<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/NCT02195102</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV 2013-12</org_study_id>
    <nct_id>NCT02195102</nct_id>
  </id_info>
  <brief_title>The Asian Pacific TAVR Multicenter Registry</brief_title>
  <acronym>AP TAVR</acronym>
  <official_title>Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Population The Asian Pacific TAVI Multicenter Registry A MULTICENTER, OBSERVATIONAL STUDY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael Kang-Yin Lee, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cardiovascular Clinical Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen Elizabeth Hospital, Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve&#xD;
      Replacement (TAVR) in the Asian Pacific population&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Death from any cause</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Death from any cause</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Death from any cause</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Death from any cause</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Death from any cause</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Death from any cause</measure>
    <time_frame>4 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Death from any cause</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding events</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding events</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding events</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding events</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding events</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding events</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding events</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>1 month</time_frame>
    <description>Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient &lt;20 mmHg or peak velocity &lt; 3 m/s, and no moderate or severe paravalvular regurgitation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>6 months</time_frame>
    <description>Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient &lt;20 mmHg or peak velocity &lt; 3 m/s, and no moderate or severe paravalvular regurgitation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>1 year</time_frame>
    <description>Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient &lt;20 mmHg or peak velocity &lt; 3 m/s, and no moderate or severe paravalvular regurgitation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>2 years</time_frame>
    <description>Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient &lt;20 mmHg or peak velocity &lt; 3 m/s, and no moderate or severe paravalvular regurgitation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>3 years</time_frame>
    <description>Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient &lt;20 mmHg or peak velocity &lt; 3 m/s, and no moderate or severe paravalvular regurgitation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>4 years</time_frame>
    <description>Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient &lt;20 mmHg or peak velocity &lt; 3 m/s, and no moderate or severe paravalvular regurgitation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>5 years</time_frame>
    <description>Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient &lt;20 mmHg or peak velocity &lt; 3 m/s, and no moderate or severe paravalvular regurgitation)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>transcatheter aortic valve Replacement</arm_group_label>
    <description>Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcatheter aortic valve Replacement</intervention_name>
    <arm_group_label>transcatheter aortic valve Replacement</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who had undergone transcatheter aortic valve replacement on the basis of&#xD;
        inclusion criteria were prospectively&amp;retrospectively included in the registry&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic severe aortic stenosis who are not candidates for surgical&#xD;
             aortic valve replacement because of coexisting illnesses.&#xD;
&#xD;
          -  The patient or guardian agrees to the study protocol and the schedule of clinical&#xD;
             follow-up, and provides informed, written consent, as approved by the appropriate&#xD;
             Institutional Review Board/Ethics Committee of the respective clinical site.&#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, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center, Republic of Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edgar L.W. Tay, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University Heart Center (National University Health System), Singapore</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Machael Kang-Yin Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Elizabeth Hospital, HongKong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elly Jeong-youn Bae, Research Nurse</last_name>
    <email>cvcrc10@amc.seoul.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>HongKong</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Michael Kang-Yin Lee, MD</last_name>
      <email>kylee1991@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Michael Kang-Yin Lee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nanjing 1st Hospital</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jun-Jie Zhang, MD</last_name>
      <email>jameszll@163.com</email>
    </contact>
    <investigator>
      <last_name>Jun-Jie Zhang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shonan Kamakura General Hospital</name>
      <address>
        <city>Kamakura</city>
        <country>Japan</country>
      </address>
    </facility>
    <contact>
      <last_name>Shigeru Saito, MD</last_name>
      <email>saito@shonankamakura.or.jp</email>
    </contact>
    <investigator>
      <last_name>Shigeru Saito, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Jeong-youn Bae, Research nurse</last_name>
      <email>cvcrc10@amc.seoul.kr</email>
    </contact>
    <investigator>
      <last_name>Seung-jung Park, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Jantung Negara</name>
      <address>
        <city>Kuala Lumpur</city>
        <country>Malaysia</country>
      </address>
    </facility>
    <contact>
      <last_name>Rosli Mohd Ali, MD</last_name>
      <email>rosli@ijn.com.my</email>
    </contact>
    <investigator>
      <last_name>Rosli Mohd Ali, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Luke's Medical Center</name>
      <address>
        <city>Bonifacio</city>
        <country>Philippines</country>
      </address>
    </facility>
    <contact>
      <last_name>Enrique Fabio Posas, MD</last_name>
      <email>febposas@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Enrique Fabio Posas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Heart Centre of Singapore</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
    <contact>
      <last_name>Paul Chiam, MD</last_name>
      <email>paul.chiam.t.l@nhcs.com.sg</email>
    </contact>
    <investigator>
      <last_name>Paul Chiam, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National University Heart Centre</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
    <contact>
      <last_name>Edgar L.W. Tay, MD</last_name>
      <email>Edgar_Tay@nuhs.edu.sg</email>
    </contact>
    <investigator>
      <last_name>Edgar L.W. Tay, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Taiwan University</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <contact>
      <last_name>Paul Kao, MD</last_name>
      <email>hsienli_kao@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Paul Kao, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>King Chulalongkorn Memorial Hospital</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
    <contact>
      <last_name>Wacin Buddhari, MD</last_name>
      <email>wacin_buddhari@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Wacin Buddhari, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Philippines</country>
    <country>Singapore</country>
    <country>Taiwan</country>
    <country>Thailand</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>November 17, 2014</last_update_submitted>
  <last_update_submitted_qc>November 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Queen Elizabeth Hospital, Hong Kong</investigator_affiliation>
    <investigator_full_name>Michael Kang-Yin Lee, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>transcatheter aortic valve Replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02195102
org study id: AMCCV 2013-12
nct id: NCT02195102
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve
      Replacement (TAVR) in the Asian Pacific population
observational model: Cohort
measure: Death from any cause
time frame: 1 month
measure: Death from any cause
time frame: 6 months
measure: Death from any cause
time frame: 1 year
measure: Death from any cause
time frame: 2 years
measure: Death from any cause
time frame: 3 years
measure: Death from any cause
time frame: 4 years
measure: Death from any cause
time frame: 5 years
measure: Death from cardiac cause
time frame: 1 month
measure: Death from cardiac cause
time frame: 6 months
measure: Death from cardiac cause
time frame: 1 year
measure: Death from cardiac cause
time frame: 2 years
measure: Death from cardiac cause
time frame: 3 years
measure: Death from cardiac cause
time frame: 4 years
measure: Death from cardiac cause
time frame: 5 years
measure: Stroke
time frame: 1 month
measure: Stroke
time frame: 6 months
measure: Stroke
time frame: 1 year
measure: Stroke
time frame: 2 years
measure: Stroke
time frame: 3 years
measure: Stroke
time frame: 4 years
measure: Stroke
time frame: 5 years
measure: Myocardial infarction
time frame: 1 month
measure: Myocardial infarction
time frame: 6 months
measure: Myocardial infarction
time frame: 1 year
measure: Myocardial infarction
time frame: 2 years
measure: Myocardial infarction
time frame: 3 years
measure: Myocardial infarction
time frame: 4 years
measure: Myocardial infarction
time frame: 5 years
measure: Repeat hospitalization
time frame: 1 month
measure: Repeat hospitalization
time frame: 6 months
measure: Repeat hospitalization
time frame: 1 year
measure: Repeat hospitalization
time frame: 2 years
measure: Repeat hospitalization
time frame: 3 years
measure: Repeat hospitalization
time frame: 4 years
measure: Repeat hospitalization
time frame: 5 years
measure: Acute kidney injury
time frame: 1 month
measure: Acute kidney injury
time frame: 6 months
measure: Acute kidney injury
time frame: 1 year
measure: Acute kidney injury
time frame: 2 years
measure: Acute kidney injury
time frame: 3 years
measure: Acute kidney injury
time frame: 4 years
measure: Acute kidney injury
time frame: 5 years
measure: Vascular complication
time frame: 1 month
measure: Vascular complication
time frame: 6 months
measure: Vascular complication
time frame: 1 year
measure: Vascular complication
time frame: 2 years
measure: Vascular complication
time frame: 3 years
measure: Vascular complication
time frame: 4 years
measure: Vascular complication
time frame: 5 years
measure: Bleeding events
time frame: 1 month
measure: Bleeding events
time frame: 6 months
measure: Bleeding events
time frame: 1 year
measure: Bleeding events
time frame: 2 years
measure: Bleeding events
time frame: 3 years
measure: Bleeding events
time frame: 4 years
measure: Bleeding events
time frame: 5 years
measure: Device success
time frame: 1 month
description: Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)
measure: Device success
time frame: 6 months
description: Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)
measure: Device success
time frame: 1 year
description: Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)
measure: Device success
time frame: 2 years
description: Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)
measure: Device success
time frame: 3 years
description: Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)
measure: Device success
time frame: 4 years
description: Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)
measure: Device success
time frame: 5 years
description: Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)
arm group label: transcatheter aortic valve Replacement
description: Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.
intervention type: Device
intervention name: Transcatheter aortic valve Replacement
arm group label: transcatheter aortic valve Replacement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Seung-jung Park, MD, PhD
role: Principal Investigator
affiliation: Asan Medical Center, Republic of Korea
last name: Edgar L.W. Tay, MD
role: Principal Investigator
affiliation: National University Heart Center (National University Health System), Singapore
last name: Machael Kang-Yin Lee, MD
role: Principal Investigator
affiliation: Queen Elizabeth Hospital, HongKong
last name: Elly Jeong-youn Bae, Research Nurse
email: cvcrc10@amc.seoul.kr
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country: China
country: Japan
country: Korea, Republic of
country: Malaysia
country: Philippines
country: Singapore
country: Taiwan
country: Thailand
responsible party type: Sponsor-Investigator
investigator affiliation: Queen Elizabeth Hospital, Hong Kong
investigator full name: Michael Kang-Yin Lee, MD
investigator title: MD
mesh term: Aortic Valve Stenosis