<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/NCT04437303</url>
  </required_header>
  <id_info>
    <org_study_id>NL73805.100.20</org_study_id>
    <nct_id>NCT04437303</nct_id>
  </id_info>
  <brief_title>Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)</brief_title>
  <official_title>Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Antonius Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Antonius Hospital</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>
      Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for&#xD;
      patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an&#xD;
      incidence of around 4-5% in the first 30 days. Up to 50% of patients undergoing TAVI have an&#xD;
      indication for oral anticoagulants (OAC) mostly for atrial fibrillation. OAC use during TAVI&#xD;
      could increase bleeding complications, but interruption during TAVI may increase the risk for&#xD;
      thromboembolic events (i.e. stroke, systemic embolism, myocardial infarction). Recent&#xD;
      observational data suggest that periprocedural continuation of OAC is safe and might decrease&#xD;
      the risk of stroke. Beside the potential reduction of thromboembolic events, continuation of&#xD;
      OAC is associated with an evident clinical ancillary benefit for patients and staff. Since&#xD;
      periprocedural OAC interruption not infrequently leads to misunderstanding and potentially&#xD;
      dangerous situations, when patients are not properly informed before hospital admission or&#xD;
      may experience difficulties with the interruption regimen.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic&#xD;
      complications without an increase in bleeding complications at 30 days&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 25, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Net clinical benefit</measure>
    <time_frame>30 days</time_frame>
    <description>A composite of cardiovascular mortality, stroke, myocardial infarction, major vascular complications and major, disabling and life-threatening bleeding complications at 30 days post TAVI as defined by the VARC-2 criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thromboembolic complications</measure>
    <time_frame>30 days</time_frame>
    <description>Composite of stroke, transient ischemic attack, systemic embolism, distal embolization, myocardial infarction, and cardiovascular death not caused by bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding and vascular access site complications</measure>
    <time_frame>30 days</time_frame>
    <description>Composite of bleeding and vascular access site and access-related complications (except distal embolization and systemic embolism)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early safety as defined by Valve Academic Research Consortium 2 criteria</measure>
    <time_frame>30 days</time_frame>
    <description>Composite of all-cause mortality, all stroke, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring repeat procedure (balloon valvuloplasty or valve replacement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy as defined by Valve Academic Research Consortium 2 criteria</measure>
    <time_frame>30 days</time_frame>
    <description>Composite of all-cause mortality, all stroke, hospitalizations for valve related symptoms or worsening congestive heart failure, New York Heart Association class for heart failure 3/4, and valve-related dysfunction (mean aortic valve gradient &gt;=20 mmHg, effective orifice area (EOA) &lt;=0.9-1.1 cm^2 and/or Doppler velocity index (DVI) &lt;0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by Short Form-12 Questionnaire</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by Toronto Aortic Stenosis Questionnaire</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by Kansas City Cardiomyopathy Questionnaire</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke and transient ischemic attack</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Bleeding classification as defined by the International Society of Thrombosis and Haemostasis criteria</measure>
    <time_frame>30 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Bleeding classification as defined by Thrombolysis In Myocardial Infarction criteria</measure>
    <time_frame>30 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Bleeding classification as defined by Bleeding Academic Research Consortium criteria</measure>
    <time_frame>30 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Primary endpoints at discharge</measure>
    <time_frame>Discharge</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>New York Heart Association class for heart failure</measure>
    <time_frame>30 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Device success as defined by Valve Academic Research Consortium 2 criteria</measure>
    <time_frame>30 days</time_frame>
    <description>Absence or procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical position AND 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 prosthetic valve regurgitation)</description>
  </other_outcome>
  <other_outcome>
    <measure>Time-related valve safety as defined by Valve Academic Research Consortium 2 criteria</measure>
    <time_frame>30 days</time_frame>
    <description>Composite of:&#xD;
Structural valve deterioration&#xD;
(valve-related dysfunction (mean aortic valve gradient &gt;=20 mmHg, effective orifice area (EOA) &lt;=0.9-1.1 cm^2 and/or Doppler velocity index (DVI) &lt;0.35 m/s, and/or moderate or severe prosthetic valve regurgitation)&#xD;
(requiring repeat procedure)&#xD;
Prosthetic valve endocarditis&#xD;
Prosthetic valve thrombosis&#xD;
Thrombo-embolic events (e.g. stroke)&#xD;
Bleeding (as defined by Valve Academic Research Consortium), unless clearly unrelated to valve therapy (e.g. trauma)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">858</enrollment>
  <condition>Aortic Valve Disease</condition>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Stroke</condition>
  <condition>Bleeding</condition>
  <condition>Vascular Complications</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Thrombosis Embolism</condition>
  <arm_group>
    <arm_group_label>Continuation of oral anticoagulants</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Interruption of oral anticoagulants</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Continuation of oral anticoagulants</intervention_name>
    <description>Oral anticoagulant treatment will not be interrupted before the procedure.</description>
    <arm_group_label>Continuation of oral anticoagulants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Interruption of oral anticoagulants</intervention_name>
    <description>Peri-operative interruption of oral anticoagulants will be according to the Dutch guideline on antithrombotic therapy.&#xD;
For direct oral anticoagulant users this will be in general 48 hours before the procedure, except for Dabigatran users with renal insufficiency: with estimated glomerular filtration rate 50-80 mL/min/1.73m^2 72 hours and with estimated glomerular filtration rate 30-50 mL/min/1.73m^2 96 hours before procedure.&#xD;
For vitamin K antagonist users this will be 5 days for phenprocoumon and 3 days for acenocoumarol.&#xD;
After the procedure oral anticoagulants will be resumed after 24 hours, if deemed safe by the treating physician.</description>
    <arm_group_label>Interruption of oral anticoagulants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Planned transfemoral or transsubclavian transcatheter aortic valve implantation&#xD;
             procedure&#xD;
&#xD;
          -  Uses oral anticoagulation at screening&#xD;
&#xD;
          -  Provided written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients at high risk for thromboembolism for whom interruption of oral anticoagulants is&#xD;
        no option, i.e.:&#xD;
&#xD;
          -  Mechanical heart valve prosthesis&#xD;
&#xD;
          -  Intracardiac thrombus&#xD;
&#xD;
          -  &lt; 3 months after venous thromboembolism&#xD;
&#xD;
          -  &lt; 6 months after transient ischemic attack or stroke in patients with atrial&#xD;
             fibrillation&#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>Jurriën M ten Berg, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Antonius Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dirk-Jan van Ginkel, MD</last_name>
    <phone>+31 (0)88 320 66 48</phone>
    <email>d.van.ginkel@antoniusziekenhuis.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wilbert Bor, MD</last_name>
    <phone>+31 (0)88 320 12 41</phone>
    <email>w.bor@antoniusziekenhuis.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>A.S.Z. Hospital</name>
      <address>
        <city>Aalst</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>L. Rosseel, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>O.L.V. Hospital</name>
      <address>
        <city>Aalst</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>E. Barbato, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>ZNA Middelheim</name>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>P. Agostoni, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Jan</name>
      <address>
        <city>Brugge</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>J. van der Heyden, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>East Limburg Hospital</name>
      <address>
        <city>Genk</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>B. Ferdinande, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. C. Dubois, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. O. Debacker, MD, PhD</last_name>
    </contact>
    <contact_backup>
      <last_name>Prof. L. Søndergaard, MD, PhD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>National Institute of Cardiac Surgery and Interventional Cardiology</name>
      <address>
        <city>Luxembourg</city>
        <country>Luxembourg</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>P. Frambach, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <state>Utrecht</state>
        <zip>3435CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dirk-Jan van Ginkel, MD</last_name>
      <email>d.van.ginkel@antoniusziekenhuis.nl</email>
    </contact>
    <investigator>
      <last_name>Vincent Nijenhuis, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jorn Brouwer, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wilbert Bor, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>R. Delewi, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Amphia Hospital</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>S. IJsselmuiden, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>UMC Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>J.J. Wykrzykowska, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>F. van der Kley, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Maastricht UMC+</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>L. Veenstra, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Radboud UMC</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. N. van Royen, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. N.M.D.A. van Mieghem, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Haga Hospital</name>
      <address>
        <city>The Hague</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>C. Schotborgh, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>UMC Utrecht</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>M. Voskuil, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Isala</name>
      <address>
        <city>Zwolle</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>R. Hermanides, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>Luxembourg</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Antonius Hospital</investigator_affiliation>
    <investigator_full_name>Jurriën M. ten Berg, MD, PhD</investigator_full_name>
    <investigator_title>Professor dr.</investigator_title>
  </responsible_party>
  <keyword>Transcatheter Aortic Valve Implantation (TAVI)</keyword>
  <keyword>Transcatheter Aortic Valve Replacement (TAVR)</keyword>
  <keyword>Aortic Valve Disease</keyword>
  <keyword>Aortic Valve Stenosis</keyword>
  <keyword>Stroke</keyword>
  <keyword>Bleeding</keyword>
  <keyword>Vascular Complications</keyword>
  <keyword>Myocardial Infarction</keyword>
  <keyword>Thrombosis Embolism</keyword>
  <keyword>Heart Diseases</keyword>
  <keyword>Oral Anticoagulation</keyword>
  <keyword>Warfarin</keyword>
  <keyword>Vitamin K Antagonist</keyword>
  <keyword>Direct Acting Oral Anticoagulants</keyword>
  <keyword>Protamine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Aortic Valve Disease</mesh_term>
    <mesh_term>Embolism and Thrombosis</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anticoagulants</mesh_term>
  </intervention_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/NCT04437303
org study id: NL73805.100.20
nct id: NCT04437303
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for
      patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an
      incidence of around 4-5% in the first 30 days. Up to 50% of patients undergoing TAVI have an
      indication for oral anticoagulants (OAC) mostly for atrial fibrillation. OAC use during TAVI
      could increase bleeding complications, but interruption during TAVI may increase the risk for
      thromboembolic events (i.e. stroke, systemic embolism, myocardial infarction). Recent
      observational data suggest that periprocedural continuation of OAC is safe and might decrease
      the risk of stroke. Beside the potential reduction of thromboembolic events, continuation of
      OAC is associated with an evident clinical ancillary benefit for patients and staff. Since
      periprocedural OAC interruption not infrequently leads to misunderstanding and potentially
      dangerous situations, when patients are not properly informed before hospital admission or
      may experience difficulties with the interruption regimen.

      Hypothesis:

      Periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic
      complications without an increase in bleeding complications at 30 days
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Net clinical benefit
time frame: 30 days
description: A composite of cardiovascular mortality, stroke, myocardial infarction, major vascular complications and major, disabling and life-threatening bleeding complications at 30 days post TAVI as defined by the VARC-2 criteria.
measure: Thromboembolic complications
time frame: 30 days
description: Composite of stroke, transient ischemic attack, systemic embolism, distal embolization, myocardial infarction, and cardiovascular death not caused by bleeding
measure: Bleeding and vascular access site complications
time frame: 30 days
description: Composite of bleeding and vascular access site and access-related complications (except distal embolization and systemic embolism)
measure: Early safety as defined by Valve Academic Research Consortium 2 criteria
time frame: 30 days
description: Composite of all-cause mortality, all stroke, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring repeat procedure (balloon valvuloplasty or valve replacement)
measure: Clinical efficacy as defined by Valve Academic Research Consortium 2 criteria
time frame: 30 days
description: Composite of all-cause mortality, all stroke, hospitalizations for valve related symptoms or worsening congestive heart failure, New York Heart Association class for heart failure 3/4, and valve-related dysfunction (mean aortic valve gradient >=20 mmHg, effective orifice area (EOA) <=0.9-1.1 cm^2 and/or Doppler velocity index (DVI) <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
measure: All-cause death
time frame: 30 days
measure: Quality of life assessed by Short Form-12 Questionnaire
time frame: 3 months
measure: Quality of life assessed by Toronto Aortic Stenosis Questionnaire
time frame: 3 months
measure: Quality of life assessed by Kansas City Cardiomyopathy Questionnaire
time frame: 3 months
measure: Stroke
time frame: 30 days
measure: Stroke and transient ischemic attack
time frame: 30 days
measure: Bleeding classification as defined by the International Society of Thrombosis and Haemostasis criteria
time frame: 30 days
measure: Bleeding classification as defined by Thrombolysis In Myocardial Infarction criteria
time frame: 30 days
measure: Bleeding classification as defined by Bleeding Academic Research Consortium criteria
time frame: 30 days
measure: Primary endpoints at discharge
time frame: Discharge
measure: New York Heart Association class for heart failure
time frame: 30 days
measure: Device success as defined by Valve Academic Research Consortium 2 criteria
time frame: 30 days
description: Absence or procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical position AND 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 prosthetic valve regurgitation)
measure: Time-related valve safety as defined by Valve Academic Research Consortium 2 criteria
time frame: 30 days
description: Composite of:
Structural valve deterioration
(valve-related dysfunction (mean aortic valve gradient >=20 mmHg, effective orifice area (EOA) <=0.9-1.1 cm^2 and/or Doppler velocity index (DVI) <0.35 m/s, and/or moderate or severe prosthetic valve regurgitation)
(requiring repeat procedure)
Prosthetic valve endocarditis
Prosthetic valve thrombosis
Thrombo-embolic events (e.g. stroke)
Bleeding (as defined by Valve Academic Research Consortium), unless clearly unrelated to valve therapy (e.g. trauma)
arm group label: Continuation of oral anticoagulants
arm group type: Active Comparator
arm group label: Interruption of oral anticoagulants
arm group type: Active Comparator
intervention type: Drug
intervention name: Continuation of oral anticoagulants
description: Oral anticoagulant treatment will not be interrupted before the procedure.
arm group label: Continuation of oral anticoagulants
intervention type: Drug
intervention name: Interruption of oral anticoagulants
description: Peri-operative interruption of oral anticoagulants will be according to the Dutch guideline on antithrombotic therapy.
For direct oral anticoagulant users this will be in general 48 hours before the procedure, except for Dabigatran users with renal insufficiency: with estimated glomerular filtration rate 50-80 mL/min/1.73m^2 72 hours and with estimated glomerular filtration rate 30-50 mL/min/1.73m^2 96 hours before procedure.
For vitamin K antagonist users this will be 5 days for phenprocoumon and 3 days for acenocoumarol.
After the procedure oral anticoagulants will be resumed after 24 hours, if deemed safe by the treating physician.
arm group label: Interruption of oral anticoagulants
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jurriën M ten Berg, MD PhD
role: Principal Investigator
affiliation: St. Antonius Hospital
last name: Dirk-Jan van Ginkel, MD
phone: +31 (0)88 320 66 48
email: d.van.ginkel@antoniusziekenhuis.nl
last name: Wilbert Bor, MD
phone: +31 (0)88 320 12 41
email: w.bor@antoniusziekenhuis.nl
facility: 
status: Recruiting
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country: Belgium
country: Denmark
country: Luxembourg
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: St. Antonius Hospital
investigator full name: Jurriën M. ten Berg, MD, PhD
investigator title: Professor dr.
mesh term: Myocardial Infarction
mesh term: Thrombosis
mesh term: Embolism
mesh term: Aortic Valve Stenosis
mesh term: Aortic Valve Disease
mesh term: Embolism and Thrombosis
mesh term: Infarction
mesh term: Hemorrhage
mesh term: Anticoagulants