<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/NCT03781258</url>
  </required_header>
  <id_info>
    <org_study_id>Version 1.0</org_study_id>
    <nct_id>NCT03781258</nct_id>
  </id_info>
  <brief_title>Anti-thrombotic Monotherapy in HeartMate 3 Left Ventricular Assist System (LVAS)</brief_title>
  <official_title>Safety and Feasibility of Transition to Anti-thrombotic Monotherapy With the HeartMate 3 LVAS: A Multicenter Prospective Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute for Clinical and Experimental Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute for Clinical and Experimental Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this prospective controlled study is to obtain a multi-center safety and&#xD;
      feasibility data on patients managed with anti-thrombotic monotherapy with HeartMate 3 LVAS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients implanted with the HeartMate 3 LVAS will be screened for participation in the study&#xD;
      with established stability at 6 months after implantation of the device. If inclusion&#xD;
      criteria are met, patients will be transitioned to a single anti-thrombotic therapy with&#xD;
      Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with&#xD;
      warfarin will be withdrawn. ASA will be administered in a minimum dose of 100 mg per day with&#xD;
      dosage adjustments based on VerifyNow testing up to a maximum of 200 mg daily. The primary&#xD;
      endpoints will be analyzed at 90 and 180 days after initiation of the single antiplatelet&#xD;
      therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">November 23, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients implanted with the HeartMate 3 LVAS will be screened for participation in the study with established stability at 6 months after implantation of the device. If inclusion criteria are met, patients will be transitioned to a single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) or equivalent and anticoagulation with warfarin will be withdrawn. ASA will be administered in a minimum dose of 100 mg per day with dosage adjustments based on VerifyNow testing up to a maximum of 200 mg daily. The primary endpoint will be analyzed at 90 and 180 days after initiation of the single antiplatelet therapy.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival free of a pump malfunction due to thrombosis or any ischemic stroke</measure>
    <time_frame>180 days</time_frame>
    <description>To determine survival free of a pump malfunction due to thrombosis or any ischemic stroke at 90-days (primary safety end point) and at 180-days (primary efficacy end point) in patients implanted with HeartMate 3 LVAS after transition to a single antithrombotic with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>180 days</time_frame>
    <description>Adverse events rates per Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definitions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Heart Failure</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Anit-thrombotic monotherapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with HeartMate 3 LVAS transitioning from Warfarin and Acetylsalicylic Acid (ASA) therapy to receive anti-thrombotic monotherapy (ASA).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin</intervention_name>
    <description>Anti-thrombotic monotherapy (ASA)-Warfarin withdrawal.</description>
    <arm_group_label>Anit-thrombotic monotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients implanted with HeartMate 3 LVAS irrespective of intended goal of treatment of&#xD;
             bridge to transplant or destination therapy&#xD;
&#xD;
          -  a minimum of 6 months since HeartMate3 LVAS implantation free of thromboembolic events&#xD;
             and pump malfunction&#xD;
&#xD;
          -  evidence of forward flow across the aortic valve (with aortic valve opening of at&#xD;
             least 1:2 per cardiac cycle) at baseline echocardiography (ECHO) or after speed&#xD;
             reduction as long as no evidence of progression of heart failure is noted, based on a&#xD;
             combination of biomarkers and clinical assessment follow-up (see Appendix III);&#xD;
             Clinical assessment will include review of the biomarkers, invasive or non-invasive&#xD;
             hemodynamics (as available or indicated) and clinical physical examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  absence of an informed consent&#xD;
&#xD;
          -  presence of any prosthetic valve or central aortic valve repair (e.g. Park's stitch)&#xD;
&#xD;
          -  presence of any other ancillary circulatory assist device system&#xD;
&#xD;
          -  known history of major thrombotic event e.g. deep vein thrombosis (DVT)&#xD;
&#xD;
          -  known history of stroke&#xD;
&#xD;
          -  left atrial appendage in patients with atrial fibrillation or flutter not addressed by&#xD;
             resection or exclusion at a time of the implant&#xD;
&#xD;
          -  evidence of any intracardiac thrombus evidenced by transoesophageal echocardiography&#xD;
&#xD;
          -  any other clinical indication for a use of long-term anticoagulation using a vitamin K&#xD;
             antagonist or thrombin inhibitor (e.g. specified known genetic thrombotic mutation&#xD;
             mandating the therapy, malignancy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute for Clinical and Experimental Medicine</name>
      <address>
        <city>Prague</city>
        <state>Prague 4</state>
        <zip>14021</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <link>
    <url>http://doi.org/10.1016/j.healun.2018.03.002</url>
    <description>Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the Minimal AnticoaGulation EvaluatioN To aUgment heMocompatibility (MAGENTUM) 1 study</description>
  </link>
  <reference>
    <citation>Mehra MR, Goldstein DJ, Uriel N, Cleveland JC Jr, Yuzefpolskaya M, Salerno C, Walsh MN, Milano CA, Patel CB, Ewald GA, Itoh A, Dean D, Krishnamoorthy A, Cotts WG, Tatooles AJ, Jorde UP, Bruckner BA, Estep JD, Jeevanandam V, Sayer G, Horstmanshof D, Long JW, Gulati S, Skipper ER, O'Connell JB, Heatley G, Sood P, Naka Y; MOMENTUM 3 Investigators. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018 Apr 12;378(15):1386-1395. doi: 10.1056/NEJMoa1800866. Epub 2018 Mar 11.</citation>
    <PMID>29526139</PMID>
  </reference>
  <reference>
    <citation>Netuka I, Ivak P, Tucanova Z, Gregor S, Szarszoi O, Sood P, Crandall D, Rimsans J, Connors JM, Mehra MR. Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study. J Heart Lung Transplant. 2018 May;37(5):579-586. doi: 10.1016/j.healun.2018.03.002. Epub 2018 Apr 11.</citation>
    <PMID>29655662</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>August 1, 2020</last_update_submitted>
  <last_update_submitted_qc>August 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute for Clinical and Experimental Medicine</investigator_affiliation>
    <investigator_full_name>Prof. Ivan Netuka, MD, Ph.D.</investigator_full_name>
    <investigator_title>Chairman of the Department of Cardiovascular Surgery</investigator_title>
  </responsible_party>
  <keyword>Mechanical circulatory support</keyword>
  <keyword>Anti-thrombotic monotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Warfarin</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/NCT03781258
org study id: Version 1.0
nct id: NCT03781258
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this prospective controlled study is to obtain a multi-center safety and
      feasibility data on patients managed with anti-thrombotic monotherapy with HeartMate 3 LVAS.
Patients implanted with the HeartMate 3 LVAS will be screened for participation in the study
      with established stability at 6 months after implantation of the device. If inclusion
      criteria are met, patients will be transitioned to a single anti-thrombotic therapy with
      Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy and anticoagulation with
      warfarin will be withdrawn. ASA will be administered in a minimum dose of 100 mg per day with
      dosage adjustments based on VerifyNow testing up to a maximum of 200 mg daily. The primary
      endpoints will be analyzed at 90 and 180 days after initiation of the single antiplatelet
      therapy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients implanted with the HeartMate 3 LVAS will be screened for participation in the study with established stability at 6 months after implantation of the device. If inclusion criteria are met, patients will be transitioned to a single anti-thrombotic therapy with Acetylsalicylic Acid (ASA) or equivalent and anticoagulation with warfarin will be withdrawn. ASA will be administered in a minimum dose of 100 mg per day with dosage adjustments based on VerifyNow testing up to a maximum of 200 mg daily. The primary endpoint will be analyzed at 90 and 180 days after initiation of the single antiplatelet therapy.
primary purpose: Other
masking: None (Open Label)
measure: Survival free of a pump malfunction due to thrombosis or any ischemic stroke
time frame: 180 days
description: To determine survival free of a pump malfunction due to thrombosis or any ischemic stroke at 90-days (primary safety end point) and at 180-days (primary efficacy end point) in patients implanted with HeartMate 3 LVAS after transition to a single antithrombotic with Acetylsalicylic Acid (ASA) or equivalent antiplatelet therapy.
measure: Adverse Events
time frame: 180 days
description: Adverse events rates per Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definitions.
arm group label: Anit-thrombotic monotherapy
arm group type: Other
description: Patients with HeartMate 3 LVAS transitioning from Warfarin and Acetylsalicylic Acid (ASA) therapy to receive anti-thrombotic monotherapy (ASA).
intervention type: Drug
intervention name: Warfarin
description: Anti-thrombotic monotherapy (ASA)-Warfarin withdrawal.
arm group label: Anit-thrombotic monotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Czechia
url: http://doi.org/10.1016/j.healun.2018.03.002
description: Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the Minimal AnticoaGulation EvaluatioN To aUgment heMocompatibility (MAGENTUM) 1 study
citation: Mehra MR, Goldstein DJ, Uriel N, Cleveland JC Jr, Yuzefpolskaya M, Salerno C, Walsh MN, Milano CA, Patel CB, Ewald GA, Itoh A, Dean D, Krishnamoorthy A, Cotts WG, Tatooles AJ, Jorde UP, Bruckner BA, Estep JD, Jeevanandam V, Sayer G, Horstmanshof D, Long JW, Gulati S, Skipper ER, O'Connell JB, Heatley G, Sood P, Naka Y; MOMENTUM 3 Investigators. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018 Apr 12;378(15):1386-1395. doi: 10.1056/NEJMoa1800866. Epub 2018 Mar 11.
PMID: 29526139
citation: Netuka I, Ivak P, Tucanova Z, Gregor S, Szarszoi O, Sood P, Crandall D, Rimsans J, Connors JM, Mehra MR. Evaluation of low-intensity anti-coagulation with a fully magnetically levitated centrifugal-flow circulatory pump-the MAGENTUM 1 study. J Heart Lung Transplant. 2018 May;37(5):579-586. doi: 10.1016/j.healun.2018.03.002. Epub 2018 Apr 11.
PMID: 29655662
responsible party type: Principal Investigator
investigator affiliation: Institute for Clinical and Experimental Medicine
investigator full name: Prof. Ivan Netuka, MD, Ph.D.
investigator title: Chairman of the Department of Cardiovascular Surgery
mesh term: Cardiovascular Diseases
mesh term: Warfarin