xml: <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/NCT06008340</url>
    </required_header>
    <id_info>
      <org_study_id>Pacing on Anxiety/ Depression</org_study_id>
      <nct_id>NCT06008340</nct_id>
    </id_info>
    <brief_title>Effect of Right Ventricle Lead Position on The Psychological Aspects of Patients With A Dual Chamber Pacemaker</brief_title>
    <official_title>Effect of Right Ventricle Lead Position on The Psychological Aspects of Patients With A Dual Chamber Pacemaker; A Prospective Comparative Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kafrelsheikh University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kafrelsheikh University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the current study was to determine the factors associated with increased&#xD;
        levels of anxiety and depression both before and after pacemaker implantation and examine if&#xD;
        changes in these symptoms occur during the first postoperative year.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Both clinical and experimental studies declared that RV pacing and the position of RV lead&#xD;
        may lead to ventricular desynchrony, mimics that of LBBB with subsequent abnormal mechanical&#xD;
        and electrical activation of the ventricles . This results in changes in cardiac perfusion,&#xD;
        hemodynamics, metabolism and mechanical function .&#xD;
  &#xD;
        With time, RV pacing may also lead to LV remodeling and structural changes . Also, it has&#xD;
        been mentioned that the presence of mechanical desynchrony after long-term RV pacing&#xD;
        especially the apical one is linked with reduced LV systolic function and deterioration in&#xD;
        the functional capacity and psychological aspects of the patients also in some cases adverse&#xD;
        clinical outcomes such as heart failure, atrial fibrillation and death However, in daily&#xD;
        clinical practice, not all patients with RV apical pacing will have these adverse events.&#xD;
  &#xD;
        Patients' depression and anxiety before and after pacemaker implantation have been&#xD;
        understudied. National and international literature show only few studies about anxiety and&#xD;
        depression in patients who experience a pacemaker but more research has reported that these&#xD;
        two variables are heavily noticed in cardiovascular patients.&#xD;
  &#xD;
        In fact, they are so frequent in patients with coronary artery disease, heart failure, and in&#xD;
        patients who had an implanted defibrillator. It has been suggested that anxiety and&#xD;
        depression have a prevalence ranging from 18% to 50% in cardiac patients . The few studies&#xD;
        that have studied anxiety and depression in pacemaker patients researched these variables&#xD;
        only in an unfaithful time from the implantation and without considering any changes before&#xD;
        and after the pacemaker implantation.&#xD;
  &#xD;
        In elderly population on the consequent increase of patients with pacemakers, this problem&#xD;
        becomes an essential one to study to support healthcare providers to know not only the&#xD;
        problem, but also who is at high risk to develop anxiety and depression. Research has&#xD;
        illustrated that lower levels of anxiety and depression among elderly patients are linked&#xD;
        with perceptions of higher quality of life and less need for the use of health services. The&#xD;
        improvement of wellbeing in elderly patients has implications for health care providers&#xD;
        designing preoperative and follow up care for patients undergoing pacemaker Implantation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Lead position and anxiety/ depression</measure>
      <time_frame>one year</time_frame>
      <description>Assessment of the effect of the pacemaker lead position in the right ventricle on the psychological aspects of the patients in 1 year follow up period.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Co morbidities and anxiety / depression</measure>
      <time_frame>one year</time_frame>
      <description>Assessment the correlation between hypertension, diabetes , ischemia and variable pacemaker complications on the anxiety and depression of the patients in 1 year follow up period</description>
    </secondary_outcome>
    <enrollment type="Actual">182</enrollment>
    <condition>Pacing-Induced Cardiomyopathy</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Dual chamber Pacemaker</intervention_name>
      <description>Anti bradycardia device implanted in patients with complete heart block, the device has 2 leads, one in the RT atrium and the other in RV. The RV lead positioned either apical or septal</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients suffering from heart block and indicated for permanent cardiac pacemaker&#xD;
          implantation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  implantation of a dual-chamber pacemaker,&#xD;
  &#xD;
            -  the ability to write and read the Arabic language,&#xD;
  &#xD;
            -  adequate follow-up and&#xD;
  &#xD;
            -  patients older than 18 years who were hospitalized for the first time for the&#xD;
               implantation procedure&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with history of psychiatric illness (mental, emotional, or behavioral&#xD;
               disorders),&#xD;
  &#xD;
            -  with a serious chronic disease,&#xD;
  &#xD;
            -  with implantable cardioverter defibrillator or biventricular pacemaker and&#xD;
  &#xD;
            -  patients who had not a stable programming of their device from the implantation.&#xD;
  &#xD;
            -  patients less than 18 years old,&#xD;
  &#xD;
            -  family and social environment problems prior and subsequent to PM implant,&#xD;
  &#xD;
            -  financial problems&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Reda Baiomy, PHD</last_name>
      <role>Study Director</role>
      <affiliation>Kafrelsheikh University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kafrelsheikh university</name>
        <address>
          <city>Kafr Ash Shaykh</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Prinzen FW, Peschar M. Relation between the pacing induced sequence of activation and left ventricular pump function in animals. Pacing Clin Electrophysiol. 2002 Apr;25(4 Pt 1):484-98. doi: 10.1046/j.1460-9592.2002.00484.x.</citation>
      <PMID>11991375</PMID>
    </reference>
    <reference>
      <citation>Tops LF, Schalij MJ, Holman ER, van Erven L, van der Wall EE, Bax JJ. Right ventricular pacing can induce ventricular dyssynchrony in patients with atrial fibrillation after atrioventricular node ablation. J Am Coll Cardiol. 2006 Oct 17;48(8):1642-8. doi: 10.1016/j.jacc.2006.05.072. Epub 2006 Sep 27.</citation>
      <PMID>17045901</PMID>
    </reference>
    <reference>
      <citation>Polikandrioti M, Tzirogiannis K, Zyga S, Koutelekos I, Vasilopoulos G, Theofilou P, Panoutsopoulos G. Effect of anxiety and depression on the fatigue of patients with a permanent pacemaker. Arch Med Sci Atheroscler Dis. 2018 Feb 5;3:e8-e17. doi: 10.5114/amsad.2018.73231. eCollection 2018.</citation>
      <PMID>30775584</PMID>
    </reference>
    <reference>
      <citation>Chesney MA, Rosenman RH. Type A behavior: Observations on the past decade. Heart Lung. 1982 Jan-Feb;11(1):12-9. No abstract available.</citation>
      <PMID>6915919</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kafrelsheikh University</investigator_affiliation>
      <investigator_full_name>Hassan El-Shirbiny</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>Anxiety</keyword>
    <keyword>Depression</keyword>
    <keyword>Psychological effect</keyword>
    <keyword>Dual chamber</keyword>
    <keyword>Pacemaker</keyword>
    <keyword>Pacing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiomyopathies</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008340
  org study id: Pacing on Anxiety/ Depression
  nct id: NCT06008340
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the current study was to determine the factors associated with increased
        levels of anxiety and depression both before and after pacemaker implantation and examine if
        changes in these symptoms occur during the first postoperative year.
  Both clinical and experimental studies declared that RV pacing and the position of RV lead
        may lead to ventricular desynchrony, mimics that of LBBB with subsequent abnormal mechanical
        and electrical activation of the ventricles . This results in changes in cardiac perfusion,
        hemodynamics, metabolism and mechanical function .
  
        With time, RV pacing may also lead to LV remodeling and structural changes . Also, it has
        been mentioned that the presence of mechanical desynchrony after long-term RV pacing
        especially the apical one is linked with reduced LV systolic function and deterioration in
        the functional capacity and psychological aspects of the patients also in some cases adverse
        clinical outcomes such as heart failure, atrial fibrillation and death However, in daily
        clinical practice, not all patients with RV apical pacing will have these adverse events.
  
        Patients' depression and anxiety before and after pacemaker implantation have been
        understudied. National and international literature show only few studies about anxiety and
        depression in patients who experience a pacemaker but more research has reported that these
        two variables are heavily noticed in cardiovascular patients.
  
        In fact, they are so frequent in patients with coronary artery disease, heart failure, and in
        patients who had an implanted defibrillator. It has been suggested that anxiety and
        depression have a prevalence ranging from 18% to 50% in cardiac patients . The few studies
        that have studied anxiety and depression in pacemaker patients researched these variables
        only in an unfaithful time from the implantation and without considering any changes before
        and after the pacemaker implantation.
  
        In elderly population on the consequent increase of patients with pacemakers, this problem
        becomes an essential one to study to support healthcare providers to know not only the
        problem, but also who is at high risk to develop anxiety and depression. Research has
        illustrated that lower levels of anxiety and depression among elderly patients are linked
        with perceptions of higher quality of life and less need for the use of health services. The
        improvement of wellbeing in elderly patients has implications for health care providers
        designing preoperative and follow up care for patients undergoing pacemaker Implantation.
  observational model: Case-Control
  time perspective: Prospective
  measure: Lead position and anxiety/ depression
  time frame: one year
  description: Assessment of the effect of the pacemaker lead position in the right ventricle on the psychological aspects of the patients in 1 year follow up period.
  measure: Co morbidities and anxiety / depression
  time frame: one year
  description: Assessment the correlation between hypertension, diabetes , ischemia and variable pacemaker complications on the anxiety and depression of the patients in 1 year follow up period
  intervention type: Device
  intervention name: Dual chamber Pacemaker
  description: Anti bradycardia device implanted in patients with complete heart block, the device has 2 leads, one in the RT atrium and the other in RV. The RV lead positioned either apical or septal
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Reda Baiomy, PHD
  role: Study Director
  affiliation: Kafrelsheikh University
  facility: 
  country: Egypt
  citation: Prinzen FW, Peschar M. Relation between the pacing induced sequence of activation and left ventricular pump function in animals. Pacing Clin Electrophysiol. 2002 Apr;25(4 Pt 1):484-98. doi: 10.1046/j.1460-9592.2002.00484.x.
  PMID: 11991375
  citation: Tops LF, Schalij MJ, Holman ER, van Erven L, van der Wall EE, Bax JJ. Right ventricular pacing can induce ventricular dyssynchrony in patients with atrial fibrillation after atrioventricular node ablation. J Am Coll Cardiol. 2006 Oct 17;48(8):1642-8. doi: 10.1016/j.jacc.2006.05.072. Epub 2006 Sep 27.
  PMID: 17045901
  citation: Polikandrioti M, Tzirogiannis K, Zyga S, Koutelekos I, Vasilopoulos G, Theofilou P, Panoutsopoulos G. Effect of anxiety and depression on the fatigue of patients with a permanent pacemaker. Arch Med Sci Atheroscler Dis. 2018 Feb 5;3:e8-e17. doi: 10.5114/amsad.2018.73231. eCollection 2018.
  PMID: 30775584
  citation: Chesney MA, Rosenman RH. Type A behavior: Observations on the past decade. Heart Lung. 1982 Jan-Feb;11(1):12-9. No abstract available.
  PMID: 6915919
  responsible party type: Principal Investigator
  investigator affiliation: Kafrelsheikh University
  investigator full name: Hassan El-Shirbiny
  investigator title: Principal investigator
  mesh term: Cardiomyopathies