<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/NCT03797820</url>
  </required_header>
  <id_info>
    <org_study_id>SAHZJU CT012</org_study_id>
    <nct_id>NCT03797820</nct_id>
  </id_info>
  <brief_title>Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）</brief_title>
  <official_title>A Prospective, Multicenter,Registry Study of Aortic Valve Stenosis in Zhejiang Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Affiliated Hospital of Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jinhua Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Jiaxing University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Fourth Affiliated Hospital of Zhejiang University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Central Hospital of Lishui City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sir Run Run Shaw Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ningbo Medical Center Lihuili Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ningbo No. 1 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aortic valve stenosis (AVS) is becoming more and more frequent with the aging, which has&#xD;
      brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart&#xD;
      disease are not so clear, especially in the developing countries such as China etc. Because&#xD;
      of the slow and progressive nature of AVS, symptoms might not be too severe to be diagnosed&#xD;
      on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe aortic&#xD;
      valve stenosis are very common in China. Hence, we design a prospective, observational cohort&#xD;
      study to provide contemporary information on the prevalence, characteristics, risk&#xD;
      stratification，cost-effective ,treatments and prognosis of Chinese elderly patients with&#xD;
      aortic valve stenosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>All-cause mortality,disabling strokes and Surgical or transcatheter aortic valve replacement</measure>
    <time_frame>one year</time_frame>
    <description>time from enrolled to first occurrence of any of the components of the composite outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for heart failure</measure>
    <time_frame>one year</time_frame>
    <description>time from enrolled to first occurrence of the outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical or transcatheter aortic valve replacement</measure>
    <time_frame>one year</time_frame>
    <description>time from enrolled to first occurrence of the outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular death</measure>
    <time_frame>one year</time_frame>
    <description>time from enrolled to first occurrence of the outcome</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1</enrollment>
  <condition>Valvular Heart Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Our study type is observational</intervention_name>
    <description>Our study type is observational</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients over 60 years old and moderate or above aortic stenosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Patients over 60 years old meet the following condition moderate or above aortic&#xD;
        stenosis as defined by echocardiography: Aortic stenosis, moderate or above, or valve&#xD;
        area≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient≥20mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients cannot be followed up for any reasons.&#xD;
&#xD;
          2. Patients in critical condition may be die in one year.&#xD;
&#xD;
          3. Patients have been enrolled in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Second Affiliated Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xianbao Liu, MD</last_name>
      <phone>+86-13857173887</phone>
      <email>liuxb2009@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/27908608</url>
    <description>A hospital-based survey of patients with severe valvular heart disease in China</description>
  </link>
  <reference>
    <citation>Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, Wang JA. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol. 2017 Mar 15;231:244-247. doi: 10.1016/j.ijcard.2016.11.301. Epub 2016 Nov 25.</citation>
    <PMID>27908608</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>July 14, 2021</last_update_submitted>
  <last_update_submitted_qc>July 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_affiliation>
    <investigator_full_name>Jian'an Wang,MD,PhD</investigator_full_name>
    <investigator_title>President of Second Affiliated Hospital, School of Medicine, Zhejiang University &amp; Chief of Cardiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Heart Valve Diseases</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/NCT03797820
org study id: SAHZJU CT012
nct id: NCT03797820
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aortic valve stenosis (AVS) is becoming more and more frequent with the aging, which has
      brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart
      disease are not so clear, especially in the developing countries such as China etc. Because
      of the slow and progressive nature of AVS, symptoms might not be too severe to be diagnosed
      on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe aortic
      valve stenosis are very common in China. Hence, we design a prospective, observational cohort
      study to provide contemporary information on the prevalence, characteristics, risk
      stratification，cost-effective ,treatments and prognosis of Chinese elderly patients with
      aortic valve stenosis.
observational model: Cohort
time perspective: Prospective
measure: All-cause mortality,disabling strokes and Surgical or transcatheter aortic valve replacement
time frame: one year
description: time from enrolled to first occurrence of any of the components of the composite outcome
measure: Hospitalization for heart failure
time frame: one year
description: time from enrolled to first occurrence of the outcome
measure: Surgical or transcatheter aortic valve replacement
time frame: one year
description: time from enrolled to first occurrence of the outcome
measure: Cardiovascular death
time frame: one year
description: time from enrolled to first occurrence of the outcome
intervention type: Other
intervention name: Our study type is observational
description: Our study type is observational
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
url: http://www.ncbi.nlm.nih.gov/pubmed/27908608
description: A hospital-based survey of patients with severe valvular heart disease in China
citation: Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, Wang JA. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol. 2017 Mar 15;231:244-247. doi: 10.1016/j.ijcard.2016.11.301. Epub 2016 Nov 25.
PMID: 27908608
responsible party type: Principal Investigator
investigator affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
investigator full name: Jian'an Wang,MD,PhD
investigator title: President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology
mesh term: Heart Diseases
mesh term: Aortic Valve Stenosis
mesh term: Heart Valve Diseases