<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/NCT04489095</url>
  </required_header>
  <id_info>
    <org_study_id>Frisoli_13944</org_study_id>
    <nct_id>NCT04489095</nct_id>
  </id_info>
  <brief_title>Conduction Disease After Transcatheter Aortic Valve Replacement</brief_title>
  <official_title>Evaluation of Conduction Disease After Trans-catheter Aortic Valve Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective single center Cardiology department observational study. The study aim&#xD;
      is to better understand the predictors of high grade conduction abnormalities associated with&#xD;
      TAVR such that a more robust evidence-based and universal strategy to manage cardiac&#xD;
      conduction disturbances in these patients, which has been elusive, can be developed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      TAVR is a very commonly performed procedure throughout the world; it has become standard of&#xD;
      care as the treatment for aortic stenosis and is performed in hundreds of thousands of&#xD;
      patients annually. TAVR affords patients therapies that prolong life and improve quality of&#xD;
      life; furthermore, these therapies afford certain patients who are not candidates for&#xD;
      surgical options hope for the future. Adults undergoing TAVR may suffer the complication of&#xD;
      requiring a pacemaker after the procedure, in up to 30% of cases. Interventionalists still&#xD;
      don't understand how to best predict this complication; in fact some patients that ultimately&#xD;
      need a pacemaker don't get one after the procedure and some that get a pacemaker are found to&#xD;
      ultimately not have really needed it. A better understanding of which patients do and do not&#xD;
      need pacemakers will help prevent complications of high grade block in those without&#xD;
      pacemaker (death, syncope and trauma) and also the complications of unnecessary pacemaker&#xD;
      implantation (infection, tricuspid regurgitation).&#xD;
&#xD;
      Primary hypothesis: EP studies (EPS), when performed before and after TAVR adds independent&#xD;
      incremental value, above and beyond other parameters, for the prediction of high-grade heart&#xD;
      block after TAVR. The goal is to understand conduction disease changes before and after TAVR,&#xD;
      coupled with other patient and procedural factors that can help create a management algorithm&#xD;
      for conduction disease after TAVR.&#xD;
&#xD;
      Primary endpoint: to find correlation coefficients between a) absolute and delta values of&#xD;
      various EPS findings, and b) clinical endpoint of high-grade conduction disease as diagnosed&#xD;
      clinically, by ECG, by event monitor, or by interrogation of permanent pacemaker implanted&#xD;
      after TAVR.&#xD;
&#xD;
      Methods: Patients will receive EPS immediately before and after TAVR (while on the&#xD;
      catheterization lab table for TAVR procedure) and then again the next day; this information&#xD;
      will help determine whether the patient gets a pacemaker, a 30-day event monitor, or neither.&#xD;
      The investigators will study which parameters obtained during the EPS, in addition to other&#xD;
      known/suspected predictors of conduction disease after TAVR, best correlate with serious&#xD;
      problems with the heart's electrical conduction system as determined by clinical follow-up.&#xD;
&#xD;
      Anticipated findings: that the EPS findings add incremental and independent value in&#xD;
      predicting which patients will develop high grade conduction disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Actual">August 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 17, 2022</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>After informed consent is obtained, patient will undergo TAVR as per usual standard of care. Using the same femoral vein access as is used standard for a portion of the TAVR procedure, an EPS(Electrophysiology study) will be performed during the TAVR procedure, immediately before and after valve implantation. The patient will recover on a general telemetry floor as per usual care, and the next day will undergo another EPS. This is not uncommonly done clinically for some patients after TAVR. At that point, based on the baseline EKG, intra-procedure findings, and EPS findings, the patient will either have a pacemaker implanted, a 30-day event monitor ordered, or neither of the above.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>High grade conduction disease post TAVR</measure>
    <time_frame>1 year</time_frame>
    <description>Number of participants that develop high grade conduction block post TAVR including complete heart block, 2nd degree AV block, symptomatic bradycardia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>death</measure>
    <time_frame>1 year</time_frame>
    <description>Rate of mortality by chart review and SSDI query at 1 year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rehospitalization</measure>
    <time_frame>1 year</time_frame>
    <description>Absolute and per patient hospitalizations post index procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>need for pacemaker implantation</measure>
    <time_frame>1 year</time_frame>
    <description>Percentage of participants requiring permanent pacemaker implantation in index hospitalization or within 1 year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HV interval pre and post TAVR</measure>
    <time_frame>2 days</time_frame>
    <description>Absolute HV interval in milliseconds as measure by electrophysiology study for each participant pre and post TAVR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ejection fraction</measure>
    <time_frame>1 year</time_frame>
    <description>Ejection fraction as measured by trans-thoracic echocardiography for each participant pre and post tavr on routine trans-thoracic echocardiography</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Aortic Stenosis</condition>
  <condition>Heart Block</condition>
  <condition>Aortic Insufficiency</condition>
  <arm_group>
    <arm_group_label>Electrophysiology Study pre and Post TAVR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In all patient's undergoing TAVR after informed consent will undergo an electrophysiology study pre and post device deployment in order to determine the need for permanent pacemaker implantation or further testing/monitoring.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Electrophysiology Study</intervention_name>
    <description>After informed consent is obtained, patient will undergo TAVR as per usual standard of care. Using the same femoral vein access as is used standard for a portion of the TAVR procedure, an EPS will be performed during the TAVR procedure, immediately before and after valve implantation. The patient will recover on a general telemetry floor as per usual care, and the next day will undergo another EPS. This is not uncommonly done clinically for some patients after TAVR. At that point, based on the baseline EKG, intra-procedure findings, and EPS findings, the patient will either have a pacemaker implanted, a 30-day event monitor ordered, or neither of the above.</description>
    <arm_group_label>Electrophysiology Study pre and Post TAVR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Signed and dated Informed Consent&#xD;
&#xD;
          -  Patient that undergoes a TAVR&#xD;
&#xD;
          -  Ability to complete functional assessments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pre-existing permanent pacemaker.&#xD;
&#xD;
          -  Patient unwilling or unable to follow-up for necessary pre- and post-procedure&#xD;
             clinical assessments.&#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>Tiberio Frisoli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Tiberio Frisoli</investigator_full_name>
    <investigator_title>MD Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Transcatheter Aortic Valve Replacement</keyword>
  <keyword>TAVR</keyword>
  <keyword>Aortic stenosis</keyword>
  <keyword>AS</keyword>
  <keyword>Pacemaker</keyword>
  <keyword>HV interval</keyword>
  <keyword>Electrophysiology Study</keyword>
  <keyword>EPS</keyword>
  <keyword>Heart block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Heart Block</mesh_term>
    <mesh_term>Aortic Valve Insufficiency</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/NCT04489095
org study id: Frisoli_13944
nct id: NCT04489095
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This is a prospective single center Cardiology department observational study. The study aim
      is to better understand the predictors of high grade conduction abnormalities associated with
      TAVR such that a more robust evidence-based and universal strategy to manage cardiac
      conduction disturbances in these patients, which has been elusive, can be developed.
TAVR is a very commonly performed procedure throughout the world; it has become standard of
      care as the treatment for aortic stenosis and is performed in hundreds of thousands of
      patients annually. TAVR affords patients therapies that prolong life and improve quality of
      life; furthermore, these therapies afford certain patients who are not candidates for
      surgical options hope for the future. Adults undergoing TAVR may suffer the complication of
      requiring a pacemaker after the procedure, in up to 30% of cases. Interventionalists still
      don't understand how to best predict this complication; in fact some patients that ultimately
      need a pacemaker don't get one after the procedure and some that get a pacemaker are found to
      ultimately not have really needed it. A better understanding of which patients do and do not
      need pacemakers will help prevent complications of high grade block in those without
      pacemaker (death, syncope and trauma) and also the complications of unnecessary pacemaker
      implantation (infection, tricuspid regurgitation).

      Primary hypothesis: EP studies (EPS), when performed before and after TAVR adds independent
      incremental value, above and beyond other parameters, for the prediction of high-grade heart
      block after TAVR. The goal is to understand conduction disease changes before and after TAVR,
      coupled with other patient and procedural factors that can help create a management algorithm
      for conduction disease after TAVR.

      Primary endpoint: to find correlation coefficients between a) absolute and delta values of
      various EPS findings, and b) clinical endpoint of high-grade conduction disease as diagnosed
      clinically, by ECG, by event monitor, or by interrogation of permanent pacemaker implanted
      after TAVR.

      Methods: Patients will receive EPS immediately before and after TAVR (while on the
      catheterization lab table for TAVR procedure) and then again the next day; this information
      will help determine whether the patient gets a pacemaker, a 30-day event monitor, or neither.
      The investigators will study which parameters obtained during the EPS, in addition to other
      known/suspected predictors of conduction disease after TAVR, best correlate with serious
      problems with the heart's electrical conduction system as determined by clinical follow-up.

      Anticipated findings: that the EPS findings add incremental and independent value in
      predicting which patients will develop high grade conduction disease.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: After informed consent is obtained, patient will undergo TAVR as per usual standard of care. Using the same femoral vein access as is used standard for a portion of the TAVR procedure, an EPS(Electrophysiology study) will be performed during the TAVR procedure, immediately before and after valve implantation. The patient will recover on a general telemetry floor as per usual care, and the next day will undergo another EPS. This is not uncommonly done clinically for some patients after TAVR. At that point, based on the baseline EKG, intra-procedure findings, and EPS findings, the patient will either have a pacemaker implanted, a 30-day event monitor ordered, or neither of the above.
primary purpose: Diagnostic
masking: None (Open Label)
measure: High grade conduction disease post TAVR
time frame: 1 year
description: Number of participants that develop high grade conduction block post TAVR including complete heart block, 2nd degree AV block, symptomatic bradycardia
measure: death
time frame: 1 year
description: Rate of mortality by chart review and SSDI query at 1 year
measure: rehospitalization
time frame: 1 year
description: Absolute and per patient hospitalizations post index procedure
measure: need for pacemaker implantation
time frame: 1 year
description: Percentage of participants requiring permanent pacemaker implantation in index hospitalization or within 1 year
measure: HV interval pre and post TAVR
time frame: 2 days
description: Absolute HV interval in milliseconds as measure by electrophysiology study for each participant pre and post TAVR
measure: ejection fraction
time frame: 1 year
description: Ejection fraction as measured by trans-thoracic echocardiography for each participant pre and post tavr on routine trans-thoracic echocardiography
arm group label: Electrophysiology Study pre and Post TAVR
arm group type: Experimental
description: In all patient's undergoing TAVR after informed consent will undergo an electrophysiology study pre and post device deployment in order to determine the need for permanent pacemaker implantation or further testing/monitoring.
intervention type: Diagnostic Test
intervention name: Electrophysiology Study
description: After informed consent is obtained, patient will undergo TAVR as per usual standard of care. Using the same femoral vein access as is used standard for a portion of the TAVR procedure, an EPS will be performed during the TAVR procedure, immediately before and after valve implantation. The patient will recover on a general telemetry floor as per usual care, and the next day will undergo another EPS. This is not uncommonly done clinically for some patients after TAVR. At that point, based on the baseline EKG, intra-procedure findings, and EPS findings, the patient will either have a pacemaker implanted, a 30-day event monitor ordered, or neither of the above.
arm group label: Electrophysiology Study pre and Post TAVR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tiberio Frisoli, MD
role: Principal Investigator
affiliation: Henry Ford Health System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Tiberio Frisoli
investigator title: MD Principal Investigator
mesh term: Aortic Valve Stenosis
mesh term: Heart Block
mesh term: Aortic Valve Insufficiency
sharing ipd: No