<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/NCT03836521</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00047203</org_study_id>
    <nct_id>NCT03836521</nct_id>
  </id_info>
  <brief_title>Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry</brief_title>
  <official_title>The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the procedural and clinical outcomes of patients&#xD;
      with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 15, 2016</start_date>
  <completion_date type="Anticipated">August 15, 2028</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2028</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>Death</measure>
    <time_frame>1 month</time_frame>
    <description>Death from any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>1 year</time_frame>
    <description>Death from any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>2 years</time_frame>
    <description>Death from any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>3 years</time_frame>
    <description>Death from any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>4 years</time_frame>
    <description>Death from any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>5 years</time_frame>
    <description>Death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>1 month</time_frame>
    <description>Death from cardiac cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>1 year</time_frame>
    <description>Death from cardiac cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>2 years</time_frame>
    <description>Death from cardiac cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>3 years</time_frame>
    <description>Death from cardiac cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>4 years</time_frame>
    <description>Death from cardiac cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from cardiac cause</measure>
    <time_frame>5 years</time_frame>
    <description>Death from cardiac cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>1 month</time_frame>
    <description>disabling and non-disabling stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>1 year</time_frame>
    <description>disabling and non-disabling stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>2 years</time_frame>
    <description>disabling and non-disabling stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>3 years</time_frame>
    <description>disabling and non-disabling stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>4 years</time_frame>
    <description>disabling and non-disabling stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>5 years</time_frame>
    <description>disabling and non-disabling stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>1 month</time_frame>
    <description>Number of hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>1 year</time_frame>
    <description>Number of hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>2 years</time_frame>
    <description>Number of hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>3 years</time_frame>
    <description>Number of hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>4 years</time_frame>
    <description>Number of hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>5 years</time_frame>
    <description>Number of hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>1 month</time_frame>
    <description>Life-threatening or major bleeding rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>1 year</time_frame>
    <description>Life-threatening or major bleeding rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>2 years</time_frame>
    <description>Life-threatening or major bleeding rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>3 years</time_frame>
    <description>Life-threatening or major bleeding rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>4 years</time_frame>
    <description>Life-threatening or major bleeding rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>5 years</time_frame>
    <description>Life-threatening or major bleeding rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>1 month</time_frame>
    <description>Major vascular complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>1 year</time_frame>
    <description>Major vascular complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>2 years</time_frame>
    <description>Major vascular complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>3 years</time_frame>
    <description>Major vascular complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>4 years</time_frame>
    <description>Major vascular complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular complication</measure>
    <time_frame>5 years</time_frame>
    <description>Major vascular complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury (stage 2 or 3)</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury (stage 2 or 3)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury (stage 2 or 3)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury (stage 2 or 3)</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury (stage 2 or 3)</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury (stage 2 or 3)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosthetic regurgitation by Doppler echocardiography</measure>
    <time_frame>at discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosthetic regurgitation by Doppler echocardiography</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosthetic regurgitation by Doppler echocardiography</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosthetic regurgitation by Doppler echocardiography</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosthetic regurgitation by Doppler echocardiography</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosthetic regurgitation by Doppler echocardiography</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosthetic regurgitation by Doppler echocardiography</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean aortic valve gradient by Doppler echocardiography</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean aortic valve gradient by Doppler echocardiography</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean aortic valve gradient by Doppler echocardiography</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean aortic valve gradient by Doppler echocardiography</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean aortic valve gradient by Doppler echocardiography</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean aortic valve gradient by Doppler echocardiography</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Bicuspid Aortic Valve</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcatheter aortic valve replacement</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients presenting with severe and symptomatic bicuspid aortic valve&#xD;
        stenosis or mixed disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age≥18 years.&#xD;
&#xD;
          2. Severe aortic stenosis with bicuspid anatomy.&#xD;
&#xD;
          3. NYHA≥2 and/or syncope and/or angina.&#xD;
&#xD;
          4. Patient judged by the Heart Team as indicated for TAVR.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt;18 years&#xD;
&#xD;
          2. Asymptomatic patients&#xD;
&#xD;
          3. Pure aortic regurgitation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>129 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sung-Han Yoon, M.D.</last_name>
    <phone>3104237426</phone>
    <email>Sunghan.Yoon@cshs.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sung-Han Yoon, M.D.</last_name>
      <phone>310-423-7426</phone>
      <email>Sunghan.Yoon@cshs.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Raj Makkar</investigator_full_name>
    <investigator_title>Profssor of Medicine, University of California</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Bicuspid Aortic Valve Disease</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/NCT03836521
org study id: Pro00047203
nct id: NCT03836521
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objective of this study is to evaluate the procedural and clinical outcomes of patients
      with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.
observational model: Cohort
time perspective: Prospective
measure: Death
time frame: 1 month
description: Death from any cause
measure: Death
time frame: 1 year
description: Death from any cause
measure: Death
time frame: 2 years
description: Death from any cause
measure: Death
time frame: 3 years
description: Death from any cause
measure: Death
time frame: 4 years
description: Death from any cause
measure: Death
time frame: 5 years
description: Death from any cause
measure: Death from cardiac cause
time frame: 1 month
description: Death from cardiac cause
measure: Death from cardiac cause
time frame: 1 year
description: Death from cardiac cause
measure: Death from cardiac cause
time frame: 2 years
description: Death from cardiac cause
measure: Death from cardiac cause
time frame: 3 years
description: Death from cardiac cause
measure: Death from cardiac cause
time frame: 4 years
description: Death from cardiac cause
measure: Death from cardiac cause
time frame: 5 years
description: Death from cardiac cause
measure: Stroke
time frame: 1 month
description: disabling and non-disabling stroke
measure: Stroke
time frame: 1 year
description: disabling and non-disabling stroke
measure: Stroke
time frame: 2 years
description: disabling and non-disabling stroke
measure: Stroke
time frame: 3 years
description: disabling and non-disabling stroke
measure: Stroke
time frame: 4 years
description: disabling and non-disabling stroke
measure: Stroke
time frame: 5 years
description: disabling and non-disabling stroke
measure: Repeat hospitalization
time frame: 1 month
description: Number of hospitalizations
measure: Repeat hospitalization
time frame: 1 year
description: Number of hospitalizations
measure: Repeat hospitalization
time frame: 2 years
description: Number of hospitalizations
measure: Repeat hospitalization
time frame: 3 years
description: Number of hospitalizations
measure: Repeat hospitalization
time frame: 4 years
description: Number of hospitalizations
measure: Repeat hospitalization
time frame: 5 years
description: Number of hospitalizations
measure: Bleeding
time frame: 1 month
description: Life-threatening or major bleeding rate
measure: Bleeding
time frame: 1 year
description: Life-threatening or major bleeding rate
measure: Bleeding
time frame: 2 years
description: Life-threatening or major bleeding rate
measure: Bleeding
time frame: 3 years
description: Life-threatening or major bleeding rate
measure: Bleeding
time frame: 4 years
description: Life-threatening or major bleeding rate
measure: Bleeding
time frame: 5 years
description: Life-threatening or major bleeding rate
measure: Vascular complication
time frame: 1 month
description: Major vascular complication
measure: Vascular complication
time frame: 1 year
description: Major vascular complication
measure: Vascular complication
time frame: 2 years
description: Major vascular complication
measure: Vascular complication
time frame: 3 years
description: Major vascular complication
measure: Vascular complication
time frame: 4 years
description: Major vascular complication
measure: Vascular complication
time frame: 5 years
description: Major vascular complication
measure: Acute kidney injury (stage 2 or 3)
time frame: 1 month
measure: Acute kidney injury (stage 2 or 3)
time frame: 1 year
measure: Acute kidney injury (stage 2 or 3)
time frame: 2 years
measure: Acute kidney injury (stage 2 or 3)
time frame: 3 years
measure: Acute kidney injury (stage 2 or 3)
time frame: 4 years
measure: Acute kidney injury (stage 2 or 3)
time frame: 5 years
measure: Prosthetic regurgitation by Doppler echocardiography
time frame: at discharge
measure: Prosthetic regurgitation by Doppler echocardiography
time frame: 1 month
measure: Prosthetic regurgitation by Doppler echocardiography
time frame: 1 year
measure: Prosthetic regurgitation by Doppler echocardiography
time frame: 2 years
measure: Prosthetic regurgitation by Doppler echocardiography
time frame: 3 years
measure: Prosthetic regurgitation by Doppler echocardiography
time frame: 4 years
measure: Prosthetic regurgitation by Doppler echocardiography
time frame: 5 years
measure: Mean aortic valve gradient by Doppler echocardiography
time frame: 1 month
measure: Mean aortic valve gradient by Doppler echocardiography
time frame: 1 year
measure: Mean aortic valve gradient by Doppler echocardiography
time frame: 2 years
measure: Mean aortic valve gradient by Doppler echocardiography
time frame: 3 years
measure: Mean aortic valve gradient by Doppler echocardiography
time frame: 4 years
measure: Mean aortic valve gradient by Doppler echocardiography
time frame: 5 years
intervention type: Device
intervention name: Transcatheter aortic valve replacement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 129 Years
healthy volunteers: No
last name: Sung-Han Yoon, M.D.
phone: 3104237426
email: Sunghan.Yoon@cshs.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Raj Makkar
investigator title: Profssor of Medicine, University of California
mesh term: Aortic Valve Stenosis
mesh term: Bicuspid Aortic Valve Disease
mesh term: Heart Valve Diseases