<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/NCT03293381</url>
  </required_header>
  <id_info>
    <org_study_id>826102</org_study_id>
    <nct_id>NCT03293381</nct_id>
  </id_info>
  <brief_title>Electrogram-Guided Myocardial Advanced Phenotyping</brief_title>
  <acronym>eMAP</acronym>
  <official_title>Electrogram-Guided Myocardial Advanced Phenotyping (The eMAP Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biosense Webster, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for&#xD;
      biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-Ischemic Cardiomyopathy (NICM) is a common cause of heart failure (HF) and death. NICM is&#xD;
      a heterogeneous entity, and specific etiologies are infrequently identified. In part due to&#xD;
      limited disease characterization, specific treatments are lacking for most of the different&#xD;
      underlying causes of NICM. Depending on the cohort, 30-70 percent of patients with new-onset&#xD;
      NICM develop persistent systolic dysfunction despite guideline-directed medical therapy, and&#xD;
      these patients have high rates of subsequent morbidity and resource utilization.&#xD;
&#xD;
      Current guidelines support the use of endomyocardial biopsy (EMB) in patients with both&#xD;
      new-onset and persistent cardiomyopathy. However, EMB is underutilized in these populations&#xD;
      due to its low diagnostic yield. A combination of sampling error resulting from standard&#xD;
      fluoroscopy-guided EMB in disease entities with patchy myocardial involvement and rudimentary&#xD;
      tissue phenotyping of the specimens which are obtained contribute to this low diagnostic&#xD;
      yield. In recent years, there has been increasing interest in the use of electro-anatomic&#xD;
      mapping (EAM) to help identify areas of myocardium with discrete pathology based on&#xD;
      abnormalities in intra-cardiac electrogram voltage and morphologies. Therefore, the primary&#xD;
      objective of this protocol is to provide definitive evidence that EAM-guided biopsy leads to&#xD;
      a superior diagnostic yield compared with conventional fluoroscopy-guided biopsy in patients&#xD;
      with new-onset and persistent NICM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Anticipated">November 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2023</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>Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.</measure>
    <time_frame>November 2018</time_frame>
    <description>Additional biopsies</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Non-ischemic Cardiomyopathy</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>additional biopsies</intervention_name>
    <description>additional biopsies</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with New onset NICM that are scheduled for a biopsy as part of their clinical care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. New onset NICM as defined by the presence of left ventricular dysfunction (LVEF &lt; 45%&#xD;
             by echocardiography and/or MRI), with symptoms or signs of HF (dyspnea, orthopnea,&#xD;
             edema, ascites, rales or pulmonary vascular congestion on chest radiography) of less&#xD;
             than 3 months in duration.&#xD;
&#xD;
          3. Persistent recent onset NICM as defined by the LVEF and signs/symptoms in #2 above&#xD;
             with persistence of the LVEF &lt; 45% despite evidence-based treatment for HF with&#xD;
             reduced LVEF for 2 to 6 months.&#xD;
&#xD;
          4. Willingness to provide informed consent&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior diagnosis of HF or documented LVEF &lt; 45% more than 6 months prior to enrollment.&#xD;
&#xD;
          2. Coronary artery disease, either by history or as determined by coronary angiography&#xD;
             demonstrating hemodynamically significant lesions deemed sufficient to potentially&#xD;
             contribute to left ventricular dysfunction.&#xD;
&#xD;
          3. Ongoing hemodynamically significant arrhythmias deemed to be an independent cause of&#xD;
             HF decompensation&#xD;
&#xD;
          4. Constrictive pericarditis or tamponade&#xD;
&#xD;
          5. Complex congenital heart disease&#xD;
&#xD;
          6. History of malignancy with treatment by anthracyclines or other known cardiotoxic&#xD;
             chemotherapeutic agents&#xD;
&#xD;
          7. More than mild aortic or mitral stenosis&#xD;
&#xD;
          8. Intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid&#xD;
             regurgitation&#xD;
&#xD;
          9. Primary hypertrophic cardiomyopathy&#xD;
&#xD;
         10. Untreated thyroid disease&#xD;
&#xD;
         11. Severe nutritional deficiency&#xD;
&#xD;
         12. Severe uncontrolled hypertension&#xD;
&#xD;
         13. Sepsis, active infection (excluding cystitis) or other comorbidity driving the HF&#xD;
             decompensation&#xD;
&#xD;
         14. History of cardiac transplantation&#xD;
&#xD;
         15. Acute or chronic severe liver disease as evidenced by any of the following:&#xD;
             encephalopathy, variceal bleeding, INR &gt; 1.5 in the absence of anticoagulation&#xD;
             treatment&#xD;
&#xD;
         16. Inability to comply with planned study procedures&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francis Marchlinski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 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>Cardiomyopathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03293381
org study id: 826102
nct id: NCT03293381
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for
      biopsy.
Non-Ischemic Cardiomyopathy (NICM) is a common cause of heart failure (HF) and death. NICM is
      a heterogeneous entity, and specific etiologies are infrequently identified. In part due to
      limited disease characterization, specific treatments are lacking for most of the different
      underlying causes of NICM. Depending on the cohort, 30-70 percent of patients with new-onset
      NICM develop persistent systolic dysfunction despite guideline-directed medical therapy, and
      these patients have high rates of subsequent morbidity and resource utilization.

      Current guidelines support the use of endomyocardial biopsy (EMB) in patients with both
      new-onset and persistent cardiomyopathy. However, EMB is underutilized in these populations
      due to its low diagnostic yield. A combination of sampling error resulting from standard
      fluoroscopy-guided EMB in disease entities with patchy myocardial involvement and rudimentary
      tissue phenotyping of the specimens which are obtained contribute to this low diagnostic
      yield. In recent years, there has been increasing interest in the use of electro-anatomic
      mapping (EAM) to help identify areas of myocardium with discrete pathology based on
      abnormalities in intra-cardiac electrogram voltage and morphologies. Therefore, the primary
      objective of this protocol is to provide definitive evidence that EAM-guided biopsy leads to
      a superior diagnostic yield compared with conventional fluoroscopy-guided biopsy in patients
      with new-onset and persistent NICM.
observational model: Cohort
time perspective: Prospective
measure: Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.
time frame: November 2018
description: Additional biopsies
intervention type: Device
intervention name: additional biopsies
description: additional biopsies
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Francis Marchlinski, MD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiomyopathies
sharing ipd: Undecided