<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/NCT03032211</url>
  </required_header>
  <id_info>
    <org_study_id>2016-CHF-003</org_study_id>
    <nct_id>NCT03032211</nct_id>
  </id_info>
  <brief_title>Optimal Balance Alfapump® System Feasibility Study</brief_title>
  <acronym>OPTIMALBALANCE</acronym>
  <official_title>A Feasibility Clinical Study of Osmotic Pump Treatment in Fluid Management to Achieve Optimal Fluid Balance in NYHA Class III and Ambulatory NYHA Class IV Heart Failure Patients Who Have an Estimated Glomerular Filtration Rate of &gt; 15 to &lt; 60 mL/Min/1.73m2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sequana Medical N.V.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sequana Medical N.V.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Summary of Clinical Investigation&#xD;
&#xD;
      A summary of the clinical investigation is provided below and includes the primary objective&#xD;
      of the study, the safety and feasibility endpoints, the number of subjects to be enrolled,&#xD;
      the study duration, the subject follow-up and the inclusion/exclusion criteria.&#xD;
&#xD;
        1. Primary Objective&#xD;
&#xD;
           The primary objective of the study is to evaluate the safety and feasibility of the&#xD;
           alfapump® System indication for use in the management of fluid in NYHA Class III and&#xD;
           ambulatory NYHA Class IV heart failure patients who have an eGFR of &gt; 15 to &lt; 60&#xD;
           mL/min/1.73m2.&#xD;
&#xD;
        2. Study Endpoints&#xD;
&#xD;
             1. Primary Safety Endpoint&#xD;
&#xD;
                The primary safety endpoint will be an assessment of the occurrence of adverse&#xD;
                events (AEs) and serious adverse events (SAEs) related to:&#xD;
&#xD;
                  1. Surgical implant of the alfapump®&#xD;
&#xD;
                  2. Device malfunctions&#xD;
&#xD;
                  3. Dialysate infusion&#xD;
&#xD;
             2. Secondary Safety Endpoints&#xD;
&#xD;
                The secondary endpoint will be an assessment of:&#xD;
&#xD;
                  1. Time to first hospitalization related to fluid management after the activation&#xD;
                     of the alfapump® System and initiation of dialysate infusion has occurred&#xD;
&#xD;
                  2. Rate of occurrence of re-hospitalizations related to fluid management&#xD;
&#xD;
                  3. All-cause mortality&#xD;
&#xD;
             3. Assessment of Feasibility for Fluid Management in Heart Failure Indication The&#xD;
                feasibility of the alfapump® System for management of fluid in NYHA Class III and&#xD;
                ambulatory NYHA Class IV heart failure patients with renal dysfunction will be&#xD;
                assessed by the net fluid balance as measured by the ability of the alfapump®&#xD;
                System to move more fluid to the bladder than dialysate instilled.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Change in company strategy&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 31, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Phase 1</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>• Prospective, non-randomized, open label, single-arm study to evaluate the safety and feasibility of the use of the alfapump® system in New York Heart Association (NYHA) Class III and ambulatory NYHA Class IV heart failure patients with a history of at least one hospitalization for fluid management within the previous year.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of adverse events (AEs) and serious adverse events (SAEs)</measure>
    <time_frame>Q1 2017 and Q3 2017</time_frame>
    <description>4 weeks after the third patient implanted an initial safety review will be done and after the last patient completed 3 months of dialysate administration.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alfapump</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alfapump</intervention_name>
    <description>Implant Alfapump® System</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Males or females ≥ 18 years and &lt; 80 years of age&#xD;
&#xD;
          -  Patients exhibiting physical signs of excessive fluid retention (i.e. elevated JVD,&#xD;
             peripheral edema, ascites, pulmonary edema, weight gain etc.)&#xD;
&#xD;
          -  Patients with an eGFR by the Modification of Diet in Renal Disease (MDRD) of &gt; 15 to &lt;&#xD;
             60 mL/min/1.73m2&#xD;
&#xD;
          -  Patients with a brain natriuretic peptide (BNP) ≥ 150 pg/mL and/or N-terminal&#xD;
             prohormone of brain natriuretic peptide (NT-proBNP) ≥ 600 pg/mL at time of screening&#xD;
             or BNP ≥ 100 pg/mL and/or NTproBNP ≥ 400 pg/mL&#xD;
&#xD;
          -  Patients who have a Six Minute Walk Test (SMWT) exercise capacity between 100 and 400&#xD;
             meters&#xD;
&#xD;
          -  Patients presenting with NYHA Class III or ambulatory NYHA Class IV heart failure who&#xD;
             have been on optimal medical management (OMM) based on current heart failure practice&#xD;
             guidelines and who are failing to respond to or cannot tolerate one or more of the&#xD;
             following interventions:&#xD;
&#xD;
               1. Treatment with diuretic therapy&#xD;
&#xD;
               2. Treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin&#xD;
                  receptor blockers (ARBs) for at least 30 days&#xD;
&#xD;
               3. Treatment with nitrates and/or vasodilators at the investigator's discretion&#xD;
&#xD;
               4. Treatment with beta-blockers for at least 90 days&#xD;
&#xD;
               5. Treatment with cardiac resynchronization therapy (CRT)&#xD;
&#xD;
               6. Treatment with an automatic implantable cardioverter defibrillator (AICD)&#xD;
&#xD;
          -  Patients who demonstrate compliance with the current medical regimen as reported by&#xD;
             the treating physician&#xD;
&#xD;
        Enrollment Exclusion Criteria&#xD;
&#xD;
          -  Patients presenting with acute decompensated heart failure requiring hospitalization&#xD;
             for management of their symptoms (i.e. hospitalization for exacerbation of chronic&#xD;
             heart failure manifested by signs and symptoms requiring intravenous and/or more&#xD;
             aggressive therapy)&#xD;
&#xD;
          -  Patients with ascites on physical examination resulting predominantly from right heart&#xD;
             failure&#xD;
&#xD;
          -  Patients who have an indication for and are candidates for CRT but who have not been&#xD;
             treated with CRT&#xD;
&#xD;
          -  Patients who have an indication for and are candidates for an AICD but who have not&#xD;
             been implanted with an AICD&#xD;
&#xD;
          -  Patients with reversible causes of heart failure which may be remedied by conventional&#xD;
             surgery or other interventions&#xD;
&#xD;
          -  Patients with an eGFR by MDRD &lt; 15 or &gt; 60 ml/min/1.73m2&#xD;
&#xD;
          -  Patients with a body mass index (BMI) &lt; 18 kg/m2or &gt; 35 kg/m2&#xD;
&#xD;
          -  Patients with severe pulmonary disease by history (i.e. severe chronic obstructive&#xD;
             pulmonary disease, severe hypoxia or a pulmonary artery mean pressure &gt;40 mm Hg)&#xD;
&#xD;
          -  Patients who have experienced a myocardial infarction (MI) within the past 90 days&#xD;
&#xD;
          -  Patients who have experienced a cerebrovascular accident (CVA) or transient ischemic&#xD;
             attack (TIA) within the past 90 days&#xD;
&#xD;
          -  Patients who have undergone cardiac surgery or other major surgery within the past 90&#xD;
             days&#xD;
&#xD;
          -  Patients who are candidates for and require a concomitant surgical procedure [i.e.&#xD;
             coronary artery bypass graft (CABG), valvular surgery, etc.&#xD;
&#xD;
          -  Patients who are candidates for and require temporary or durable mechanical&#xD;
             circulatory support [i.e. intra-aortic balloon pump (IABP), ventricular assist device&#xD;
             (VAD), extracorporeal membrane oxygenation (ECMO)]&#xD;
&#xD;
          -  Patients with confirmed untreated abdominal aortic aneurysm (AAA) &gt; 5 cm in diameter&#xD;
             diagnosed within the past six months&#xD;
&#xD;
          -  Patients with active systemic or uncontrolled infections&#xD;
&#xD;
          -  Patients who are pregnant (Note: Negative pregnancy test will be required in all women&#xD;
             - Patients with known alcohol or illicit drug abuse or dependence within the previous&#xD;
             three months&#xD;
&#xD;
          -  Patients who are currently enrolled or who have participated in the past 30 days in&#xD;
             another therapeutic and/or interventional clinical study&#xD;
&#xD;
          -  Patients with technical obstacles that pose an inordinately high surgical risk in the&#xD;
             judgment of the Investigator&#xD;
&#xD;
          -  Patients who have any underlying condition that, in the opinion of the Investigator,&#xD;
             would disqualify the patient for inclusion in the study, limit survival to less than&#xD;
             one year, or not permit valid consideration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Military Hospital - State Health Centre</name>
      <address>
        <city>Budapest</city>
        <zip>1134</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>March 18, 2021</last_update_submitted>
  <last_update_submitted_qc>March 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Study cancelled, therefore not applicable at time of answering this remark.</ipd_description>
  </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/NCT03032211
org study id: 2016-CHF-003
nct id: NCT03032211
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
1. Summary of Clinical Investigation

      A summary of the clinical investigation is provided below and includes the primary objective
      of the study, the safety and feasibility endpoints, the number of subjects to be enrolled,
      the study duration, the subject follow-up and the inclusion/exclusion criteria.

        1. Primary Objective

           The primary objective of the study is to evaluate the safety and feasibility of the
           alfapump® System indication for use in the management of fluid in NYHA Class III and
           ambulatory NYHA Class IV heart failure patients who have an eGFR of > 15 to < 60
           mL/min/1.73m2.

        2. Study Endpoints

             1. Primary Safety Endpoint

                The primary safety endpoint will be an assessment of the occurrence of adverse
                events (AEs) and serious adverse events (SAEs) related to:

                  1. Surgical implant of the alfapump®

                  2. Device malfunctions

                  3. Dialysate infusion

             2. Secondary Safety Endpoints

                The secondary endpoint will be an assessment of:

                  1. Time to first hospitalization related to fluid management after the activation
                     of the alfapump® System and initiation of dialysate infusion has occurred

                  2. Rate of occurrence of re-hospitalizations related to fluid management

                  3. All-cause mortality

             3. Assessment of Feasibility for Fluid Management in Heart Failure Indication The
                feasibility of the alfapump® System for management of fluid in NYHA Class III and
                ambulatory NYHA Class IV heart failure patients with renal dysfunction will be
                assessed by the net fluid balance as measured by the ability of the alfapump®
                System to move more fluid to the bladder than dialysate instilled.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: • Prospective, non-randomized, open label, single-arm study to evaluate the safety and feasibility of the use of the alfapump® system in New York Heart Association (NYHA) Class III and ambulatory NYHA Class IV heart failure patients with a history of at least one hospitalization for fluid management within the previous year.
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of adverse events (AEs) and serious adverse events (SAEs)
time frame: Q1 2017 and Q3 2017
description: 4 weeks after the third patient implanted an initial safety review will be done and after the last patient completed 3 months of dialysate administration.
arm group label: Treatment
arm group type: Experimental
description: Alfapump
intervention type: Device
intervention name: Alfapump
description: Implant Alfapump® System
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Hungary
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: Undecided
ipd description: Study cancelled, therefore not applicable at time of answering this remark.