<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/NCT04431544</url>
  </required_header>
  <id_info>
    <org_study_id>CLP-20</org_study_id>
    <nct_id>NCT04431544</nct_id>
  </id_info>
  <brief_title>AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)</brief_title>
  <official_title>AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acutus Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acutus Medical</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      AcQMap Registry is an observation study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AcQMap Registry is an observational, prospective, multi-center, open-label registry designed&#xD;
      to provide clinical data regarding the commercial, real-life experience with the diagnostic&#xD;
      AcQMap System.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 29, 2020</start_date>
  <completion_date type="Anticipated">August 15, 2029</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2029</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Procedural Ablation Outcomes</measure>
    <time_frame>12 hours</time_frame>
    <description>Number of participants who had termination of ablated arrhythmia's to Sinus Rhythm or another arrhythmia within 12 hours post ablation procedure with or without electrical or pharmacological cardioversion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Long-term Outcome</measure>
    <time_frame>3 years</time_frame>
    <description>First-procedure freedom from any arrhythmia on and/or off AADs, throughout the follow-up period, excluding events in the initial 90 days following the procedure (blanking period).</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Ablation of Arrhythmia's</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AcQMap System</intervention_name>
    <description>To evaluate procedural and long-term outcomes when using the diagnostic AcQMap System as an imaging and mapping system for ablation of arrhythmias in accordance with the Instructions for Use (IFU).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any participant 18 years of age or older. Currently scheduled for an ablation of an&#xD;
        arrhythmia utilizing the diagnostic AcQMap System.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male or female 18 years of age or older. Currently scheduled for an ablation of an&#xD;
        arrhythmia utilizing the diagnostic AcQMap System.&#xD;
&#xD;
        Willingness, ability and commitment to participate in baseline and follow-up evaluations&#xD;
        for the full length of the study.&#xD;
&#xD;
        Willing and able to give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        In the opinion of the Investigator, any known contraindications to an ablation procedure.&#xD;
&#xD;
        Current enrollment in any study protocol sponsored by Acutus Medical. Any other condition&#xD;
        that, in the judgment of the investigator, makes the participant a poor candidate for this&#xD;
        procedure, the study, or compliance with the protocol (includes vulnerable patient&#xD;
        population, mental illness, addictive disease, extensive travel away from the research&#xD;
        center, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Karen Stephens</last_name>
    <phone>4422326080</phone>
    <email>karen.stephens@acutus.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Deana Pierce</last_name>
    <phone>4422326087</phone>
    <email>deana.pierce@acutus.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Grandview Medical Group Research</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35243</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Banner University Medical Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Weiss, MD</last_name>
      <email>peteweissmd@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Jimmy Schohn</last_name>
      <email>James.schohn@bannerhealth.com</email>
    </contact_backup>
    <investigator>
      <last_name>Peter Weiss, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St Jude Medical Center</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fred Han, MD</last_name>
      <email>fredhan@health.ucsd.edu</email>
    </contact>
    <contact_backup>
      <last_name>Benyraemon Batenga</last_name>
      <email>bbatenga@health.ucsd.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Fred Han, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Keck School of Medicine of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Junaid Zaman, MD</last_name>
      <email>Junaid.Zaman@med.usc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Melissa Ramos, RN</last_name>
      <phone>323-442-7983</phone>
      <email>Melissa.Ramos@med.usc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Junaid Zaman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mission Heritage Mission Viejo - Cardiac Electrophysiology</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Eisenhower Medical Center</name>
      <address>
        <city>Rancho Mirage</city>
        <state>California</state>
        <zip>92270</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dignity Health Research Institute</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Washington Hospital (part of MedStar Health Research Institute)</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Bethesda Hospital East</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33435</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yoel Vivas, MD</last_name>
      <email>yoelmd@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Eric Marquez</last_name>
      <phone>305 763-0891</phone>
      <email>emarquez@rpna.net</email>
    </contact_backup>
    <investigator>
      <last_name>Yoel Vivas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clearwater Cardiovascular Consultants</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Garcia, MD</last_name>
      <email>rschJCG@cccheart.com</email>
    </contact>
    <contact_backup>
      <last_name>Michele Cameron, RN, BSN, MBA</last_name>
      <email>cameronm@cccheart.com</email>
    </contact_backup>
    <investigator>
      <last_name>Juan Garcia, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Morton Plant Hospital</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Ascension St. Vincent's Medical Center Riverside</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Celebration Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rasheed Siddiqui, MD</last_name>
      <email>Siddiqui.u@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Delores Barnes, RN</last_name>
      <email>Delores.Barnes@AdventHealth.com</email>
    </contact_backup>
    <investigator>
      <last_name>Rasheed Siddiqui, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bayfront (Orlando Health)</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Masvidal, MD</last_name>
      <email>masvidal5@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Kim Delmontagne, RN</last_name>
      <email>Kimberly.Delmontagne@orlandohealth.com</email>
    </contact_backup>
    <investigator>
      <last_name>Daniel Masvidal, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sarasota Memorial Research Institute</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Moretta, MD</last_name>
      <email>moretta.md@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Colleen Linder, RN</last_name>
      <email>Colleen-lindner@smh.com</email>
    </contact_backup>
    <investigator>
      <last_name>Antonio Moretta, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Health System</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83704</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Margot Vloka, MD</last_name>
      <email>Margot.vloka@saintalphonsus.org</email>
    </contact>
    <contact_backup>
      <last_name>Jennifer Yehle</last_name>
      <email>jennifer.yehle@saintalphonsus.org</email>
    </contact_backup>
    <investigator>
      <last_name>Margot Vloka, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kansas City Heart Rhythm Institute</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dhanunjaya Lakkireddy, MD</last_name>
      <phone>913-449-1297</phone>
      <email>Dhanunjaya.Lakkireddy@hcahealthcare.com</email>
    </contact>
    <contact_backup>
      <last_name>Jenny Bush, BSN</last_name>
      <phone>913-253-3060</phone>
      <email>Jennifer.Bush2@HCAHealthcare.com</email>
    </contact_backup>
    <investigator>
      <last_name>Dhanunjaya Lakkireddy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baptist Lexington Medical Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joshua C Greenberg, MD</last_name>
      <email>jgreenb1@hfhs.org</email>
    </contact>
    <contact_backup>
      <last_name>Briita Wanhala</last_name>
      <email>BWanhal1@hfhs.org</email>
    </contact_backup>
    <investigator>
      <last_name>Joshua C Greenberg, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nevada Heart and Vascular</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arjun Gururaj, MD</last_name>
      <email>gone.to.earth@mac.com</email>
    </contact>
    <contact_backup>
      <last_name>Alicia Bracken</last_name>
      <phone>702-240-6482</phone>
      <phone_ext>7272</phone_ext>
      <email>aliciab@nevadaheart.com</email>
    </contact_backup>
    <investigator>
      <last_name>Arjun Gururaj, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan Sussman, MD</last_name>
      <email>jon.suss@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Diane Agar, MS, RN</last_name>
      <phone>973-971-4205</phone>
      <email>Diane.agar@atlantichealth.org</email>
    </contact_backup>
    <investigator>
      <last_name>Jonathan Sussman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine, New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steven Markowitz, MD</last_name>
      <email>smarkow@med.cornell.edu</email>
    </contact>
    <contact_backup>
      <last_name>Heather Glum, RN</last_name>
      <phone>212-746-4620</phone>
      <email>hep2011@med.cornell.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Steven Markowitz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ProMedica Physician Cardiology</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Penn State Health Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033-0850</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Texas Cardiac Arrhythmia Research Foundation</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78750</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Methodist Healthcare</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78249</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Pederson, MD</last_name>
      <email>epdocdp@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Maurene Cantu, RN</last_name>
      <email>maurene.cantu@hcahealthcare.com</email>
    </contact_backup>
    <investigator>
      <last_name>David Pederson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Sacred Heart Medical Center</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ablation</keyword>
  <keyword>atrial arrhythmia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</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/NCT04431544
org study id: CLP-20
nct id: NCT04431544
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
AcQMap Registry is an observation study
AcQMap Registry is an observational, prospective, multi-center, open-label registry designed
      to provide clinical data regarding the commercial, real-life experience with the diagnostic
      AcQMap System.
observational model: Case-Only
time perspective: Prospective
measure: Procedural Ablation Outcomes
time frame: 12 hours
description: Number of participants who had termination of ablated arrhythmia's to Sinus Rhythm or another arrhythmia within 12 hours post ablation procedure with or without electrical or pharmacological cardioversion
measure: Long-term Outcome
time frame: 3 years
description: First-procedure freedom from any arrhythmia on and/or off AADs, throughout the follow-up period, excluding events in the initial 90 days following the procedure (blanking period).
intervention type: Device
intervention name: AcQMap System
description: To evaluate procedural and long-term outcomes when using the diagnostic AcQMap System as an imaging and mapping system for ablation of arrhythmias in accordance with the Instructions for Use (IFU).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Karen Stephens
phone: 4422326080
email: karen.stephens@acutus.com
last name: Deana Pierce
phone: 4422326087
email: deana.pierce@acutus.com
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Withdrawn
country: United States
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
sharing ipd: Undecided