<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/NCT03775161</url>
  </required_header>
  <id_info>
    <org_study_id>CLC-0001</org_study_id>
    <nct_id>NCT03775161</nct_id>
  </id_info>
  <brief_title>V-LAP™ Left Atrium Monitoring systEm for Patients With Chronic sysTOlic &amp; Diastolic Congestive heaRt Failure</brief_title>
  <acronym>VECTOR-HF</acronym>
  <official_title>A First in Human Multi-center, Open Label, Prospective Study to Evaluate the Safety, Usability and Performance of the V-LAP™ System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vectorious Medical Technologies Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Horizon 2020 - European Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vectorious Medical Technologies Ltd.</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 the trial is to evaluate the safety, usability and performance of the V-LAP™&#xD;
      System in adult subjects with New York Heart Association (NYHA) Class III Heart Failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial is designed to demonstrate that the V-LAP™ implant can be positioned in the&#xD;
      interatrial septum, and that Sensor pressure measurements correlate to standardized methods&#xD;
      of intra-cardiac pressure measurements post-sensor implant and at the 3 month follow up&#xD;
      visit. Safety will be monitored by the occurrence of adverse events throughout the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usability of the Delivery System</measure>
    <time_frame>Intraoperative (Implantation)</time_frame>
    <description>Ability to successfully deliver (to the interatrial septum) and deploy the V-LAPIM using the V-LAPDL and acutely perform initial pressure measurement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety Endpoint: Study (Device and/ or system) related Major Adverse Cardiac and Neurological Events (MACNE)</measure>
    <time_frame>Up to three months post-procedure</time_frame>
    <description>(as defined in the protocol), as by the independent Clinical Events Committee</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance communication</measure>
    <time_frame>Up to three months post-procedure</time_frame>
    <description>Freedom from failure of the V-LAP system to obtain the left atrial pressure (LAP) measurement from the sensory implant and transmit the LAP data to the V-LAP Data Display</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance accuracy</measure>
    <time_frame>At index (baseline) and at three months</time_frame>
    <description>LAP accuracy validation, concordance of the V-LAP implant measurement with pulmonary capillary wedge pressure (PCWP) measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability Assessment</measure>
    <time_frame>Up to 24 months post procedure</time_frame>
    <description>Usability Assessment of the V-LAP system will be measured by questionnaires that will be completed by the investigator, patient and medical team.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>NYHA functional class</measure>
    <time_frame>Up to 24 months post procedure</time_frame>
    <description>Change in NYHA functional class ranking during the study compare to baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>KCCQ score</measure>
    <time_frame>Up to 24 months post procedure</time_frame>
    <description>Change in KCCQ score at 6, 12 and 24 months vs. baseline.</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart failure hospitalization rate</measure>
    <time_frame>Up to 60 months post procedure</time_frame>
    <description>Heart failure hospitalization rate at 6, 12, 24, 36, 48, and 60 months (rate is calculated as the number of hospitalizations over individual patient follow-up duration).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>V-LAP™ System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Percutaneous implantation of the V-LAP™ implant by right heart catheterization (RHC) approach and daily LAP measurements at home</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>V-LAP™ System</intervention_name>
    <description>Delivery of the V-LAP™ implant via a catheter-based approach in a trans-septal puncture procedure, deploying it in the inter-atrial septum.</description>
    <arm_group_label>V-LAP™ System</arm_group_label>
    <other_name>Echocardiography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ischemic or non-ischemic cardiomyopathy and documented heart failure for at least 6&#xD;
             months.&#xD;
&#xD;
          2. ACC/AHA Stage C, NYHA Class III or ambulatory Class IV HF documented at Baseline&#xD;
             Visit.&#xD;
&#xD;
          3. Receiving maximally tolerated medical therapy for heart failure as indicated per&#xD;
             ACC/AHA or ESC Heart Failure Guidelines (guideline-directed medical therapy or GDMT),&#xD;
             such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin&#xD;
             receptor blocker (ARB), beta-blocker (BB), and mineralocorticoid receptor blocker&#xD;
             (MRB) for at least 3 months prior to the Baseline visit.&#xD;
&#xD;
          4. Receiving rhythm management device therapy as recommended by the ACC/AHA or ESC&#xD;
             Guidelines. Specifically: cardiac resynchronization therapy (CRT) should be implanted&#xD;
             for at least 90 days prior to enrollment; an implanted cardioverter-defibrillator&#xD;
             (ICD) or a pacemaker should be implanted at least 30 days prior to enrollment. If&#xD;
             subject is clinically contraindicated for these therapies this criterion may be&#xD;
             waived.&#xD;
&#xD;
          5. Have a minimum of one (1) prior hospital admission within the last 12-months for acute&#xD;
             worsening of HF associated with signs/symptoms of congestion of at least one (1)&#xD;
             calendar date change duration requiring treatment with an intravenous diuretic. If CRT&#xD;
             device previously implanted, the heart failure hospitalization must be ≥ 30 days after&#xD;
             CRT implantation. Alternatively, if patients have not had a HF hospitalization within&#xD;
             the prior 12-months, they must have a corrected* elevated Brain Natriuretic Peptide&#xD;
             (BNP) level of at least 300pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at&#xD;
             least 1,500pg/ml, according to local measurement, within 30-days of the Baseline&#xD;
             Visit. *Thresholds for NT-proBNP will be corrected for body mass index (BMI) using a&#xD;
             4% reduction per BMI unit over 20 kg/m2, If patient is on ARNI, NT-proBNP should be&#xD;
             used exclusively.&#xD;
&#xD;
          6. Provide informed consent for study participation and be willing and able to comply&#xD;
             with the required tests, treatment instructions and follow-up visits.&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt;18 or &gt;85 years old.&#xD;
&#xD;
          2. Patients who are NYHA class IV not ambulatory and ACC stage D.&#xD;
&#xD;
          3. Patients with evidence/history of an intra-cardiac thrombus or history of stroke,&#xD;
             transient ischemic attack, systemic or pulmonary thromboembolism, deep vein thrombosis&#xD;
             (DVT), within the last 6 months.&#xD;
&#xD;
          4. Patients with a resting systolic blood pressure &lt;90 or &gt;180 mmHg and/ or Severe&#xD;
             pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg on&#xD;
             screening baseline echocardiogram.&#xD;
&#xD;
          5. Left ventricular end-diastolic diameter (LVEDD) &gt; 8cm.&#xD;
&#xD;
          6. Have an atrial septal defect or patent foramen ovale with more than trace shunting on&#xD;
             color Doppler or intravenous bubble study or surgical or interventional correction of&#xD;
             congenital heart disease involving atrial septum including placement of a PFO or ASD&#xD;
             closure device and have a hypermobile septum or a septal aneurysm&#xD;
&#xD;
          7. Patients with untreated severe valve lesions, which are indicated for surgical or&#xD;
             percutaneous intervention, severe regurgitant (grade 4+) valve lesions, active&#xD;
             valvular vegetations, atrial myxoma, hypertrophic cardiomyopathy with significant&#xD;
             resting or provoked subaortic gradient, acute myocarditis, tamponade, or large&#xD;
             pericardial effusion, constrictive pericarditis, infiltrative cardiomyopathy&#xD;
             (including cardiac sarcoidosis, amyloidosis, and hemochromatosis), or congenital heart&#xD;
             disease, as cause of HF.&#xD;
&#xD;
          8. Uncontrolled tachyarrhythmia or bradycardia (heart rate &lt;45).&#xD;
&#xD;
          9. Intractable HF with resting symptoms despite maximal medical therapy (ACC/AHA HF Stage&#xD;
             D), including patients receiving continuous or intermittent outpatient IV vasoactive&#xD;
             medications (e.g., IV inotropes, IV vasodilators), patients treated with a ventricular&#xD;
             assist device (VAD).&#xD;
&#xD;
         10. Intolerant to diuretics, ACEI and ARB and beta-blocker medical therapy for patients&#xD;
             classified as HFrEF (EF ≤40%).&#xD;
&#xD;
         11. The presence of an acute coronary syndrome (ACS), percutaneous coronary intervention&#xD;
             (PCI), rhythm management system revision, lead extraction, or cardiac or other major&#xD;
             surgery within the preceding 90 days.&#xD;
&#xD;
         12. Patients not eligible for emergency open-heart, thoracic or vascular surgery.&#xD;
&#xD;
         13. Women of childbearing age&#xD;
&#xD;
         14. Patients with a life expectancy that is shorter than 12 months, or those who have&#xD;
             received a cardiac transplant or are listed for cardiac transplantation and likely to&#xD;
             be transplanted within 12 months.&#xD;
&#xD;
         15. Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for&#xD;
             all of the forms of antiplatelet/anticoagulant treatments anticipated in the protocol&#xD;
&#xD;
         16. Have an estimated glomerular filtration rate &lt;25 ml/min/1.73 m2 by the MDRD method or&#xD;
             on dialysis.&#xD;
&#xD;
         17. Hepatic impairment with at least one liver Function Test (transaminases, total&#xD;
             bilirubin, or alkaline phosphatase) ≥ 3 times upper limit of normal.&#xD;
&#xD;
         18. Gastrointestinal bleeding in the last 6 months&#xD;
&#xD;
         19. Have severe chronic pulmonary disease requiring continuous home oxygen, chronic oral&#xD;
             steroid therapy, hospitalization for exacerbation during prior 6 months, or has severe&#xD;
             obstructive physiology on PFTs (FEV1/FVC &lt;0.70 and FEV1 &lt; 50% normal).&#xD;
&#xD;
         20. Patients who have an active infection requiring systemic antibiotics or an elevated&#xD;
             white blood count (above the local laboratory reference ranges)&#xD;
&#xD;
         21. Have a history of active drug addiction, active alcohol abuse, or psychiatric hospital&#xD;
             admission for psychosis within the prior 2 years.&#xD;
&#xD;
         22. Are currently participating in a clinical investigation that includes an active&#xD;
             treatment arm.&#xD;
&#xD;
         23. Subject otherwise not appropriate for study as determined by the investigator. The&#xD;
             reasons must be documented.&#xD;
&#xD;
         24. Patients contraindicated for trans-septal puncture, TEE or ICE.&#xD;
&#xD;
             Intra Procedural Exclusion Criteria:&#xD;
&#xD;
             (Intra Procedural Exclusion Criteria will be determined immediately after intracardiac&#xD;
             echocardiography or transesophageal echocardiography determination of left atrial&#xD;
             anatomy and just before trans-septal puncture)&#xD;
&#xD;
         25. Anatomical anomaly on TEE or ICE that precludes implantation of the V-LAPIM across the&#xD;
             interatrial septum (Fossa Ovalis) including: Septal thickness at fossa &gt; 5 mm, FO&#xD;
             Dimension &lt;16mm, ASD or PFO with more than a trace amount of shunting, Intra- cardiac&#xD;
             thrombus felt to be acute and not present on prior exams and Abnormal septum, e.g. a&#xD;
             hypermobile septum or a septal aneurysm.&#xD;
&#xD;
         26. Inadequate vascular access for implantation of V-LAPIM or are unable to tolerate an&#xD;
             RHC.&#xD;
&#xD;
         27. Hemodynamic at time of Index Procedure including: Severe pulmonary hypertension&#xD;
             defined as PASP&gt;70 mmHg or PVR &gt;4.0 Woods Units (mmHg L-1 min-1); Resting systolic&#xD;
             Blood Pressure &lt;90 or &gt;180 mmHg, not corrected with IV fluid administration or&#xD;
             vasodilators, respectively.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Horst Sievert, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director and Founder of CardioVasculäres Centrum Frankfurt</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlo Di Mario, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florence and Careggi University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francisco Leyva, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Cardiologist, Queen Elizabeth Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CardioVasculäres Centrum Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60389</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Careggi University Hospital Trust</name>
      <address>
        <city>Florence</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
  </location_countries>
  <removed_countries>
    <country>Israel</country>
  </removed_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</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>No</sharing_ipd>
  </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/NCT03775161
org study id: CLC-0001
nct id: NCT03775161
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the trial is to evaluate the safety, usability and performance of the V-LAP™
      System in adult subjects with New York Heart Association (NYHA) Class III Heart Failure.
The trial is designed to demonstrate that the V-LAP™ implant can be positioned in the
      interatrial septum, and that Sensor pressure measurements correlate to standardized methods
      of intra-cardiac pressure measurements post-sensor implant and at the 3 month follow up
      visit. Safety will be monitored by the occurrence of adverse events throughout the trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Usability of the Delivery System
time frame: Intraoperative (Implantation)
description: Ability to successfully deliver (to the interatrial septum) and deploy the V-LAPIM using the V-LAPDL and acutely perform initial pressure measurement.
measure: Safety Endpoint: Study (Device and/ or system) related Major Adverse Cardiac and Neurological Events (MACNE)
time frame: Up to three months post-procedure
description: (as defined in the protocol), as by the independent Clinical Events Committee
measure: Performance communication
time frame: Up to three months post-procedure
description: Freedom from failure of the V-LAP system to obtain the left atrial pressure (LAP) measurement from the sensory implant and transmit the LAP data to the V-LAP Data Display
measure: Performance accuracy
time frame: At index (baseline) and at three months
description: LAP accuracy validation, concordance of the V-LAP implant measurement with pulmonary capillary wedge pressure (PCWP) measurement
measure: Usability Assessment
time frame: Up to 24 months post procedure
description: Usability Assessment of the V-LAP system will be measured by questionnaires that will be completed by the investigator, patient and medical team.
measure: NYHA functional class
time frame: Up to 24 months post procedure
description: Change in NYHA functional class ranking during the study compare to baseline
measure: KCCQ score
time frame: Up to 24 months post procedure
description: Change in KCCQ score at 6, 12 and 24 months vs. baseline.
measure: Heart failure hospitalization rate
time frame: Up to 60 months post procedure
description: Heart failure hospitalization rate at 6, 12, 24, 36, 48, and 60 months (rate is calculated as the number of hospitalizations over individual patient follow-up duration).
arm group label: V-LAP™ System
arm group type: Experimental
description: Percutaneous implantation of the V-LAP™ implant by right heart catheterization (RHC) approach and daily LAP measurements at home
intervention type: Device
intervention name: V-LAP™ System
description: Delivery of the V-LAP™ implant via a catheter-based approach in a trans-septal puncture procedure, deploying it in the inter-atrial septum.
arm group label: V-LAP™ System
other name: Echocardiography
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Horst Sievert, Prof. Dr.
role: Principal Investigator
affiliation: Director and Founder of CardioVasculäres Centrum Frankfurt
last name: Carlo Di Mario, Professor
role: Principal Investigator
affiliation: University of Florence and Careggi University Hospital
last name: Francisco Leyva, Professor
role: Principal Investigator
affiliation: Consultant Cardiologist, Queen Elizabeth Hospital
facility: 
facility: 
country: Germany
country: Italy
country: Israel
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No