<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/NCT02252757</url>
  </required_header>
  <id_info>
    <org_study_id>AV.CO.v0-01</org_study_id>
    <nct_id>NCT02252757</nct_id>
  </id_info>
  <brief_title>Assess Measurements of Wireless Cardiac Output Device</brief_title>
  <acronym>Remote-CO-1</acronym>
  <official_title>Validation of Measurements From CoVa Sensor (VALIDATION-CO-1) Study to Assess Measurements of Wireless Cardiac Output Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aventyn, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>BMS Hospital Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Intel Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Aventyn, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heart failure is a common cardiovascular problem which is increasing in both prevalence and&#xD;
      incidence and associated with substantial morbidity and mortality. The management of heart&#xD;
      failure patients is complex and has become a priority world over. Effective methods to keep&#xD;
      heart failure patients out of the hospital are essential, both in the interests of the&#xD;
      patient's health, as well as to reduce the burden on the health care system&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart failure patients should be in a position to provide readings of their weight, blood&#xD;
      pressure, fluid intake, thoracic fluid, heart rate, heart rate variability, respiration rate,&#xD;
      stroke volume, cardiac output, medications and other important parameters and communicate&#xD;
      this data to care providers using wireless technology. This data should be made available to&#xD;
      medical personnel regularly and on a periodic basis. In this manner the health care providers&#xD;
      can detect and respond to warning signs or alerts before the patient's condition worsens to&#xD;
      warrant a visit to the doctor or a hospital admission with features of heart failure&#xD;
      decompensation. Programs for chronic heart failure that include remote monitoring have been&#xD;
      shown to have a positive effect on clinical outcomes in community dwelling patients with&#xD;
      chronic heart failure.&#xD;
&#xD;
      In preparation for a study evaluating the effectiveness of mobile monitoring, the value of&#xD;
      Stroke Volume and Cardiac Output need to be validated against FDA approved devices that are&#xD;
      available in a hospital or clinic setting. This study covers the validation of the&#xD;
      measurements taken with the proposed home monitoring device, Perminova's CoVaTM Sensor&#xD;
      (Sensor) against clinic devices such as bio-impedance devices, echocardiogram, Doppler and/or&#xD;
      MRI&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measuring Cardiac Output for wireless transmission as per discharge guideline</measure>
    <time_frame>2 Weeks</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Congestive Heart Failure</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CoVa</intervention_name>
    <other_name>Vitalbeat Remote Disease Managment</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study is targeted towards at-risk heart failure patients. An &quot;at-risk&quot; patient is&#xD;
        defined as a patient who has risk factors for Heart Failure as described in the table below&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects of either gender above the age of 18 years&#xD;
&#xD;
          -  The subject is able and willing to provide written informed consent prior to&#xD;
             enrollment in the study&#xD;
&#xD;
          -  One or more of the following diagnosis&#xD;
&#xD;
          -  New York Heart Association (NYHA) classification class of I-IV or Stages A-D&#xD;
&#xD;
          -  Symptoms of dyspnea&#xD;
&#xD;
          -  Chronic renal failure on renal replacement therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who may not come for follow up or likely to drop out of the study&#xD;
&#xD;
          -  Any illness which may preclude regular follow up&#xD;
&#xD;
          -  Patient is unable or not willing to wear electrode patches as required&#xD;
&#xD;
          -  Patient has skin sensitivity to adhesive or hydrogel materials used in electrode&#xD;
             patches&#xD;
&#xD;
          -  Patient is considered by the PI to be medically unsuitable for study participation&#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>Kris Vijay, MD, MS, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scottsdale Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scottsdale Cardiovascular Center</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.gov/show/NCT01430936</url>
    <description>Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices (REMOTE-HF-1)</description>
  </link>
  <reference>
    <citation>Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. doi: 10.1136/bmj.39156.536968.55. Epub 2007 Apr 10.</citation>
    <PMID>17426062</PMID>
  </reference>
  <reference>
    <citation>Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2.</citation>
    <PMID>20687083</PMID>
  </reference>
  <results_reference>
    <citation>Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. doi: 10.1161/CIRCULATIONAHA.105.167586. Epub 2005 Sep 13. No abstract available.</citation>
    <PMID>16160202</PMID>
  </results_reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mHealth, hypertension, atherosclerotic disease, diabetes, obesity, metabolic syndrome, cardiotoxins, cardiomyopathy, dsypnea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_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/NCT02252757
org study id: AV.CO.v0-01
nct id: NCT02252757
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Heart failure is a common cardiovascular problem which is increasing in both prevalence and
      incidence and associated with substantial morbidity and mortality. The management of heart
      failure patients is complex and has become a priority world over. Effective methods to keep
      heart failure patients out of the hospital are essential, both in the interests of the
      patient's health, as well as to reduce the burden on the health care system
Heart failure patients should be in a position to provide readings of their weight, blood
      pressure, fluid intake, thoracic fluid, heart rate, heart rate variability, respiration rate,
      stroke volume, cardiac output, medications and other important parameters and communicate
      this data to care providers using wireless technology. This data should be made available to
      medical personnel regularly and on a periodic basis. In this manner the health care providers
      can detect and respond to warning signs or alerts before the patient's condition worsens to
      warrant a visit to the doctor or a hospital admission with features of heart failure
      decompensation. Programs for chronic heart failure that include remote monitoring have been
      shown to have a positive effect on clinical outcomes in community dwelling patients with
      chronic heart failure.

      In preparation for a study evaluating the effectiveness of mobile monitoring, the value of
      Stroke Volume and Cardiac Output need to be validated against FDA approved devices that are
      available in a hospital or clinic setting. This study covers the validation of the
      measurements taken with the proposed home monitoring device, Perminova's CoVaTM Sensor
      (Sensor) against clinic devices such as bio-impedance devices, echocardiogram, Doppler and/or
      MRI
observational model: Cohort
time perspective: Prospective
measure: Measuring Cardiac Output for wireless transmission as per discharge guideline
time frame: 2 Weeks
intervention type: Device
intervention name: CoVa
other name: Vitalbeat Remote Disease Managment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kris Vijay, MD, MS, FACC
role: Principal Investigator
affiliation: Scottsdale Healthcare
facility: 
country: United States
url: http://clinicaltrials.gov/show/NCT01430936
description: Evaluate Heart Failure Patients With Specially Designed Patient Adherence and Monitoring Software on Standard Mobile Devices (REMOTE-HF-1)
citation: Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. doi: 10.1136/bmj.39156.536968.55. Epub 2007 Apr 10.
PMID: 17426062
citation: Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2.
PMID: 20687083
citation: Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. doi: 10.1161/CIRCULATIONAHA.105.167586. Epub 2005 Sep 13. No abstract available.
PMID: 16160202
responsible party type: Sponsor
mesh term: Heart Failure