<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/NCT04443023</url>
  </required_header>
  <id_info>
    <org_study_id>Compare-TAVI</org_study_id>
    <nct_id>NCT04443023</nct_id>
  </id_info>
  <brief_title>Comparison of Eligible TAVI-valves - Cohort B</brief_title>
  <acronym>Compare-TAVI</acronym>
  <official_title>Randomized Comparison of Eligible TAVI-valves - Cohort B (Sapien Versus Myval)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital Skejby</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aarhus University Hospital Skejby</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>
      The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the present study is to ensure a continuous comparison of the TAVI-valves&#xD;
      implanted, and to monitor long-term valve performances.&#xD;
&#xD;
      Purpose: To randomize between two TAVI-valve types in patients who according to a heart team&#xD;
      conference is found eligible for treatment with more than one valve.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. There is no difference in the combined endpoint (death, stroke, moderate/severe&#xD;
           para-valvular leakage, moderate/severe device stenosis) between the two valves to be&#xD;
           compared.&#xD;
&#xD;
        2. There is no difference between valves in secondary endpoints: death, stroke,&#xD;
           moderate/major paravalvular leakage, moderate/severe aortic device stenosis, new&#xD;
           pacemaker implantation, readmission for congestive heart failure, 6-minute walk test,&#xD;
           and degeneration of the valve as evaluated by computerized tomography (HCT),&#xD;
           transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or MRI.&#xD;
&#xD;
      Design: Randomized controlled trial with clinical national registry follow-up.&#xD;
&#xD;
      Centers eligible for inclusion: Scandinavian and European centers who fulfill the above&#xD;
      mentioned criteria.&#xD;
&#xD;
      Randomization:&#xD;
&#xD;
      Before randomizing patients, the center decides which two valves the patient is found&#xD;
      eligible for, and enters these valves in the electronic randomization form (TrialPartner).&#xD;
      Randomization is then performed between these two valves. A patient is only randomized if a&#xD;
      dedicated technical TAVI conference has found the patient eligible for treatment with both&#xD;
      valves.&#xD;
&#xD;
      Consecutive cohorts are established.&#xD;
&#xD;
      In the current study we plan to initiate the following cohorts:&#xD;
&#xD;
      Cohort B: Patients randomized to the Sapien or the Myval TAVI valve.&#xD;
&#xD;
      Operator requirements:&#xD;
&#xD;
      Any procedure requires that the physician has performed at least 15 implantations with the&#xD;
      valve in use. Otherwise the procedure is performed according to the routine of the&#xD;
      institution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2032</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with MACE (Major Adverse Cardiovascular Events)</measure>
    <time_frame>1 year</time_frame>
    <description>Mortality, stroke, moderate/major PVL, moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with MACE</measure>
    <time_frame>30 day, 3-year, 5-year and 10-year</time_frame>
    <description>Mortality, stroke, moderate/major paravalvular leakage (PVL), moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage death</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year, 10-year</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with stroke</measure>
    <time_frame>During admission, 30-day, 1-year, 3-year, 5-year, 10-year</time_frame>
    <description>According to Valve Academic Research Consortium (VARC)-3 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with moderate or severe paravalvular leakage</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year, 10-year</time_frame>
    <description>Moderate or severe paravalvular leakage according to VARC-3 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with moderate/major aortic stenosis</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year, 10-year</time_frame>
    <description>According to VARC-3 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with new pacemaker</measure>
    <time_frame>During admission, 30-day, 1-year, 3-year, 5-year, 10-year</time_frame>
    <description>New Pacemaker after TAVI-procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with major bleeding</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year, 10-year</time_frame>
    <description>Major bleeding according to Bleeding Academic Research Consortium (BARC) type 3 or 5 criteria, resulting in either a drop in Hbg&gt;=1.86 mmol/l or &gt;=2 units of blood transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance in meters during 6-minute walk test</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year, 10-year</time_frame>
    <description>6-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with other TAVI-related complications</measure>
    <time_frame>During TAVI-procedure</time_frame>
    <description>conversion to open surgery during implantation, unplanned use of cardiopulmonary support (CPS), coronary artery obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, valve thrombosis, valve embolization, valve migration, need for TAVI-in-TAVI deployment, using VARC-3 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with endocarditis</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year, 10-year</time_frame>
    <description>Endocarditis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion with successful implantation of the chosen valve.</measure>
    <time_frame>During procedure</time_frame>
    <description>This means no need for more than 1 TAVI valve, no change to another valve than planned during the procedure because it was impossible to implant the valve planned, and no conversion to surgery or procedure-related death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with major vascular access site and access-related complications</measure>
    <time_frame>During admission and 30-day</time_frame>
    <description>According to VARC-3 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with valve thrombosis or severe stenosis</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year, 10-year</time_frame>
    <description>Valve thrombosis or severe stenosis confirmed by Echo or HCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with readmission with congestive heart failure</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year, 10-year</time_frame>
    <description>Readmission with congestive heart failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with increase in creatinin level of 100% or more, or dialysis</measure>
    <time_frame>during admission and within 30 days</time_frame>
    <description>Increase in renal creatinine level more than to &gt;=200% (AKIN stage 2-3, VARC-3 criteria) or dialysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with moderate/severe PVL stratified according to level of annular calcium on HCT in three groups</measure>
    <time_frame>30-day</time_frame>
    <description>Severity of PVL stratified according to level of annular calcium on HCT (low/medium/high)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Gradient (AO) stratified according to level of annular calcium on HCT in three groups</measure>
    <time_frame>30-day</time_frame>
    <description>Gradient (AO) stratified according to level of annular calcium on HCT (low/medium/high)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with prosthesis-patient mismatch</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year, 10-year</time_frame>
    <description>Prosthesis-patient mismatch (EOA/body surface area). Severe PPM≤0.65 cm2/m2. Moderate PPM≤0.85 cm2/m2 according to VARC-3 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean effective orifice area measured by MRI</measure>
    <time_frame>30-day</time_frame>
    <description>Effective orifice area measured by MRI in patients participating in MRI-substudy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT</measure>
    <time_frame>30-day and 1-year</time_frame>
    <description>Leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT in patients participating in HCT-substudy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean volume of aortic regurgitation measured by MRI</measure>
    <time_frame>30-day</time_frame>
    <description>Volume of aortic regurgitation measured by MRI in patients participating in MRI-substudy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other tavi-related complications</measure>
    <time_frame>30-day</time_frame>
    <description>Anulus rupture or aortic rupture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AMI</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year and 10-year</time_frame>
    <description>Acute Myocardial Infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCI og CABG</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year and 10-year</time_frame>
    <description>Percutaneous Coronary Intervention or coronary artery bypass grafting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reopeation</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year and 10-year</time_frame>
    <description>Reopeation with TAVI, Surgical ortic valve replacement (SAVR) or BAV (Balloon aortic valvuloplasty) according to VARC-3 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Afib</measure>
    <time_frame>30-day, 1-year, 3-year, 5-year and 10-year.</time_frame>
    <description>Newly diagnosed atrial fibrillation according to VARC-3 criteria</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1062</enrollment>
  <condition>Transcatheter Aortic Valve Implantation</condition>
  <arm_group>
    <arm_group_label>Sapien</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Myval</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>chosen TAVI valve</intervention_name>
    <description>chosen TAVI valve</description>
    <arm_group_label>Myval</arm_group_label>
    <arm_group_label>Sapien</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient more than 18 years of age.&#xD;
&#xD;
          2. Patient eligible for at least 2 valves being implanted routinely at the participating&#xD;
             center, according to a TAVI heart team conference.&#xD;
&#xD;
          3. The center experience for each of the valves considered should be more than 15 cases a&#xD;
             year, and at least 15 valves implanted before a valve can be used in the trial.&#xD;
&#xD;
          4. The center volume should be more than 75 cases a year.&#xD;
&#xD;
          5. The patient has given signed informed consent.&#xD;
&#xD;
          6. TAVI performed via the femoral artery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Not able to give written inform consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>henrik nissen, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>odense univeristy hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>christian j terkelsen, Professor</last_name>
    <phone>004587452017</phone>
    <email>chriterk@rm.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>christian juhl J terkelsen</last_name>
      <phone>24288571</phone>
      <email>chriterk@rm.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2022</last_update_submitted>
  <last_update_submitted_qc>July 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital Skejby</investigator_affiliation>
    <investigator_full_name>Christian Juhl Terkelsen</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Normally this will be possible when data are published and anonymized. Mainly to support meta-analysis on individual level data.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>When endpoints are published in an international peer-reviewed paper</ipd_time_frame>
    <ipd_access_criteria>To share data there shall be a well-defined purpose. This could be to contribute to a meta-analysis on individual level data.</ipd_access_criteria>
  </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/NCT04443023
org study id: Compare-TAVI
nct id: NCT04443023
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.
The purpose of the present study is to ensure a continuous comparison of the TAVI-valves
      implanted, and to monitor long-term valve performances.

      Purpose: To randomize between two TAVI-valve types in patients who according to a heart team
      conference is found eligible for treatment with more than one valve.

      Hypotheses:

        1. There is no difference in the combined endpoint (death, stroke, moderate/severe
           para-valvular leakage, moderate/severe device stenosis) between the two valves to be
           compared.

        2. There is no difference between valves in secondary endpoints: death, stroke,
           moderate/major paravalvular leakage, moderate/severe aortic device stenosis, new
           pacemaker implantation, readmission for congestive heart failure, 6-minute walk test,
           and degeneration of the valve as evaluated by computerized tomography (HCT),
           transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or MRI.

      Design: Randomized controlled trial with clinical national registry follow-up.

      Centers eligible for inclusion: Scandinavian and European centers who fulfill the above
      mentioned criteria.

      Randomization:

      Before randomizing patients, the center decides which two valves the patient is found
      eligible for, and enters these valves in the electronic randomization form (TrialPartner).
      Randomization is then performed between these two valves. A patient is only randomized if a
      dedicated technical TAVI conference has found the patient eligible for treatment with both
      valves.

      Consecutive cohorts are established.

      In the current study we plan to initiate the following cohorts:

      Cohort B: Patients randomized to the Sapien or the Myval TAVI valve.

      Operator requirements:

      Any procedure requires that the physician has performed at least 15 implantations with the
      valve in use. Otherwise the procedure is performed according to the routine of the
      institution.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients with MACE (Major Adverse Cardiovascular Events)
time frame: 1 year
description: Mortality, stroke, moderate/major PVL, moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria
measure: Percentage of patients with MACE
time frame: 30 day, 3-year, 5-year and 10-year
description: Mortality, stroke, moderate/major paravalvular leakage (PVL), moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria
measure: Percentage death
time frame: 30-day, 1-year, 3-year, 5-year, 10-year
description: Mortality
measure: Percentage of patients with stroke
time frame: During admission, 30-day, 1-year, 3-year, 5-year, 10-year
description: According to Valve Academic Research Consortium (VARC)-3 criteria
measure: Percentage of patients with moderate or severe paravalvular leakage
time frame: 30-day, 1-year, 3-year, 5-year, 10-year
description: Moderate or severe paravalvular leakage according to VARC-3 criteria
measure: Percentage of patients with moderate/major aortic stenosis
time frame: 30-day, 1-year, 3-year, 5-year, 10-year
description: According to VARC-3 criteria
measure: Percentage of patients with new pacemaker
time frame: During admission, 30-day, 1-year, 3-year, 5-year, 10-year
description: New Pacemaker after TAVI-procedure
measure: Percentage of patients with major bleeding
time frame: 30-day, 1-year, 3-year, 5-year, 10-year
description: Major bleeding according to Bleeding Academic Research Consortium (BARC) type 3 or 5 criteria, resulting in either a drop in Hbg>=1.86 mmol/l or >=2 units of blood transfusion
measure: Distance in meters during 6-minute walk test
time frame: 30-day, 1-year, 3-year, 5-year, 10-year
description: 6-minute walk test
measure: Percentage of patients with other TAVI-related complications
time frame: During TAVI-procedure
description: conversion to open surgery during implantation, unplanned use of cardiopulmonary support (CPS), coronary artery obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, valve thrombosis, valve embolization, valve migration, need for TAVI-in-TAVI deployment, using VARC-3 criteria
measure: Percentage of patients with endocarditis
time frame: 30-day, 1-year, 3-year, 5-year, 10-year
description: Endocarditis
measure: Proportion with successful implantation of the chosen valve.
time frame: During procedure
description: This means no need for more than 1 TAVI valve, no change to another valve than planned during the procedure because it was impossible to implant the valve planned, and no conversion to surgery or procedure-related death.
measure: Percentage of patients with major vascular access site and access-related complications
time frame: During admission and 30-day
description: According to VARC-3 criteria
measure: Percentage of patients with valve thrombosis or severe stenosis
time frame: 30-day, 1-year, 3-year, 5-year, 10-year
description: Valve thrombosis or severe stenosis confirmed by Echo or HCT
measure: Percentage of patients with readmission with congestive heart failure
time frame: 30-day, 1-year, 3-year, 5-year, 10-year
description: Readmission with congestive heart failure
measure: Percentage of patients with increase in creatinin level of 100% or more, or dialysis
time frame: during admission and within 30 days
description: Increase in renal creatinine level more than to >=200% (AKIN stage 2-3, VARC-3 criteria) or dialysis
measure: Percentage of patients with moderate/severe PVL stratified according to level of annular calcium on HCT in three groups
time frame: 30-day
description: Severity of PVL stratified according to level of annular calcium on HCT (low/medium/high)
measure: Mean Gradient (AO) stratified according to level of annular calcium on HCT in three groups
time frame: 30-day
description: Gradient (AO) stratified according to level of annular calcium on HCT (low/medium/high)
measure: Percentage of patients with prosthesis-patient mismatch
time frame: 30-day, 1-year, 3-year, 5-year, 10-year
description: Prosthesis-patient mismatch (EOA/body surface area). Severe PPM≤0.65 cm2/m2. Moderate PPM≤0.85 cm2/m2 according to VARC-3 criteria
measure: Mean effective orifice area measured by MRI
time frame: 30-day
description: Effective orifice area measured by MRI in patients participating in MRI-substudy
measure: Percentage of patients with leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT
time frame: 30-day and 1-year
description: Leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT in patients participating in HCT-substudy
measure: Mean volume of aortic regurgitation measured by MRI
time frame: 30-day
description: Volume of aortic regurgitation measured by MRI in patients participating in MRI-substudy
measure: Other tavi-related complications
time frame: 30-day
description: Anulus rupture or aortic rupture
measure: AMI
time frame: 30-day, 1-year, 3-year, 5-year and 10-year
description: Acute Myocardial Infarction
measure: PCI og CABG
time frame: 30-day, 1-year, 3-year, 5-year and 10-year
description: Percutaneous Coronary Intervention or coronary artery bypass grafting
measure: Reopeation
time frame: 30-day, 1-year, 3-year, 5-year and 10-year
description: Reopeation with TAVI, Surgical ortic valve replacement (SAVR) or BAV (Balloon aortic valvuloplasty) according to VARC-3 criteria
measure: Afib
time frame: 30-day, 1-year, 3-year, 5-year and 10-year.
description: Newly diagnosed atrial fibrillation according to VARC-3 criteria
arm group label: Sapien
arm group type: Active Comparator
description: Patients randomized to treatment
arm group label: Myval
arm group type: Active Comparator
description: Patients randomized to treatment
intervention type: Device
intervention name: chosen TAVI valve
description: chosen TAVI valve
arm group label: Myval
arm group label: Sapien
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: henrik nissen, PhD
role: Study Chair
affiliation: odense univeristy hospital
last name: christian j terkelsen, Professor
phone: 004587452017
email: chriterk@rm.dk
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital Skejby
investigator full name: Christian Juhl Terkelsen
investigator title: Principal investigator
sharing ipd: Yes
ipd description: Normally this will be possible when data are published and anonymized. Mainly to support meta-analysis on individual level data.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: When endpoints are published in an international peer-reviewed paper
ipd access criteria: To share data there shall be a well-defined purpose. This could be to contribute to a meta-analysis on individual level data.