<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/NCT04482816</url>
  </required_header>
  <id_info>
    <org_study_id>PHYS-TAVI TRIAL</org_study_id>
    <nct_id>NCT04482816</nct_id>
  </id_info>
  <brief_title>Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI</brief_title>
  <acronym>PHYS-TAVI</acronym>
  <official_title>Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post-TAVI (PHYS-TAVI Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Josep Lluis Mont Girbau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Single-center randomized trial in patients with pacing indication (AV block) after TAVI&#xD;
      (transfemoral aortic valve implantation) and LVEF&gt; 50%, that aims to study the percentage of&#xD;
      patients who improve at 12 months in a combined clinical endpoint.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is currently no evidence of the best mode of definitive pacing after TAVI in patients&#xD;
      with preserved systolic ventricular function and AV block. Through this study, investigators&#xD;
      intend to elucidate the best post TAVI pacing strategy, comparing the effect of right apical&#xD;
      pacing vs. physiological pacing on the evolution of both echocardiographic and clinical&#xD;
      parameters.&#xD;
&#xD;
      Investigators will include 24 patients without ventricular dysfunction (LVEF&gt; 50%) and with&#xD;
      AV block pacing indication after TAVI.&#xD;
&#xD;
      Patients will be randomized to 2 types of pacing (parallel randomized trial): physiological&#xD;
      or right ventricular pacing (conventional).&#xD;
&#xD;
      PHYS-TAVI trial will analyze the following parameters in the 2 groups: survival; NYHA class;&#xD;
      distance in the 6-minute walking test; hospital admissions; left ventricular function;&#xD;
      echocardiographic asynchrony (strain and flash septal); NTproBNP; and quality of&#xD;
      life/symptoms with the Kansas City Cardiomyopathy Questionnaire test (KCCQ-12)&#xD;
&#xD;
      Clinical, and echocardiographic follow-up will be performed for 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Actual">June 30, 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The patient will be explained to be randomized to either of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits, it will not be said which therapy has been applied.&#xD;
The echocardiographer and the follow-up by the Hemodynamic Team will be blind.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical combined endpoint: survival; and improvement &gt; 1 point in NYHA class or &gt; 25% increase in the distance covered in the 6-minute walking test.</measure>
    <time_frame>12 months</time_frame>
    <description>Determine the percentage of patients who improve at 12 months on a clinical combined endpoint: survival; and improvement &gt; 1 point in NYHA class or &gt; 25% increase in the distance covered in the 6-minute walking test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in left ventricular ejection fraction.</measure>
    <time_frame>12 months</time_frame>
    <description>Left ventricular ejection fraction (LVEF %) measured with Simpson method with echocardiography (Delta left ventricular ejection fraction: 12 months LVEF - baseline LVEF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correction of echocardiographic asynchrony: septal flash expressed in mm.</measure>
    <time_frame>30 days; 12 months</time_frame>
    <description>Correction of septal flash determined with echocardiography (M mode).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance covered in the 6-minute walking test.</measure>
    <time_frame>30 days; 12 months</time_frame>
    <description>Distance in meters walked in 6 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NYHA functional class.</measure>
    <time_frame>30 days; 12 months</time_frame>
    <description>NYHA functional class I, II, III, IV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in degree of mitral regurgitation.</measure>
    <time_frame>12 months</time_frame>
    <description>Mitral regurgitation measured with echocardiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NTproBNP.</measure>
    <time_frame>30 days; 12 months</time_frame>
    <description>NTproBNP blood levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization due to heart failure.</measure>
    <time_frame>12 months</time_frame>
    <description>Hospitalization: patient hospitalization (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QRS duration</measure>
    <time_frame>Implant; 12 months</time_frame>
    <description>QRS duration (milliseconds) measured with a 12-lead ECG (in the electrophysiology lab polygraph)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire )</measure>
    <time_frame>30 days; 12 months</time_frame>
    <description>Score in KCCQ-12: 23 items; scores 1 - 100 (higher=better).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correction of global longitudinal strain</measure>
    <time_frame>30 days; 12 months</time_frame>
    <description>Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Transcatheter Aortic Valve Implantation</condition>
  <condition>Physiological Pacing</condition>
  <condition>Right Ventricular Pacing</condition>
  <condition>AV Block</condition>
  <arm_group>
    <arm_group_label>Physiological pacing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lead placed in the His-Purkinje system (his or branch) in order to achieve QRS shortening and physiologic pacing. A backup lead will be implanted in the right ventricle.&#xD;
If hisian pacing is not achieved (QRS is not shortened &gt; 20% or QRS is not &lt;130ms), the left bundle branch will be paced according to the criteria established in the literature (right branch block and intrinsic deflection &lt;85ms).&#xD;
Crossover from physiological pacing to right ventricular pacing will be allowed in the following situations: failed physiological pacing lead implantation; high thresholds (&gt;3.5V / 1ms); no shortening of QRS (shortening &lt;20%) or failure to meet non-selective HBP criteria or left bundle branch pacing criteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Right ventricular pacing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lead placed in the right ventricle (conventional pacing).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Physiological pacing</intervention_name>
    <description>Pacing of the his bundle or the left bundle branch</description>
    <arm_group_label>Physiological pacing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Right ventricular pacing</intervention_name>
    <description>Conventional pacing; right ventricular pacing</description>
    <arm_group_label>Right ventricular pacing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Successful implantation of TAVI according to VARC-2 criteria.&#xD;
&#xD;
          -  Indication of cardiac pacing due to AV block according to ESC Guidelines.&#xD;
&#xD;
          -  LVEF&gt; 50%.&#xD;
&#xD;
          -  The patient must indicate their acceptance to participate in the study by signing an&#xD;
             informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ventricular dysfunction: LVEF &lt;50%.&#xD;
&#xD;
          -  Transapical TAVI.&#xD;
&#xD;
          -  Participating currently in a clinical investigation that includes an active treatment.&#xD;
&#xD;
          -  Patients with left bundle branch block but without indication of pacing (AV block).&#xD;
&#xD;
          -  Life expectancy &lt;12 months.&#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>José M Tolosana, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Margarida Pujol Lopez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lluís Mont, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eduard Guasch, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Josep Lluis Mont Girbau</investigator_full_name>
    <investigator_title>Head of Arrhythmia Section. Professor of Cardiology</investigator_title>
  </responsible_party>
  <keyword>TAVI</keyword>
  <keyword>Physiological Pacing</keyword>
  <keyword>AV Block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>


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/NCT04482816
org study id: PHYS-TAVI TRIAL
nct id: NCT04482816
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Single-center randomized trial in patients with pacing indication (AV block) after TAVI
      (transfemoral aortic valve implantation) and LVEF> 50%, that aims to study the percentage of
      patients who improve at 12 months in a combined clinical endpoint.
There is currently no evidence of the best mode of definitive pacing after TAVI in patients
      with preserved systolic ventricular function and AV block. Through this study, investigators
      intend to elucidate the best post TAVI pacing strategy, comparing the effect of right apical
      pacing vs. physiological pacing on the evolution of both echocardiographic and clinical
      parameters.

      Investigators will include 24 patients without ventricular dysfunction (LVEF> 50%) and with
      AV block pacing indication after TAVI.

      Patients will be randomized to 2 types of pacing (parallel randomized trial): physiological
      or right ventricular pacing (conventional).

      PHYS-TAVI trial will analyze the following parameters in the 2 groups: survival; NYHA class;
      distance in the 6-minute walking test; hospital admissions; left ventricular function;
      echocardiographic asynchrony (strain and flash septal); NTproBNP; and quality of
      life/symptoms with the Kansas City Cardiomyopathy Questionnaire test (KCCQ-12)

      Clinical, and echocardiographic follow-up will be performed for 1 year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The patient will be explained to be randomized to either of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits, it will not be said which therapy has been applied.
The echocardiographer and the follow-up by the Hemodynamic Team will be blind.
measure: Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.
time frame: 12 months
description: Determine the percentage of patients who improve at 12 months on a clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.
measure: Change in left ventricular ejection fraction.
time frame: 12 months
description: Left ventricular ejection fraction (LVEF %) measured with Simpson method with echocardiography (Delta left ventricular ejection fraction: 12 months LVEF - baseline LVEF).
measure: Correction of echocardiographic asynchrony: septal flash expressed in mm.
time frame: 30 days; 12 months
description: Correction of septal flash determined with echocardiography (M mode).
measure: Distance covered in the 6-minute walking test.
time frame: 30 days; 12 months
description: Distance in meters walked in 6 minutes.
measure: Change in NYHA functional class.
time frame: 30 days; 12 months
description: NYHA functional class I, II, III, IV.
measure: Change in degree of mitral regurgitation.
time frame: 12 months
description: Mitral regurgitation measured with echocardiography.
measure: Change in NTproBNP.
time frame: 30 days; 12 months
description: NTproBNP blood levels.
measure: Hospitalization due to heart failure.
time frame: 12 months
description: Hospitalization: patient hospitalization (yes/no).
measure: QRS duration
time frame: Implant; 12 months
description: QRS duration (milliseconds) measured with a 12-lead ECG (in the electrophysiology lab polygraph)
measure: Score on quality of life/symptoms Questionnaire (KCCQ-12 Kansas City Cardiomyopathy Questionnaire )
time frame: 30 days; 12 months
description: Score in KCCQ-12: 23 items; scores 1 - 100 (higher=better).
measure: Correction of global longitudinal strain
time frame: 30 days; 12 months
description: Global longitudinal strain assessed with two-dimensional speckle-tracking echocardiography
arm group label: Physiological pacing
arm group type: Experimental
description: Lead placed in the His-Purkinje system (his or branch) in order to achieve QRS shortening and physiologic pacing. A backup lead will be implanted in the right ventricle.
If hisian pacing is not achieved (QRS is not shortened > 20% or QRS is not <130ms), the left bundle branch will be paced according to the criteria established in the literature (right branch block and intrinsic deflection <85ms).
Crossover from physiological pacing to right ventricular pacing will be allowed in the following situations: failed physiological pacing lead implantation; high thresholds (>3.5V / 1ms); no shortening of QRS (shortening <20%) or failure to meet non-selective HBP criteria or left bundle branch pacing criteria.
arm group label: Right ventricular pacing
arm group type: Active Comparator
description: Lead placed in the right ventricle (conventional pacing).
intervention type: Device
intervention name: Physiological pacing
description: Pacing of the his bundle or the left bundle branch
arm group label: Physiological pacing
intervention type: Device
intervention name: Right ventricular pacing
description: Conventional pacing; right ventricular pacing
arm group label: Right ventricular pacing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: José M Tolosana, MD, PhD
role: Principal Investigator
affiliation: Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
last name: Margarida Pujol Lopez, MD
role: Principal Investigator
affiliation: Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
last name: Lluís Mont, MD, PhD
role: Study Director
affiliation: Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
last name: Eduard Guasch, MD, PhD
role: Study Chair
affiliation: Institut Clínic Cardiovascular (ICCV), Hospital Clínic Barcelona.
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Josep Lluis Mont Girbau
investigator title: Head of Arrhythmia Section. Professor of Cardiology
mesh term: Atrioventricular Block
sharing ipd: No