<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/NCT03298178</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV 2017-09</org_study_id>
    <nct_id>NCT03298178</nct_id>
  </id_info>
  <brief_title>ASAN Medical Center Aortic Valve Replacement Registry</brief_title>
  <acronym>ASAN-AVR</acronym>
  <official_title>ASAN Medical Center Aortic Valve Replacement Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ho-Jin Kim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CardioVascular Research Foundation, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Asan Medical Center</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>
      This study evaluates the effectiveness and safety of surgical aortic valve replacement and&#xD;
      transcatheter aortic valve replacement in aortic Stenosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All TAVR and SAVR cases will be enrolled retrospectively and prospectively.&#xD;
&#xD;
      This registry includes sub group analysis named STRATEGY AS(Role of Sarcopenia and frailTy in&#xD;
      pRedicting outcomes After TranscathEter or surGical aortic valve replacement in elderlY&#xD;
      patients with Aortic Stenosis: A prospective cohort study). For this sub group analysis, all&#xD;
      enrolled subjects will have following tests : EQ-5D, KCCQ-12(Kansas City Cardiomyopathy&#xD;
      Questionnaire), ADL(Activities of daily living), IADL(Instrumental. Activities of Daily&#xD;
      Living), Nagi &amp; Rosow-Breslau self-reported items, Previous fall events since 6 months&#xD;
      (initial) or last visit(F/U), IPAQ(The International Physical Activity Questionnaires),&#xD;
      Social frailty screening, CES-D(Center for Epidemiologic Studies Depression Scale),&#xD;
      MNA-SF(Mini Nutritional Assessment - Short Form),SPPB score (Short Physical Performance&#xD;
      Battery, usual gait speed, balance, chairstand), Multi-task gait test (counting7, animal,&#xD;
      motor, motor&amp;counting7), Grip strength, Bioimpedance analysis, Muscle tone at thigh and calf,&#xD;
      UEF (Upper extremities function).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">December 2031</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2030</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>All cause death</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular mortality</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular mortality</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
    <description>Death due to proximate cardiac cause Death caused by noncoronary vascular condition All procedure-related/surgery-related death All valve-related death Sudden or unwitnessed death Death of unknown cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
    <description>all stroke and TIA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operation site complication</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular access site and access-related complication</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>at a later date between 30 days or discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of permanent pacemaker insertion</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other TAVR-related complication</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
    <description>Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment(TAV : Transcatheter Aortic Valve)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosthetic valve dysfunction</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
    <description>Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of composite endpoint</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
    <description>Device success Early safety within 30 days Clinical efficacy after 30 days defined as death, stroke, valve dysfunction or heart failure requiring hospitalization, severe dyspnea or valve dysfunction NYHA class III or IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Structural valve deterioration</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of NYHA class</measure>
    <time_frame>30 days and 1 year</time_frame>
    <description>the New York Heart Association (NYHA) Functional Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of valve area</measure>
    <time_frame>30 days and 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Free from atrial fibrillation</measure>
    <time_frame>1,6 and 12 months and 5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>all aortic stenosis</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAVR</intervention_name>
    <description>All patients who underwent transcatheter aortic valve replacement in Asan medical center, republic of Korea</description>
    <arm_group_label>all aortic stenosis</arm_group_label>
    <other_name>transcatheter aortic valve replacement</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SAVR</intervention_name>
    <description>All patients who underwent surgical aortic valve replacement in Asan medical center, republic of Korea</description>
    <arm_group_label>all aortic stenosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All successful transcatheter aortic valve replacement or surgical aortic valve replacement&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All successful transcatheter aortic valve replacement or surgical aortic valve&#xD;
             replacement&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Infective endocarditis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seung-jung Park, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Do-yoon Kang, MD</last_name>
    <phone>82230101745</phone>
    <email>kdy1218@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Asan Medical Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suk-jung Choo, MD</last_name>
      <email>sjchoo@amc.seoul.kr</email>
    </contact>
    <investigator>
      <last_name>Suk-jung Choo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Ho-Jin Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>TAVR</keyword>
  <keyword>TAVI</keyword>
  <keyword>SAVR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03298178
org study id: AMCCV 2017-09
nct id: NCT03298178
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effectiveness and safety of surgical aortic valve replacement and
      transcatheter aortic valve replacement in aortic Stenosis.
All TAVR and SAVR cases will be enrolled retrospectively and prospectively.

      This registry includes sub group analysis named STRATEGY AS(Role of Sarcopenia and frailTy in
      pRedicting outcomes After TranscathEter or surGical aortic valve replacement in elderlY
      patients with Aortic Stenosis: A prospective cohort study). For this sub group analysis, all
      enrolled subjects will have following tests : EQ-5D, KCCQ-12(Kansas City Cardiomyopathy
      Questionnaire), ADL(Activities of daily living), IADL(Instrumental. Activities of Daily
      Living), Nagi & Rosow-Breslau self-reported items, Previous fall events since 6 months
      (initial) or last visit(F/U), IPAQ(The International Physical Activity Questionnaires),
      Social frailty screening, CES-D(Center for Epidemiologic Studies Depression Scale),
      MNA-SF(Mini Nutritional Assessment - Short Form),SPPB score (Short Physical Performance
      Battery, usual gait speed, balance, chairstand), Multi-task gait test (counting7, animal,
      motor, motor&counting7), Grip strength, Bioimpedance analysis, Muscle tone at thigh and calf,
      UEF (Upper extremities function).
observational model: Cohort
time perspective: Prospective
measure: All cause death
time frame: 1 year
measure: Cardiovascular mortality
time frame: 1,6 and 12 months and 5 years
measure: Cardiovascular mortality
time frame: 1,6 and 12 months and 5 years
description: Death due to proximate cardiac cause Death caused by noncoronary vascular condition All procedure-related/surgery-related death All valve-related death Sudden or unwitnessed death Death of unknown cause
measure: Myocardial infarction
time frame: 1,6 and 12 months and 5 years
measure: Stroke
time frame: 1,6 and 12 months and 5 years
description: all stroke and TIA
measure: Bleeding
time frame: 1,6 and 12 months and 5 years
measure: Operation site complication
time frame: 1,6 and 12 months and 5 years
measure: Vascular access site and access-related complication
time frame: 1,6 and 12 months and 5 years
measure: Acute kidney injury
time frame: at a later date between 30 days or discharge
measure: Event rate of permanent pacemaker insertion
time frame: 1,6 and 12 months and 5 years
measure: Other TAVR-related complication
time frame: 1,6 and 12 months and 5 years
description: Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment(TAV : Transcatheter Aortic Valve)
measure: Prosthetic valve dysfunction
time frame: 1,6 and 12 months and 5 years
description: Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation
measure: Event rate of composite endpoint
time frame: 1,6 and 12 months and 5 years
description: Device success Early safety within 30 days Clinical efficacy after 30 days defined as death, stroke, valve dysfunction or heart failure requiring hospitalization, severe dyspnea or valve dysfunction NYHA class III or IV
measure: Structural valve deterioration
time frame: 1,6 and 12 months and 5 years
measure: Change of NYHA class
time frame: 30 days and 1 year
description: the New York Heart Association (NYHA) Functional Classification
measure: Change of valve area
time frame: 30 days and 1 year
measure: Free from atrial fibrillation
time frame: 1,6 and 12 months and 5 years
arm group label: all aortic stenosis
intervention type: Procedure
intervention name: TAVR
description: All patients who underwent transcatheter aortic valve replacement in Asan medical center, republic of Korea
arm group label: all aortic stenosis
other name: transcatheter aortic valve replacement
intervention type: Procedure
intervention name: SAVR
description: All patients who underwent surgical aortic valve replacement in Asan medical center, republic of Korea
arm group label: all aortic stenosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Seung-jung Park, MD
role: Principal Investigator
affiliation: Asan Medical Center
last name: Do-yoon Kang, MD
phone: 82230101745
email: kdy1218@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: Ho-Jin Kim
investigator title: Professor
mesh term: Aortic Valve Stenosis
sharing ipd: Undecided