<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/NCT03826264</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV2019-01</org_study_id>
    <nct_id>NCT03826264</nct_id>
  </id_info>
  <brief_title>Transpacific TAVR Registry</brief_title>
  <acronym>TP-TAVR</acronym>
  <official_title>a Multinational Multicenter Prospective Transpacific TAVR Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duk-Woo Park, MD</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 registry evaluates the long-term outcome of Transcatheter aortic valve replacement&#xD;
      (TAVR) in real-world clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is connected with Asian TAVR registry(NCT02308150). Some subjects from Asian TAVR&#xD;
      registry continue 10 years follow-up on this TP-TAVR registry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 15, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2031</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>Event rate of all cause death</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Event rate of cardiovascular death</measure>
    <time_frame>10 years</time_frame>
    <description>A. Death due to proximate cardiac cause B. Death caused by non-coronary vascular condition C. All procedure-related death D. All valve-related death E. Sudden or unwitnessed death F. Death of unknown cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of myocardial infarction</measure>
    <time_frame>10 years</time_frame>
    <description>according to Valve Academic Research Consortium (VARC) criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of cerebrovascular accident</measure>
    <time_frame>10 years</time_frame>
    <description>stroke and TIA (Transient Ischemic Attack)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of bleeding</measure>
    <time_frame>10 years</time_frame>
    <description>according to Valve Academic Research Consortium (VARC) criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of Vascular access site and access-related complication</measure>
    <time_frame>30 days</time_frame>
    <description>according to Valve Academic Research Consortium (VARC) criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of Acute kidney injury</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of Permanent pacemaker insertion</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of Other TAVR-related complication</measure>
    <time_frame>10 years</time_frame>
    <description>A. Conversion to open surgery B. Coronary obstruction C. Mitral valve apparatus damage or dysfunction D. Cardiac tamponade E. Endocarditis F. Valve thrombosis G. Valve mal-positioning H. TAV-in-TAV deployment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of Prosthetic valve dysfunction</measure>
    <time_frame>10 years</time_frame>
    <description>according to Valve Academic Research Consortium (VARC) criteria&#xD;
A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of Composite endpoint</measure>
    <time_frame>10 years</time_frame>
    <description>A. Device success&#xD;
B. Early safety&#xD;
: death, cerebrovascular event, fatal bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve dysfunction requiring intervention&#xD;
C. Clinical efficacy : death, cerebrovascular event, valve-related symptom requiring hospitalization or devastating heart failure, NYHA class* III, IV dyspnea, valve dysfunction&#xD;
*the New York Heart Association (NYHA) Functional Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of Structural valve deterioration</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NYHA class</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NYHA class</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Valve area</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of free from atrial fibrillation</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Heart Valve Diseases</condition>
  <condition>Aortic Valve Insufficiency</condition>
  <arm_group>
    <arm_group_label>Korea Centers</arm_group_label>
    <description>Seoul, Korea All Patients undergoing TAVR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stanford University</arm_group_label>
    <description>California, USA All Patients undergoing TAVR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Northwestern University</arm_group_label>
    <description>Evanston, Illinois, USA All Patients undergoing TAVR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cheng-Hsin Hospital</arm_group_label>
    <description>Taipei, Taiwan All Patients undergoing TAVR</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAVR</intervention_name>
    <description>transcatheter aortic valve replacement (TAVR)</description>
    <arm_group_label>Cheng-Hsin Hospital</arm_group_label>
    <arm_group_label>Korea Centers</arm_group_label>
    <arm_group_label>Northwestern University</arm_group_label>
    <arm_group_label>Stanford University</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing TAVR&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing TAVR&#xD;
&#xD;
          -  Informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Alan Ching Yuen Yeung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James D. Flaherty, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Duk-woo Park, MD</last_name>
    <phone>82230103995</phone>
    <email>dwpark@amc.seoul.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Do-yoon Kang, MD</last_name>
    <email>kdy1218@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alan Ching Yuen Yeung, MD</last_name>
    </contact>
    <investigator>
      <last_name>Alan Ching Yuenn Yeung, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James D. Flaherty, MD</last_name>
    </contact>
    <investigator>
      <last_name>James D. Flaherty, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian-an Wang, MD</last_name>
    </contact>
    <investigator>
      <last_name>Jian-an Wang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bucheon Sejong Hospital</name>
      <address>
        <city>Bucheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jae-hyung Park, MD</last_name>
    </contact>
    <investigator>
      <last_name>Jae-hyung Park, 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>
    <status>Recruiting</status>
    <contact>
      <last_name>Duk-woo Park, MD</last_name>
      <email>dwpark@amc.seoul.kr</email>
    </contact>
    <investigator>
      <last_name>Duk-woo Park, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>China</country>
    <country>Korea, Republic of</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Taiwan</country>
  </removed_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Duk-Woo Park, MD</investigator_full_name>
    <investigator_title>Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea</investigator_title>
  </responsible_party>
  <keyword>TAVR</keyword>
  <keyword>TAVI</keyword>
  <keyword>real-world</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Valve Diseases</mesh_term>
    <mesh_term>Aortic Valve Insufficiency</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/NCT03826264
org study id: AMCCV2019-01
nct id: NCT03826264
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This registry evaluates the long-term outcome of Transcatheter aortic valve replacement
      (TAVR) in real-world clinical practice.
This study is connected with Asian TAVR registry(NCT02308150). Some subjects from Asian TAVR
      registry continue 10 years follow-up on this TP-TAVR registry.
observational model: Cohort
time perspective: Prospective
measure: Event rate of all cause death
time frame: 1 year
measure: Event rate of cardiovascular death
time frame: 10 years
description: A. Death due to proximate cardiac cause B. Death caused by non-coronary vascular condition C. All procedure-related death D. All valve-related death E. Sudden or unwitnessed death F. Death of unknown cause
measure: Event rate of myocardial infarction
time frame: 10 years
description: according to Valve Academic Research Consortium (VARC) criteria
measure: Event rate of cerebrovascular accident
time frame: 10 years
description: stroke and TIA (Transient Ischemic Attack)
measure: Event rate of bleeding
time frame: 10 years
description: according to Valve Academic Research Consortium (VARC) criteria
measure: Event rate of Vascular access site and access-related complication
time frame: 30 days
description: according to Valve Academic Research Consortium (VARC) criteria
measure: Event rate of Acute kidney injury
time frame: 30 days
measure: Event rate of Permanent pacemaker insertion
time frame: 10 years
measure: Event rate of Other TAVR-related complication
time frame: 10 years
description: A. Conversion to open surgery B. Coronary obstruction C. Mitral valve apparatus damage or dysfunction D. Cardiac tamponade E. Endocarditis F. Valve thrombosis G. Valve mal-positioning H. TAV-in-TAV deployment
measure: Event rate of Prosthetic valve dysfunction
time frame: 10 years
description: according to Valve Academic Research Consortium (VARC) criteria
A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation
measure: Event rate of Composite endpoint
time frame: 10 years
description: A. Device success
B. Early safety
: death, cerebrovascular event, fatal bleeding, acute kidney injury, coronary obstruction requiring intervention, major vascular complication, valve dysfunction requiring intervention
C. Clinical efficacy : death, cerebrovascular event, valve-related symptom requiring hospitalization or devastating heart failure, NYHA class* III, IV dyspnea, valve dysfunction
*the New York Heart Association (NYHA) Functional Classification
measure: Event rate of Structural valve deterioration
time frame: 10 years
measure: NYHA class
time frame: 30 days
measure: NYHA class
time frame: 1 year
measure: Valve area
time frame: 1 year
measure: Event rate of free from atrial fibrillation
time frame: 10 years
arm group label: Korea Centers
description: Seoul, Korea All Patients undergoing TAVR
arm group label: Stanford University
description: California, USA All Patients undergoing TAVR
arm group label: Northwestern University
description: Evanston, Illinois, USA All Patients undergoing TAVR
arm group label: Cheng-Hsin Hospital
description: Taipei, Taiwan All Patients undergoing TAVR
intervention type: Procedure
intervention name: TAVR
description: transcatheter aortic valve replacement (TAVR)
arm group label: Cheng-Hsin Hospital
arm group label: Korea Centers
arm group label: Northwestern University
arm group label: Stanford University
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
last name: Alan Ching Yuen Yeung, MD
role: Principal Investigator
affiliation: Stanford University
last name: James D. Flaherty, MD
role: Principal Investigator
affiliation: Northwestern University
last name: Duk-woo Park, MD
phone: 82230103995
email: dwpark@amc.seoul.kr
last name: Do-yoon Kang, MD
email: kdy1218@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
country: China
country: Korea, Republic of
country: United States
country: Taiwan
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: Duk-Woo Park, MD
investigator title: Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
mesh term: Heart Valve Diseases
mesh term: Aortic Valve Insufficiency
sharing ipd: Undecided