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/NCT05966675</url>
    </required_header>
    <id_info>
      <org_study_id>2022/ABM/03/00049</org_study_id>
      <nct_id>NCT05966675</nct_id>
    </id_info>
    <brief_title>Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI</brief_title>
    <acronym>PACE-4-TAVI</acronym>
    <official_title>Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Silesia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medical Research Agency, Poland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Medical University of Silesia</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 study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy&#xD;
        - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the&#xD;
        development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival&#xD;
        in patients after Transcatheter Aortic Valve Implantation (TAVI).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A multicenter randomized controlled head-to-head trial was planned to compare the effects of&#xD;
        permanent pacemaker implantation (PPMI) using CSP (study intervention) with currently&#xD;
        standard therapy - RVP or BVP (control group). The study population will consist of patients&#xD;
        hospitalized after TAVI complicated with high-degree persistent atrioventricular (AV) block&#xD;
        or newly developed complex AV or intraventricular conduction disturbances, qualified for PPMI&#xD;
        within 30 days after surgery, following the 2021 European Society of Cardiology (ESC)&#xD;
        guidelines on cardiac pacing and cardiac resynchronization therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">June 2028</completion_date>
    <primary_completion_date type="Anticipated">May 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients will be randomized 1:1 to the intervention and control groups. In the control group, the type of ventricular pacing will depend on the left ventricular ejection fraction (LVEF): 1) RVP is planned in the group of patients with LVEF ≥40%, 2) BVP is planned in the group of patients with LVEF &lt;40%, following current ESC guidelines.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Patient will be blind to type of intervention. Due to a need of method-specific use of hardware and tailored programming of cardiac devices, medical staff is impossible to blind. The inability to blind affects also echocardiographists and anyone performing device interrogation as significant differences in number and localisation of pacing leads, their electrical parameters and pacemaker settings are inherently different in studied arms.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Heart Failure Hospitalization</measure>
      <time_frame>12 months</time_frame>
      <description>Hospitalization due to heart failure as a main reason</description>
    </primary_outcome>
    <primary_outcome>
      <measure>All-cause death</measure>
      <time_frame>12 months</time_frame>
      <description>Death from any cause</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in exercise capacity</measure>
      <time_frame>24 months</time_frame>
      <description>Improvement or deterioration in exercise capacity assessed as a change of ≥1 New York Heart Association (NYHA) functional class or a change in 6-Minute Walk Test (6MWT) distance by 55m or more</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Response to Cardiac Resynchronization Therapy (CRT)</measure>
      <time_frame>24 months</time_frame>
      <description>Meeting the echocardiographic criteria of response to CRT defined as a decrease in Left Ventricular End Systolic Volume by ≥15% or an increase in Left Ventricular Ejection Fraction by ≥5% from the baseline values</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pacing-Induced Cardiomyopathy (PICM)</measure>
      <time_frame>24 months</time_frame>
      <description>Pacing-related CHF meeting the echocardiographic criteria of PICM defined as a decrease in LVEF by &gt;=10% to the absolute value of &lt;50%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in global longitudinal strain (GLS)</measure>
      <time_frame>24 months</time_frame>
      <description>An increase in GLS value of 20 absolute percentage points from baseline or an increase above -16%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Atrial Fibrillation (AF) episodes</measure>
      <time_frame>24 months</time_frame>
      <description>Occurrence of the first episode of AF in a patient with no previous history of atrial fibrillation (AF).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Atrial High Rate Episodes (AHRE) in pacemaker recordings</measure>
      <time_frame>24 months</time_frame>
      <description>Occurrence or change of the burden of AHRE events in the records from the CIED.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP)</measure>
      <time_frame>24 months</time_frame>
      <description>pl/mL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Quality of Life</measure>
      <time_frame>24 months</time_frame>
      <description>Assessed with Short Form Health Survey (SF-36): 0 to 100; low QoL to high QoL - better outcome.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Atrioventricular Block, Second and Third Degree</condition>
    <arm_group>
      <arm_group_label>Conduction System Pacing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Pacing Method</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients who receive currently standard pacing method with exact type of ventricular pacing depending upon left ventricular ejection fraction (LVEF): right ventricular pacing in case of LVEF &gt;= 40% or biventricular pacing if LVEF is determined to be less than 40%, as per current ESC guidelines.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>conduction system pacing</intervention_name>
      <description>Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).</description>
      <arm_group_label>Conduction System Pacing</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>right ventricular or biventricular pacing</intervention_name>
      <description>Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.</description>
      <arm_group_label>Standard Pacing Method</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification&#xD;
               to pacemaker implantation&#xD;
  &#xD;
            2. Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC&#xD;
               guidelines&#xD;
  &#xD;
            3. Written informed consent&#xD;
  &#xD;
            4. Age of at least 18 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Permanent pacemaker implantation before TAVI procedure&#xD;
  &#xD;
            2. The occurrence of conduction disturbances more than 30 days after TAVI procedure&#xD;
  &#xD;
            3. No written informed consent&#xD;
  &#xD;
            4. Inability to obtain informed consent from participant&#xD;
  &#xD;
            5. Predicted inability to obtain cooperation from patient during observation period&#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>Krzysztof S. Gołba, MD PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Silesian Medical University in Katowice</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Krzysztof S. Gołba, MD PhD</last_name>
      <phone>+48 (32)359-88-93</phone>
      <email>krzysztof.golba@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tomasz Soral, MD</last_name>
      <email>tomasz.soral@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Medical University of Silesia in Katowice</name>
        <address>
          <city>Katowice</city>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Krzysztof S. Gołba, MD PhD</last_name>
        <email>k.golba@sum.edu.pl</email>
      </contact>
      <contact_backup>
        <last_name>Tomasz Soral, MD</last_name>
        <email>tomasz.soral@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Danuta Łoboda, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rafał Gardas, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jolanta Biernat, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Grzegorz Jarosiński, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tomasz Soral, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <reference>
      <citation>Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available. Erratum In: Eur Heart J. 2022 May 1;43(17):1651.</citation>
      <PMID>34455430</PMID>
    </reference>
    <reference>
      <citation>Shimony A, Eisenberg MJ, Filion KB, Amit G. Beneficial effects of right ventricular non-apical vs. apical pacing: a systematic review and meta-analysis of randomized-controlled trials. Europace. 2012 Jan;14(1):81-91. doi: 10.1093/europace/eur240. Epub 2011 Jul 27.</citation>
      <PMID>21798880</PMID>
    </reference>
    <reference>
      <citation>Daubert JC, Ritter P, Le Breton H, Gras D, Leclercq C, Lazarus A, Mugica J, Mabo P, Cazeau S. Permanent left ventricular pacing with transvenous leads inserted into the coronary veins. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 2):239-45. doi: 10.1111/j.1540-8159.1998.tb01096.x.</citation>
      <PMID>9474680</PMID>
    </reference>
    <reference>
      <citation>Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016 Jun;13(6):1362-6. doi: 10.1016/j.hrthm.2016.03.040. Epub 2016 Mar 22. No abstract available.</citation>
      <PMID>27016475</PMID>
    </reference>
    <reference>
      <citation>Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.</citation>
      <PMID>31233818</PMID>
    </reference>
    <reference>
      <citation>Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Vijayaraman P, Czarnecka D. Programmed His Bundle Pacing: A Novel Maneuver for the Diagnosis of His Bundle Capture. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e007052. doi: 10.1161/CIRCEP.118.007052.</citation>
      <PMID>30707037</PMID>
    </reference>
    <reference>
      <citation>Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Kusiak A, Sondej T, Bednarski A, Vijayaraman P, Czarnecka D. Programmed deep septal stimulation: A novel maneuver for the diagnosis of left bundle branch capture during permanent pacing. J Cardiovasc Electrophysiol. 2020 Feb;31(2):485-493. doi: 10.1111/jce.14352. Epub 2020 Jan 20.</citation>
      <PMID>31930753</PMID>
    </reference>
    <reference>
      <citation>Nazif TM, Dizon JM, Hahn RT, Xu K, Babaliaros V, Douglas PS, El-Chami MF, Herrmann HC, Mack M, Makkar RR, Miller DC, Pichard A, Tuzcu EM, Szeto WY, Webb JG, Moses JW, Smith CR, Williams MR, Leon MB, Kodali SK; PARTNER Publications Office. Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):60-9. doi: 10.1016/j.jcin.2014.07.022.</citation>
      <PMID>25616819</PMID>
    </reference>
    <reference>
      <citation>Xi Z, Liu T, Liang J, Zhou YJ, Liu W. Impact of postprocedural permanent pacemaker implantation on clinical outcomes after transcatheter aortic valve replacement: a systematic review and meta-analysis. J Thorac Dis. 2019 Dec;11(12):5130-5139. doi: 10.21037/jtd.2019.12.02.</citation>
      <PMID>32030230</PMID>
    </reference>
    <reference>
      <citation>Xu S, Zhang E, Qian Z, Sun J, Zou F, Wang Y, Hou X, Zou J. Mid- to Long-Term Clinical and Echocardiographic Effects of Post-procedural Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Front Cardiovasc Med. 2022 Jun 28;9:911234. doi: 10.3389/fcvm.2022.911234. eCollection 2022.</citation>
      <PMID>35837611</PMID>
    </reference>
    <reference>
      <citation>Fadahunsi OO, Olowoyeye A, Ukaigwe A, Li Z, Vora AN, Vemulapalli S, Elgin E, Donato A. Incidence, Predictors, and Outcomes of Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement: Analysis From the U.S. Society of Thoracic Surgeons/American College of Cardiology TVT Registry. JACC Cardiovasc Interv. 2016 Nov 14;9(21):2189-2199. doi: 10.1016/j.jcin.2016.07.026.</citation>
      <PMID>27832844</PMID>
    </reference>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pacemaker</keyword>
    <keyword>Transcatheter Aortic Valve Replacement</keyword>
    <keyword>Conduction System Pacing (CSP)</keyword>
    <keyword>Atrioventricular Block</keyword>
    <keyword>Congestive Heart Failure</keyword>
    <keyword>Bradycardia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ventricular Dysfunction</mesh_term>
      <mesh_term>Ventricular Dysfunction, Left</mesh_term>
      <mesh_term>Atrioventricular Block</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05966675
  org study id: 2022/ABM/03/00049
  nct id: NCT05966675
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy
        - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the
        development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival
        in patients after Transcatheter Aortic Valve Implantation (TAVI).
  A multicenter randomized controlled head-to-head trial was planned to compare the effects of
        permanent pacemaker implantation (PPMI) using CSP (study intervention) with currently
        standard therapy - RVP or BVP (control group). The study population will consist of patients
        hospitalized after TAVI complicated with high-degree persistent atrioventricular (AV) block
        or newly developed complex AV or intraventricular conduction disturbances, qualified for PPMI
        within 30 days after surgery, following the 2021 European Society of Cardiology (ESC)
        guidelines on cardiac pacing and cardiac resynchronization therapy.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be randomized 1:1 to the intervention and control groups. In the control group, the type of ventricular pacing will depend on the left ventricular ejection fraction (LVEF): 1) RVP is planned in the group of patients with LVEF ≥40%, 2) BVP is planned in the group of patients with LVEF <40%, following current ESC guidelines.
  primary purpose: Prevention
  masking: Single (Participant)
  masking description: Patient will be blind to type of intervention. Due to a need of method-specific use of hardware and tailored programming of cardiac devices, medical staff is impossible to blind. The inability to blind affects also echocardiographists and anyone performing device interrogation as significant differences in number and localisation of pacing leads, their electrical parameters and pacemaker settings are inherently different in studied arms.
  measure: Heart Failure Hospitalization
  time frame: 12 months
  description: Hospitalization due to heart failure as a main reason
  measure: All-cause death
  time frame: 12 months
  description: Death from any cause
  measure: Change in exercise capacity
  time frame: 24 months
  description: Improvement or deterioration in exercise capacity assessed as a change of ≥1 New York Heart Association (NYHA) functional class or a change in 6-Minute Walk Test (6MWT) distance by 55m or more
  measure: Response to Cardiac Resynchronization Therapy (CRT)
  time frame: 24 months
  description: Meeting the echocardiographic criteria of response to CRT defined as a decrease in Left Ventricular End Systolic Volume by ≥15% or an increase in Left Ventricular Ejection Fraction by ≥5% from the baseline values
  measure: Pacing-Induced Cardiomyopathy (PICM)
  time frame: 24 months
  description: Pacing-related CHF meeting the echocardiographic criteria of PICM defined as a decrease in LVEF by >=10% to the absolute value of <50%
  measure: Change in global longitudinal strain (GLS)
  time frame: 24 months
  description: An increase in GLS value of 20 absolute percentage points from baseline or an increase above -16%.
  measure: Atrial Fibrillation (AF) episodes
  time frame: 24 months
  description: Occurrence of the first episode of AF in a patient with no previous history of atrial fibrillation (AF).
  measure: Atrial High Rate Episodes (AHRE) in pacemaker recordings
  time frame: 24 months
  description: Occurrence or change of the burden of AHRE events in the records from the CIED.
  measure: Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP)
  time frame: 24 months
  description: pl/mL
  measure: Change in Quality of Life
  time frame: 24 months
  description: Assessed with Short Form Health Survey (SF-36): 0 to 100; low QoL to high QoL - better outcome.
  arm group label: Conduction System Pacing
  arm group type: Experimental
  description: Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.
  arm group label: Standard Pacing Method
  arm group type: Active Comparator
  description: Patients who receive currently standard pacing method with exact type of ventricular pacing depending upon left ventricular ejection fraction (LVEF): right ventricular pacing in case of LVEF >= 40% or biventricular pacing if LVEF is determined to be less than 40%, as per current ESC guidelines.
  intervention type: Device
  intervention name: conduction system pacing
  description: Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).
  arm group label: Conduction System Pacing
  intervention type: Device
  intervention name: right ventricular or biventricular pacing
  description: Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.
  arm group label: Standard Pacing Method
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Krzysztof S. Gołba, MD PhD
  role: Study Chair
  affiliation: Silesian Medical University in Katowice
  last name: Krzysztof S. Gołba, MD PhD
  phone: +48 (32)359-88-93
  email: krzysztof.golba@gmail.com
  last name: Tomasz Soral, MD
  email: tomasz.soral@gmail.com
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Poland
  citation: Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available. Erratum In: Eur Heart J. 2022 May 1;43(17):1651.
  PMID: 34455430
  citation: Shimony A, Eisenberg MJ, Filion KB, Amit G. Beneficial effects of right ventricular non-apical vs. apical pacing: a systematic review and meta-analysis of randomized-controlled trials. Europace. 2012 Jan;14(1):81-91. doi: 10.1093/europace/eur240. Epub 2011 Jul 27.
  PMID: 21798880
  citation: Daubert JC, Ritter P, Le Breton H, Gras D, Leclercq C, Lazarus A, Mugica J, Mabo P, Cazeau S. Permanent left ventricular pacing with transvenous leads inserted into the coronary veins. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 2):239-45. doi: 10.1111/j.1540-8159.1998.tb01096.x.
  PMID: 9474680
  citation: Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016 Jun;13(6):1362-6. doi: 10.1016/j.hrthm.2016.03.040. Epub 2016 Mar 22. No abstract available.
  PMID: 27016475
  citation: Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.
  PMID: 31233818
  citation: Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Vijayaraman P, Czarnecka D. Programmed His Bundle Pacing: A Novel Maneuver for the Diagnosis of His Bundle Capture. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e007052. doi: 10.1161/CIRCEP.118.007052.
  PMID: 30707037
  citation: Jastrzebski M, Moskal P, Bednarek A, Kielbasa G, Kusiak A, Sondej T, Bednarski A, Vijayaraman P, Czarnecka D. Programmed deep septal stimulation: A novel maneuver for the diagnosis of left bundle branch capture during permanent pacing. J Cardiovasc Electrophysiol. 2020 Feb;31(2):485-493. doi: 10.1111/jce.14352. Epub 2020 Jan 20.
  PMID: 31930753
  citation: Nazif TM, Dizon JM, Hahn RT, Xu K, Babaliaros V, Douglas PS, El-Chami MF, Herrmann HC, Mack M, Makkar RR, Miller DC, Pichard A, Tuzcu EM, Szeto WY, Webb JG, Moses JW, Smith CR, Williams MR, Leon MB, Kodali SK; PARTNER Publications Office. Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):60-9. doi: 10.1016/j.jcin.2014.07.022.
  PMID: 25616819
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  PMID: 27832844
  responsible party type: Sponsor
  mesh term: Ventricular Dysfunction
  mesh term: Ventricular Dysfunction, Left
  mesh term: Atrioventricular Block
  sharing ipd: No