<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/NCT04478188</url>
  </required_header>
  <id_info>
    <org_study_id>00000164</org_study_id>
    <nct_id>NCT04478188</nct_id>
  </id_info>
  <brief_title>Pressure Volume Loop</brief_title>
  <official_title>The Use of PV Loop Analysis to Optimize Cardiogenic Shock and Device Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are doing this study and medical record review to measure simultaneous&#xD;
      pressure and volume of the heart called pressure volumes loops before and after ventricular&#xD;
      assist device placement for cardiogenic shock ( a severe form of heart failure). Standard of&#xD;
      care measurements will be the sole measure of clinical determination. The investigators are&#xD;
      measuring these PV loops to help determine which patients heart have recovered and can have&#xD;
      the ventricular assist device removed. The investigators are also using the PV loop to&#xD;
      indicate/correlate with certain outcomes to predict the need for LVAD patients to require&#xD;
      additional support in the form of a right ventricular assist device. The medical record&#xD;
      review will be performed pre-operatively, intra-operatively, and post-operatively until the&#xD;
      day of discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiogenic shock (CS) represents a high risk population that is at risk for both in-hospital&#xD;
      mortality and readmission following discharge. CS can be either left ventricular (LV) or&#xD;
      right ventricular (RV) or of biventricular (BiV) origin. Even in patients with CS treated&#xD;
      with an invasive approach (cardiac catheterization, angioplasty, and coronary bypass&#xD;
      surgery), in-hospital mortality approaches 50%. Other causes of CS mainly include severe&#xD;
      decline in underlying systolic function (from non-ischemic causes such as sepsis, stress, and&#xD;
      progression of systolic left ventricular dysfunction among others), arrhythmias, and&#xD;
      mechanical cardiac complications. Cardiogenic shock in the absence of acute myocardial&#xD;
      infarction (AMI) (non-AMI CS) is excluded from most studies including randomized trials and&#xD;
      remains largely understudied. For many years, the intra-aortic balloon pump was thought to be&#xD;
      helpful in improving outcomes in cardiogenic shock. However, the landmark randomized,&#xD;
      controlled IABP-SHOCK II trial, published in 2012, and concluded that the use of intra-aortic&#xD;
      balloon counter pulsation did not significantly reduce mortality in patients with cardiogenic&#xD;
      shock complicating acute myocardial infarction. This led investigators to search for&#xD;
      alternate temporary mechanical circulatory support systems that might prove effective in&#xD;
      reducing mortality in cardiogenic shock. One such system is the Impella 5.0 and Impella RP&#xD;
      devices. The Impella 5.0 pump in a temporary continuous flow pump approved for hemodynamic&#xD;
      support for left ventricular shock CS patient and the Impella RP for right ventricular shock.&#xD;
      The other system is the Tandem heart pump. The investigators utilize the Impella and the&#xD;
      tandem pump for AMI CS and non-ischemic CS. The device is implanted for bridge to recovery,&#xD;
      bridge to transplant and as a bridge to durable device. The investigators have discovered&#xD;
      that recovery rates following AMI shock are significantly improved with the Impellaand tandem&#xD;
      heart pumps however; identifying which patient recovers remains a mystery. Adequate&#xD;
      parameters do not exist.&#xD;
&#xD;
      Patients who we are unable to recover are transitioned to a durable continuous flow left&#xD;
      ventricular assist devices (CF-LVAD) which are an effective alternative to heart transplant,&#xD;
      but are not risk-free: among the other effects, right ventricle (RV) hemodynamics are&#xD;
      significantly altered by the LVAD implantation. In fact, RV failure occurs in 5% of patients&#xD;
      with implanted CF-LVADs, and leads to a 6-fold increase in the risk of death. Moreover, RV&#xD;
      failure is a major contributing factor in prolonged hospitalizations, and is associated with&#xD;
      a higher risk of bleeding, renal failure, and hypotension. Currently, predictors of RV&#xD;
      failure in patients undergoing LVAD implantation are based entirely on retrospective case&#xD;
      series, often evaluating cohorts of patients with outdated classes of pulsatile-flow&#xD;
      LVADs.Furthermore, right ventricular failure (RVF) still results as the major cause of&#xD;
      morbidity and mortality after LVAD implantation. Despite overall improved outcomes and lower&#xD;
      rates of RVF with the use of the newer, LVAD over pulsatile-flow devices, and development of&#xD;
      clinical prediction scores to facilitate preoperative identification of patients at risk for&#xD;
      RVF after implantation remains elusive. RVF occurs in 13% to 40% of continuous-flow device.&#xD;
      The ability to predict the development of RV failure post LVAD implantation would&#xD;
      significantly improve outcomes as these patients would either have planned RVAD implantation&#xD;
      or receive a total artificial heart implantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ventricular Pressure Volume Loop Analysis</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Three Load independent Parameters will be measured and analyzed at three different time points. Pre, post implant and at explant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival and device explant rate</measure>
    <time_frame>1 year</time_frame>
    <description>Measurement of the proportion of patients that were able to be weaned off the device and percent survival</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cardiogenic Shock</condition>
  <condition>Decompensated Heart Failure</condition>
  <arm_group>
    <arm_group_label>Cardiogenic Shock Patients Needing TMCS</arm_group_label>
    <description>Heart failure patients who undergo TMCS insertion for acute decompensated heart failure and cardiogenic shock.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Measuring Pressure Volume Loop Pre and Post Device Placement</intervention_name>
    <description>To measure simultaneous pressure and volume of the heart (pressure volumes loops) before and after ventricular assist device placement for cardiogenic shock (a severe form of heart failure) and before and after device removal.</description>
    <arm_group_label>Cardiogenic Shock Patients Needing TMCS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All cardiogenic shock patients requiring mechanical circulatory support devices can be&#xD;
        enrolled in the study. The patients chart will be examined for possible exclusion by the PI&#xD;
        or implanting surgeon who is also a co-investigator.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All cardiogenic shock patients requiring temporary mechanical circulatory support (TMCS)&#xD;
        (Impella, Tandem heart and ECMO). Age &gt;=18&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18, All patients requiring ECRP&#xD;
&#xD;
          -  Patients with a Mechanical Aortic Valve&#xD;
&#xD;
          -  Patients with Left Ventricular Thrombus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Danny Ramzy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physician</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Danny Ramzy, MD</last_name>
    <phone>310-423-1877</phone>
    <email>danny.ramzy@cshs.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Soheila Abbassi, MBA</last_name>
    <phone>310-423-5086</phone>
    <email>soheila.abbassi@cshs.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Danny Ramzy, MD</last_name>
      <phone>310-423-1877</phone>
      <email>Danny.Ramzy@cshs.org</email>
    </contact>
    <contact_backup>
      <last_name>Soheila Abbassi, MBA</last_name>
      <phone>310-423-5086</phone>
      <email>soheila.abbassi@cshs.org</email>
    </contact_backup>
    <investigator>
      <last_name>Danny Ramzy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Danny Ramzy</investigator_full_name>
    <investigator_title>Director, Robotic Cardiac Surgery, Principal Investigator, Assosiate Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Cardiogenic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>At this time there are no plans to share individual participant data with other researchers</ipd_description>
  </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/NCT04478188
org study id: 00000164
nct id: NCT04478188
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators are doing this study and medical record review to measure simultaneous
      pressure and volume of the heart called pressure volumes loops before and after ventricular
      assist device placement for cardiogenic shock ( a severe form of heart failure). Standard of
      care measurements will be the sole measure of clinical determination. The investigators are
      measuring these PV loops to help determine which patients heart have recovered and can have
      the ventricular assist device removed. The investigators are also using the PV loop to
      indicate/correlate with certain outcomes to predict the need for LVAD patients to require
      additional support in the form of a right ventricular assist device. The medical record
      review will be performed pre-operatively, intra-operatively, and post-operatively until the
      day of discharge.
Cardiogenic shock (CS) represents a high risk population that is at risk for both in-hospital
      mortality and readmission following discharge. CS can be either left ventricular (LV) or
      right ventricular (RV) or of biventricular (BiV) origin. Even in patients with CS treated
      with an invasive approach (cardiac catheterization, angioplasty, and coronary bypass
      surgery), in-hospital mortality approaches 50%. Other causes of CS mainly include severe
      decline in underlying systolic function (from non-ischemic causes such as sepsis, stress, and
      progression of systolic left ventricular dysfunction among others), arrhythmias, and
      mechanical cardiac complications. Cardiogenic shock in the absence of acute myocardial
      infarction (AMI) (non-AMI CS) is excluded from most studies including randomized trials and
      remains largely understudied. For many years, the intra-aortic balloon pump was thought to be
      helpful in improving outcomes in cardiogenic shock. However, the landmark randomized,
      controlled IABP-SHOCK II trial, published in 2012, and concluded that the use of intra-aortic
      balloon counter pulsation did not significantly reduce mortality in patients with cardiogenic
      shock complicating acute myocardial infarction. This led investigators to search for
      alternate temporary mechanical circulatory support systems that might prove effective in
      reducing mortality in cardiogenic shock. One such system is the Impella 5.0 and Impella RP
      devices. The Impella 5.0 pump in a temporary continuous flow pump approved for hemodynamic
      support for left ventricular shock CS patient and the Impella RP for right ventricular shock.
      The other system is the Tandem heart pump. The investigators utilize the Impella and the
      tandem pump for AMI CS and non-ischemic CS. The device is implanted for bridge to recovery,
      bridge to transplant and as a bridge to durable device. The investigators have discovered
      that recovery rates following AMI shock are significantly improved with the Impellaand tandem
      heart pumps however; identifying which patient recovers remains a mystery. Adequate
      parameters do not exist.

      Patients who we are unable to recover are transitioned to a durable continuous flow left
      ventricular assist devices (CF-LVAD) which are an effective alternative to heart transplant,
      but are not risk-free: among the other effects, right ventricle (RV) hemodynamics are
      significantly altered by the LVAD implantation. In fact, RV failure occurs in 5% of patients
      with implanted CF-LVADs, and leads to a 6-fold increase in the risk of death. Moreover, RV
      failure is a major contributing factor in prolonged hospitalizations, and is associated with
      a higher risk of bleeding, renal failure, and hypotension. Currently, predictors of RV
      failure in patients undergoing LVAD implantation are based entirely on retrospective case
      series, often evaluating cohorts of patients with outdated classes of pulsatile-flow
      LVADs.Furthermore, right ventricular failure (RVF) still results as the major cause of
      morbidity and mortality after LVAD implantation. Despite overall improved outcomes and lower
      rates of RVF with the use of the newer, LVAD over pulsatile-flow devices, and development of
      clinical prediction scores to facilitate preoperative identification of patients at risk for
      RVF after implantation remains elusive. RVF occurs in 13% to 40% of continuous-flow device.
      The ability to predict the development of RV failure post LVAD implantation would
      significantly improve outcomes as these patients would either have planned RVAD implantation
      or receive a total artificial heart implantation.
observational model: Other
time perspective: Prospective
measure: Ventricular Pressure Volume Loop Analysis
time frame: Up to 90 days
description: Three Load independent Parameters will be measured and analyzed at three different time points. Pre, post implant and at explant
measure: Survival and device explant rate
time frame: 1 year
description: Measurement of the proportion of patients that were able to be weaned off the device and percent survival
arm group label: Cardiogenic Shock Patients Needing TMCS
description: Heart failure patients who undergo TMCS insertion for acute decompensated heart failure and cardiogenic shock.
intervention type: Other
intervention name: Measuring Pressure Volume Loop Pre and Post Device Placement
description: To measure simultaneous pressure and volume of the heart (pressure volumes loops) before and after ventricular assist device placement for cardiogenic shock (a severe form of heart failure) and before and after device removal.
arm group label: Cardiogenic Shock Patients Needing TMCS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Danny Ramzy, MD
role: Principal Investigator
affiliation: Physician
last name: Danny Ramzy, MD
phone: 310-423-1877
email: danny.ramzy@cshs.org
last name: Soheila Abbassi, MBA
phone: 310-423-5086
email: soheila.abbassi@cshs.org
facility: 
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Danny Ramzy
investigator title: Director, Robotic Cardiac Surgery, Principal Investigator, Assosiate Professor of Surgery
mesh term: Shock, Cardiogenic
sharing ipd: Undecided
ipd description: At this time there are no plans to share individual participant data with other researchers