign informed consent, will
      be enrolled.

      Exclusion criteria:

        -  Patients with combined mechanical aortic and mitral valve prostheses

        -  Patients with RF ablation of VT done in the last 12 months

        -  Patients with known damaged ICD/CRT-D electrode or battery

        -  Patients undergoing VT ablation who have not been implanted with ICD or CRT-D

        -  Patients not willing or able to undergo clinical follow-up of ICD/CRT-D device

        -  Patients with life expectancy < 1 year

        -  Not able to understand or willing to sign informed consent

        -  Age < 18 years Primary objective is a R wave sensing drop > 30% after VT substrate
           ablation procedure.

      Specific (secondary) end-points:

        -  incidence of VT recurrence after the ablation procedure;

        -  risk factors for R wave sensing drop (> 30%) after the RF ablation of VT substrate;

        -  time needed for R wave sensing recovery after the RF ablation procedure. Recruiting
           should not exceed 12 months with the minimal follow-up period of 12 months (24 months in
           total).

      The risk categorisation of the study was done and the study was awarded a risk category A.

      Sample size was chosen according to annual procedure volumes in Croatia and Switzerland. In
      addition, it is confirmed by power test (number needed to recruit: 52). Recruiting should not
      exceed 12 months. Categorical variables will be presented by contingency tables in absolute
      values and percentages. Categorical variables will be compared by the chi-square with Yates
      corrections or Fisher's exact test. Continuous data will be expressed as means and standard
      deviations or median with corresponding interquartile range. The differences in quantitative
      variables will be tested by Mann-Whitney U-test (non-parametric test for independent
      samples). Logistic regression will be used to analyse the association between all variables
      of interest and the R wave sensing drop. Multivariate logistic regression will be used to
      adjust for confounding factors. Predictors of the R wave sensing drop will be assessed in a
      univariate and multivariate Cox proportional hazards model. The statistical analysis will be
      done using SPSS Software Version 22.0 or newer (IBM SPSS Statistics, New York, USA).

      This unique study offers the possibility to show the impact of RF ablation on short-term and
      long-term R wave sensing change assessed by ICD or CRT-D's ventricle electrode in patients
      with sustained VT and structural heart disease undergoing ablation procedure. This
      observational data is needed to further refine the treatment of these patients and to prevent
      possible ICD/CRT-D dysfunction which could endanger this patient population. Despite a high
      number of cohort registries for cardiovascular diseases (e.g. Danish heart registry,
      ORBIT-AF, GARFIELD AF registry, Swiss AF registry), there are scarce data on patients with
      structural VT and no data regarding R wave sensing changes influenced by RF energy
      application in ventricles. In addition, this could influence obligatory rhythm-monitoring
      duration and consequently hospitalization duration of patients with VT undergoing RF ablation
      procedures. Apart from the above mentioned, in those patients with non-optimal preprocedural
      R wave sensing, this could mean contraindication for procedure or having the need to do
      postprocedural defibrillation testing. It is likely, that data from our study will lead to
      future changes in periprocedural planning and modalities.

      This study will be conducted in compliance with the current version of the Declaration of
      Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) as well as all national legal
      and regulatory requirements. According to ethical regulations, the study plan with the
      proposed participant information and consent form as well as other project-specific documents
      will be submitted to Ethic committee of the participating centres.
observational model: Cohort
time perspective: Prospective
measure: R wave sensing change
time frame: immediately after the ablation procedure
description: R wave sensing drop > 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED
measure: R wave sensing change 24h follow-up
time frame: 24 hours after ablation procedure
description: R wave sensing drop > 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED
measure: R wave sensing change 3-6 month follow-up
time frame: 3-6 months after ablation procedure
description: R wave sensing drop > 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED
measure: R wave sensing change 9-12 month follow-up
time frame: 9-12 months after the ablation procedure
description: R wave sensing drop > 30% after RF ablation of VT substrate in left and/or right ventricle assessed by ventricular electrode of the CIED
measure: Incidence of VT recurrence after the ablation procedure
time frame: 12 months after the ablation procedure
description: Assessing the VT recurrence after the ablation procedure by ICD or CRT-D interrogation adn function testing
measure: Risk factors for R wave sensing change after the RF ablation of VT substrate
time frame: 12 months
description: assessing risk factors for R wave sensing drop after the RF ablation of VT substrate
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ivan Zeljkovic, MD
role: Principal Investigator
affiliation: University Hospital "Sestre Milosrdnice"
last name: Ivan Zeljkovic, MD
phone: 0038513787733
email: ivanzeljkov@gmail.com
last name: Nikola Pavlovic, MD
phone: 0038513787111
email: nikolap12@yahoo.com
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
country: Croatia
country: Switzerland
citation: Darrat YH, Agarwal A, Morales GX, Thompson J, Abdel-Latif A, Waespe K, DI Biase L, Natale A, Patwardan A, Elayi CS. Radiofrequency and Cryo-Ablation Effect on Transvenous Pacing and Defibrillatory Lead Integrity: An In Vitro Study. J Cardiovasc Electrophysiol. 2016 Aug;27(8):976-80. doi: 10.1111/jce.13007. Epub 2016 Jun 14.
PMID: 27138905
citation: Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ; Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC)Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Europace. 2015 Nov;17(11):1601-87. doi: 10.1093/europace/euv319. Epub 2015 Aug 29. No abstract available.
PMID: 26318695
responsible party type: Principal Investigator
investigator affiliation: University Hospital "Sestre Milosrdnice"
investigator full name: Ivan Zeljkovic
investigator title: Principal Investigator
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
sharing ipd: No