<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/NCT03020043</url>
  </required_header>
  <id_info>
    <org_study_id>FFM CardioMEMS Registry</org_study_id>
    <nct_id>NCT03020043</nct_id>
  </id_info>
  <brief_title>Evaluation of Longterm Outcome of New York Heart Association Class III Heart Failure Patients Receiving Telemonitoring Using a Pulmonary Artery Pressure Sensor System (CardioMEMS)</brief_title>
  <official_title>CardioMEMS Registry of the Frankfurt Heart Failure Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johann Wolfgang Goethe University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johann Wolfgang Goethe University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option.&#xD;
      In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on&#xD;
      mortality and morbidity in a routine clinical setting in Germany, the investigators initiated&#xD;
      this multicenbtric registry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients who receive invasive hemodynamic monitoring using a pulmonary artery pressure&#xD;
      sensor (CardioMEMS device) are offered participation in the registry. Routine heart-failure&#xD;
      parameters, lab values, medication and QoL as obtained on the regular outpatients visits in&#xD;
      the department are entered into a registry-specific database.&#xD;
&#xD;
      The investigators plan to asses the impact of telemonitoring on mortality, morbidity and QoL&#xD;
      as well as on Guideline-recommended heart failure medication. In addition, it is planned to&#xD;
      quantify the input in person time for telemonitoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose</measure>
    <time_frame>5 years</time_frame>
    <description>morbidity</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Chronic Heart Failure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with New York Heart Association (NYHA) Class III with chronic heart failure (left&#xD;
        and right ventricular heart failure, HFrEF, HFmrEF and HFpEF; +/- PH) , who had a&#xD;
        hospitalisation for cardiac decompensation &lt; 12 months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Implantation of CardioMEMS successful&#xD;
&#xD;
          -  Telemonitoring according to the SOP of the Frankfurt Heart Failure Center (Goethe&#xD;
             University)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness to participate in the registry&#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>Birgit Assmus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum Goethe University Frankfurt</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Birgit Assmus, MD</last_name>
    <phone>+49 69 6301</phone>
    <phone_ext>84690</phone_ext>
    <email>birgit.assmus@kgu.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andreas M Zeiher, MD</last_name>
    <phone>+49 69 6301</phone>
    <phone_ext>5789</phone_ext>
    <email>zeiher@em.uni-frankfurt.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Klinikum Goethe University</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Birgit Assmus, MD</last_name>
      <phone>+49 69 6301</phone>
      <phone_ext>84690</phone_ext>
      <email>birgit.assmus@kgu.de</email>
    </contact>
    <contact_backup>
      <last_name>Ester Herrmann, MD</last_name>
      <phone>+49 69 6301</phone>
      <phone_ext>84690</phone_ext>
      <email>ester.herrmann@kgu.de</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University Hospital Justus-Liebe University</name>
      <address>
        <city>Gießen</city>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Birgit Assmus, MD</last_name>
      <phone>+49 641 985</phone>
      <phone_ext>42637</phone_ext>
      <email>birgit.assmus@innere.med.uni-giessen.de</email>
    </contact>
    <contact_backup>
      <last_name>Ardeschir Ghofrani, MD</last_name>
      <phone>+49 641 985</phone>
      <phone_ext>42421</phone_ext>
      <email>Ardeschir.Ghofrani@innere.med.uni-giessen.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Herrmann E, Ecke A, Herrmann E, Eissing N, Fichtlscherer S, Zeiher AM, Assmus B. Daily non-invasive haemodynamic telemonitoring for efficacy evaluation of MitraClip(R) implantation in patients with advanced systolic heart failure. ESC Heart Fail. 2018 Oct;5(5):780-787. doi: 10.1002/ehf2.12303. Epub 2018 Jun 12.</citation>
    <PMID>29893475</PMID>
  </results_reference>
  <results_reference>
    <citation>Herrmann E, Fichtlscherer S, Hohnloser SH, Zeiher AM, Assmus B. [Implantable sensors for outpatient assessment of ventricular filling pressure in advanced heart failure : Which telemonitoring design is optimal?]. Herzschrittmacherther Elektrophysiol. 2016 Dec;27(4):371-377. doi: 10.1007/s00399-016-0472-0. Epub 2016 Nov 14. German.</citation>
    <PMID>27844194</PMID>
  </results_reference>
  <results_reference>
    <citation>Herrmann E, Ecke A, Fichtlscherer S, Zeiher AM, Assmus B. [Pulmonary artery pressure sensor for ambulatory assessment of ventricular filling pressure in advanced heart failure : What should be considered for the follow-up care?]. Herzschrittmacherther Elektrophysiol. 2018 Dec;29(4):393-400. doi: 10.1007/s00399-018-0597-4. Epub 2018 Oct 10. German.</citation>
    <PMID>30306304</PMID>
  </results_reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>September 16, 2019</last_update_submitted>
  <last_update_submitted_qc>September 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johann Wolfgang Goethe University Hospital</investigator_affiliation>
    <investigator_full_name>Birgit Assmus, PD Dr.</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </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/NCT03020043
org study id: FFM CardioMEMS Registry
nct id: NCT03020043
lead sponsor: 
has dmc: No
Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option.
      In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on
      mortality and morbidity in a routine clinical setting in Germany, the investigators initiated
      this multicenbtric registry.
All patients who receive invasive hemodynamic monitoring using a pulmonary artery pressure
      sensor (CardioMEMS device) are offered participation in the registry. Routine heart-failure
      parameters, lab values, medication and QoL as obtained on the regular outpatients visits in
      the department are entered into a registry-specific database.

      The investigators plan to asses the impact of telemonitoring on mortality, morbidity and QoL
      as well as on Guideline-recommended heart failure medication. In addition, it is planned to
      quantify the input in person time for telemonitoring.
observational model: Cohort
time perspective: Prospective
measure: morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose
time frame: 5 years
description: morbidity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Birgit Assmus, MD
role: Principal Investigator
affiliation: Klinikum Goethe University Frankfurt
last name: Birgit Assmus, MD
phone: +49 69 6301
phone ext: 84690
email: birgit.assmus@kgu.de
last name: Andreas M Zeiher, MD
phone: +49 69 6301
phone ext: 5789
email: zeiher@em.uni-frankfurt.de
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
country: Germany
citation: Herrmann E, Ecke A, Herrmann E, Eissing N, Fichtlscherer S, Zeiher AM, Assmus B. Daily non-invasive haemodynamic telemonitoring for efficacy evaluation of MitraClip(R) implantation in patients with advanced systolic heart failure. ESC Heart Fail. 2018 Oct;5(5):780-787. doi: 10.1002/ehf2.12303. Epub 2018 Jun 12.
PMID: 29893475
citation: Herrmann E, Fichtlscherer S, Hohnloser SH, Zeiher AM, Assmus B. [Implantable sensors for outpatient assessment of ventricular filling pressure in advanced heart failure : Which telemonitoring design is optimal?]. Herzschrittmacherther Elektrophysiol. 2016 Dec;27(4):371-377. doi: 10.1007/s00399-016-0472-0. Epub 2016 Nov 14. German.
PMID: 27844194
citation: Herrmann E, Ecke A, Fichtlscherer S, Zeiher AM, Assmus B. [Pulmonary artery pressure sensor for ambulatory assessment of ventricular filling pressure in advanced heart failure : What should be considered for the follow-up care?]. Herzschrittmacherther Elektrophysiol. 2018 Dec;29(4):393-400. doi: 10.1007/s00399-018-0597-4. Epub 2018 Oct 10. German.
PMID: 30306304
responsible party type: Principal Investigator
investigator affiliation: Johann Wolfgang Goethe University Hospital
investigator full name: Birgit Assmus, PD Dr.
investigator title: Prof. Dr. med.
mesh term: Heart Failure
sharing ipd: No