<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/NCT03238937</url>
  </required_header>
  <id_info>
    <org_study_id>00745</org_study_id>
    <nct_id>NCT03238937</nct_id>
  </id_info>
  <brief_title>Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea</brief_title>
  <acronym>STIMULATE-CSA</acronym>
  <official_title>Treatment of Central Sleep Apnea in Patients With Heart Failure With a Cervically Implanted Phrenic Nerve Stimulator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Steward St. Elizabeth's Medical Center of Boston, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Steward St. Elizabeth's Medical Center of Boston, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study objectives are to demonstrate the ease and safety of bilateral cervically implanted&#xD;
      phrenic nerve stimulators for Central Sleep Apnea in patients with Heart Failure. To&#xD;
      demonstrate the efficacy, both in the short and long term, of implanted phrenic nerve&#xD;
      stimulators in patients with Central Sleep Apnea and Heart Failure. Central Sleep Apnea is a&#xD;
      form of hypoventilation syndrome, for which this device is FDA approved. We will also&#xD;
      determine if the patient's quality and duration of life is improved by using the PNS to treat&#xD;
      CSA in heart failure patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center prospective cohort study to monitor the effect of bilateral phrenic&#xD;
      nerve stimulation for treatment of central sleep apnea (CSA) in patients with heart failure.&#xD;
      There will be 2 groups of study patients, both with CSA and heart failure. One group will&#xD;
      receive the phrenic nerve pacer, and one will not. Both groups will have the same medical&#xD;
      oversight, management, and assessment of heart health whether they receive the pacer or not.&#xD;
&#xD;
      Subjects will have a physical exam, review of medications, New York Heart Association (NYHA)&#xD;
      functional classification assessment for heart failure, Minnesota Living With Heart Failure&#xD;
      (MLWHF) Questionnaire for quality of live assessment and blood test for Pro-BNP. In-lab sleep&#xD;
      study will be required if subject haven't had one within 3 months, and Echocardiogram, if&#xD;
      subjects haven't had one within 30 days. If subjects are willing to have stimulator placement&#xD;
      procedure, they'll have an ENT consult. Subjects in the procedure arm will have Phrenic Nerve&#xD;
      Stimulator placement procedure, and 3 weeks after procedure follow up visit with ENT doctor&#xD;
      to activate the device and have sleep study to confirm proper settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No eligible subjects were identified.&#xD;
  </why_stopped>
  <start_date type="Actual">October 5, 2017</start_date>
  <completion_date type="Actual">April 29, 2019</completion_date>
  <primary_completion_date type="Actual">April 29, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with treatment related adverse events as assessed by CTCAEv40</measure>
    <time_frame>2 years</time_frame>
    <description>Visual Analog Score for pain, BMI in Kg/m ^2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in quality of life with phrenic nerve stimulation in patients with central sleep apnea and heart failure</measure>
    <time_frame>2 years</time_frame>
    <description>Physicians Global Assessments to measure quality of life,</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Sleep Apnea, Central</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Phrenic Nerve Stimulator</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Phrenic Nerve Stimlator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients without phrenic nerve stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phrenic nerve stimulator</intervention_name>
    <description>Implantation of phrenic nerve stimulator</description>
    <arm_group_label>Phrenic Nerve Stimulator</arm_group_label>
    <other_name>no intervention / medical management only</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Male or female, age 18 to 80 years inclusive.&#xD;
&#xD;
             2. New York Heart Association (NYHA) class III or IV, or NYHA class II with an episode&#xD;
             of heart failure requiring hospitalization in the past 24 months.&#xD;
&#xD;
             3. Stable on guide line directed medical therapy (GDMT) for 30 days prior to&#xD;
             enrollment.&#xD;
&#xD;
             4. Moderate or severe sleep apnea, that is an Apnea Hypopnea Index (AHI) of &gt;15/hour&#xD;
             with &gt;50% being central apneas.&#xD;
&#xD;
             5. Willing and able to provide written informed consent in compliance with the&#xD;
             regulatory requirements. If a subject is unable to provide written informed consent,&#xD;
             written informed consent may be obtained from the subject's legal representative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Phrenic nerve palsy.&#xD;
&#xD;
          2. Baseline hypoxia (oxygen saturation &lt;90% on room air).&#xD;
&#xD;
          3. On supplemental oxygen.&#xD;
&#xD;
          4. Severe COPD.&#xD;
&#xD;
          5. Unstable angina, MI or cardiac procedure within 3 months of phrenic nerve stimulator&#xD;
             placement.&#xD;
&#xD;
          6. Unwilling or unable to comply with the requirements of this protocol, including the&#xD;
             presence of any condition (physical, mental, or social) that is likely to affect the&#xD;
             subject's ability to comply with the protocol.&#xD;
&#xD;
          7. Any other reasons that, in the opinion of the Investigator, the candidate is&#xD;
             determined to be unsuitable for entry into the study.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lana Tsao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Steward St. Elizabeth's Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SEMC</name>
      <address>
        <city>Brighton</city>
        <state>Massachusetts</state>
        <zip>02135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Steward St. Elizabeth's Medical Center of Boston, Inc.</investigator_affiliation>
    <investigator_full_name>Lana Tsao</investigator_full_name>
    <investigator_title>Cardiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Central</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Will share protocol and study results</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>once the protocol is approved and as data becomes available indefinitively</ipd_time_frame>
    <ipd_access_criteria>via secure website</ipd_access_criteria>
  </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/NCT03238937
org study id: 00745
nct id: NCT03238937
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The study objectives are to demonstrate the ease and safety of bilateral cervically implanted
      phrenic nerve stimulators for Central Sleep Apnea in patients with Heart Failure. To
      demonstrate the efficacy, both in the short and long term, of implanted phrenic nerve
      stimulators in patients with Central Sleep Apnea and Heart Failure. Central Sleep Apnea is a
      form of hypoventilation syndrome, for which this device is FDA approved. We will also
      determine if the patient's quality and duration of life is improved by using the PNS to treat
      CSA in heart failure patients.
This is a multi-center prospective cohort study to monitor the effect of bilateral phrenic
      nerve stimulation for treatment of central sleep apnea (CSA) in patients with heart failure.
      There will be 2 groups of study patients, both with CSA and heart failure. One group will
      receive the phrenic nerve pacer, and one will not. Both groups will have the same medical
      oversight, management, and assessment of heart health whether they receive the pacer or not.

      Subjects will have a physical exam, review of medications, New York Heart Association (NYHA)
      functional classification assessment for heart failure, Minnesota Living With Heart Failure
      (MLWHF) Questionnaire for quality of live assessment and blood test for Pro-BNP. In-lab sleep
      study will be required if subject haven't had one within 3 months, and Echocardiogram, if
      subjects haven't had one within 30 days. If subjects are willing to have stimulator placement
      procedure, they'll have an ENT consult. Subjects in the procedure arm will have Phrenic Nerve
      Stimulator placement procedure, and 3 weeks after procedure follow up visit with ENT doctor
      to activate the device and have sleep study to confirm proper settings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with treatment related adverse events as assessed by CTCAEv40
time frame: 2 years
description: Visual Analog Score for pain, BMI in Kg/m ^2
measure: Improvement in quality of life with phrenic nerve stimulation in patients with central sleep apnea and heart failure
time frame: 2 years
description: Physicians Global Assessments to measure quality of life,
arm group label: Phrenic Nerve Stimulator
arm group type: Other
description: Phrenic Nerve Stimlator
arm group label: no intervention
arm group type: No Intervention
description: Patients without phrenic nerve stimulation
intervention type: Device
intervention name: Phrenic nerve stimulator
description: Implantation of phrenic nerve stimulator
arm group label: Phrenic Nerve Stimulator
other name: no intervention / medical management only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lana Tsao, MD
role: Principal Investigator
affiliation: Steward St. Elizabeth's Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.
investigator full name: Lana Tsao
investigator title: Cardiologist
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Central
mesh term: Heart Failure
sharing ipd: Yes
ipd description: Will share protocol and study results
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: once the protocol is approved and as data becomes available indefinitively
ipd access criteria: via secure website