<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/NCT03779841</url>
  </required_header>
  <id_info>
    <org_study_id>1925-201-008</org_study_id>
    <secondary_id>2017-004399-68</secondary_id>
    <nct_id>NCT03779841</nct_id>
  </id_info>
  <brief_title>Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA)</brief_title>
  <official_title>A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN-151607) Injections Into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, randomized, double-blind, placebo-controlled, parallel group,&#xD;
      dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607)&#xD;
      injections into the epicardial fat pads, foci of ganglionic plexi, to prevent Post-Operative&#xD;
      Atrial Fibrillation (POAF) in patients undergoing open-chest cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">March 2, 2023</completion_date>
  <primary_completion_date type="Actual">March 24, 2022</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants with at least 1 continuous atrial fibrillation (AF) episode ≥ 30 seconds during the first 30 days post-surgery.</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of time spent in AF (AF burden) during the first 30 days post-surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with at least 1 event of symptomatic AF during the first 30 days post-surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first occurrence of AF during the first 30 days post-surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with at least 1 continuous AF episode ≥ 2 minutes during the first 30 days post-surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with at least 1 continuous AF episode ≥ 5 minutes during the first 30 days post-surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with at least 1 continuous AF episode ≥ 30 minutes during the first 30 days post-surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with at least 1 continuous AF episode ≥ 1 hour during the first 30 days post-surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with at least 1 continuous AF episode ≥ 4 hours during the first 30 days post-surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with at least 1 continuous AF episode ≥ 24 hours during the first 30 days post-surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with at least 1 continuous AF episode ≥ 6 hours during the first 30 days post-surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with at least 1 continuous AF episode ≥ 12 hours during the first 30 days post-surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">330</enrollment>
  <condition>Post-Operative Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>AGN-151607 (250 U)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injections of 50 U will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGN-151607 (125 U)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injections of 25 U will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Injections of placebo will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AGN-151607</intervention_name>
    <description>Injections will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.</description>
    <arm_group_label>AGN-151607 (125 U)</arm_group_label>
    <arm_group_label>AGN-151607 (250 U)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Injections of placebo will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Capable of giving signed informed consent, which includes compliance with the&#xD;
             requirements and restrictions listed in the informed consent form.&#xD;
&#xD;
          -  Written informed consent from the participant has been obtained prior to any&#xD;
             study-related procedures&#xD;
&#xD;
          -  Written documentation has been obtained in accordance with the relevant country and&#xD;
             local privacy requirements, where applicable (eg. Written Authorization for Use and&#xD;
             Release of Health and Research Study Information [US sites] and written Data&#xD;
             Protection consent (European Union sites).&#xD;
&#xD;
          -  Participants who are scheduled to undergo open-chest cardiac surgery. Includes:&#xD;
             coronary artery bypass graft (CABG) and/or valve repair/replacement. Inclusionary&#xD;
             valve repair/replacement procedures for the primary reason for surgery include: Aortic&#xD;
             valve repair/replacement, Mitral valve repair/replacement, Combination of aortic and&#xD;
             tricuspid valve repair/replacement, Combination of mitral and tricuspid valve&#xD;
             repair/replacement CABG/valve combination procedures (when valvular procedure is one&#xD;
             of the 4 sub-bulleted procedures immediately above), Left Atrial Appendage (LAA)&#xD;
             procedures are allowed if CABG and/or valve repair or replacement is the qualifying&#xD;
             surgical procedure, but is not a qualifying surgical procedure on its own.&#xD;
&#xD;
          -  A male participant must agree to use contraception until Day 60 and refrain from&#xD;
             donating sperm during this period.&#xD;
&#xD;
          -  A female participant is eligible to participate if she is not pregnant (has a negative&#xD;
             urine pregnancy result prior to randomization) not breastfeeding, and at least 1 of&#xD;
             the following conditions applies: Not a woman of childbearing potential (WOCBP). A&#xD;
             WOCBP who agrees to follow the contraceptive guidance until after Day 60.&#xD;
&#xD;
          -  In sinus rhythm for the last 48 hours prior to randomization based on standard-of care&#xD;
             assessments and study ECGs (note: continuous ECG monitoring for 48 hours is not&#xD;
             required; prior history of paroxysmal AF is acceptable)&#xD;
&#xD;
          -  Willing to wear an electrocardiogram (ECG) patch for a full 30 days post-surgery and&#xD;
             for 7 days after each study visit&#xD;
&#xD;
          -  Able, as assessed by the investigator, and willing to follow study instructions and&#xD;
             likely to complete required study visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any uncontrolled clinically significant medical condition other than the one under&#xD;
             study that, in the investigator's opinion, would put the participant at an&#xD;
             unacceptable risk with exposure to botulinum toxin type A.&#xD;
&#xD;
          -  Exclusionary valve repair/replacement procedures include: Combination of aortic and&#xD;
             mitral valve repair/replacement, Isolated tricuspid valve repair/replacement.&#xD;
&#xD;
          -  Any medical condition that may put the participant at increased risk with exposure to&#xD;
             botulinum toxin type A, including diagnosed muscular dystrophy (eg, Duchenne's&#xD;
             muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral&#xD;
             sclerosis, mitochondrial disease, or any other significant disease which might&#xD;
             interfere with neuromuscular function.&#xD;
&#xD;
          -  Participants with presence or history of any of the following within 3 months prior to&#xD;
             the Day 1 visit that may indicate a vulnerable respiratory state per the&#xD;
             investigator's clinical judgment: aspiration pneumonia, lower respiratory tract&#xD;
             infections, uncontrolled asthma, severe chronic obstructive pulmonary disease, or&#xD;
             otherwise compromised respiratory function.&#xD;
&#xD;
          -  Permanent/persistent atrial fibrillation (AF)&#xD;
&#xD;
          -  Has a known allergy or sensitivity to any botulinum toxin type A preparation. - Has a&#xD;
             known allergy or sensitivity to medical adhesive (eg, ECG patch adhesive;&#xD;
             hydrogel-based adhesive).&#xD;
&#xD;
          -  Severe (&gt; 55 mm left atrial diameter) left atrial enlargement&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) &lt; 25%&#xD;
&#xD;
          -  Presence or history of symptomatic atrioventricular block &gt; 1st degree within the last&#xD;
             30 days (note: presence of a pacemaker is not exclusionary per se) - Class I or III&#xD;
             antiarrhythmic drugs unless proper washout was documented&#xD;
&#xD;
          -  Botulinum toxin type A (of any serotype) use within 6 months of randomization&#xD;
&#xD;
          -  Has been immunized for any botulinum toxin type A serotype as determined by&#xD;
             participant medical history&#xD;
&#xD;
          -  Preoperative need for inotropes/vasopressors or intra-aortic balloon pump&#xD;
&#xD;
          -  Prior open-chest, sternotomy cardiac surgery - History of ablation for AF&#xD;
&#xD;
          -  Planned ablation procedure for AF at the time of surgery&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Current enrollment in an investigational drug or device study or participation in such&#xD;
             a study within 30 days of entry into this study&#xD;
&#xD;
          -  Participants have diagnostic assessments which in the opinion of the investigator&#xD;
             prevent participation in the study&#xD;
&#xD;
          -  Impaired prognosis defined as EuroSCORE II &gt; 7% perioperative mortality at screening&#xD;
             is exclusionary.&#xD;
&#xD;
          -  Females who are pregnant, nursing, or planning a pregnancy during the study&#xD;
&#xD;
          -  The participant has a condition or is in a situation which, in the investigator's&#xD;
             opinion, may put the participant at significant risk, may confound the study results,&#xD;
             or may interfere significantly with the participant's participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Med /ID# 236922</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305-2200</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale New Haven Hospital - Yale School of Medicine /ID# 238221</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510-3206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medstar Washington Hospital Center /ID# 234322</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010-3017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Saint Joseph's Hospital /ID# 234334</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342-1731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lutheran Medical Group /ID# 237990</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center /ID# 238004</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121-2429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center /ID# 234352</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201-1544</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan /ID# 236228</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University-School of Medicine /ID# 238121</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center /ID# 237530</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 234449</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Hospital /ID# 237231</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center /ID# 234314</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705-4410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina University /ID# 237820</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27858</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center /ID# 234408</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina /ID# 236476</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Research Institute /ID# 235937</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah /ID# 237601</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112-5500</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia /ID# 237611</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Wien /ID# 238259</name>
      <address>
        <city>Vienna</city>
        <state>Wien</state>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ottawa Heart Institute /ID# 236012</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital /ID# 237680</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Heart Insitute /ID# 234859</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM - Centre hospitalier de l'Universite de Montréal /ID# 238163</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 3E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 234316</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4J 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 237166</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Harburg-Hamburg /ID# 234855</name>
      <address>
        <city>Hamburg</city>
        <zip>21075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST degli Spedali Civili di Brescia /ID# 234861</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Medisch Centrum /ID# 237113</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic. University of Barcelona /ID# 234853</name>
      <address>
        <city>Barcelona</city>
        <zip>08039</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orebro University Hospital Sweden /ID# 236047</name>
      <address>
        <city>Orebro</city>
        <state>Orebro Lan</state>
        <zip>702 12</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Plymouth NHS Trust /ID# 234423</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 5FP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <disposition_first_submitted>February 27, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>February 27, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 1, 2023</disposition_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 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>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03779841
org study id: 1925-201-008
secondary id: 2017-004399-68
nct id: NCT03779841
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group,
      dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607)
      injections into the epicardial fat pads, foci of ganglionic plexi, to prevent Post-Operative
      Atrial Fibrillation (POAF) in patients undergoing open-chest cardiac surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of participants with at least 1 continuous atrial fibrillation (AF) episode ≥ 30 seconds during the first 30 days post-surgery.
time frame: 30 days
measure: Percentage of time spent in AF (AF burden) during the first 30 days post-surgery
time frame: 30 days
measure: Percentage of participants with at least 1 event of symptomatic AF during the first 30 days post-surgery
time frame: 30 days
measure: Time to first occurrence of AF during the first 30 days post-surgery
time frame: 30 days
measure: Percentage of participants with at least 1 continuous AF episode ≥ 2 minutes during the first 30 days post-surgery
time frame: 30 days
measure: Percentage of participants with at least 1 continuous AF episode ≥ 5 minutes during the first 30 days post-surgery
time frame: 30 days
measure: Percentage of participants with at least 1 continuous AF episode ≥ 30 minutes during the first 30 days post-surgery
time frame: 30 days
measure: Percentage of participants with at least 1 continuous AF episode ≥ 1 hour during the first 30 days post-surgery
time frame: 30 days
measure: Percentage of participants with at least 1 continuous AF episode ≥ 4 hours during the first 30 days post-surgery
time frame: 30 days
measure: Percentage of participants with at least 1 continuous AF episode ≥ 24 hours during the first 30 days post-surgery
time frame: 30 days
measure: Percentage of participants with at least 1 continuous AF episode ≥ 6 hours during the first 30 days post-surgery
time frame: 30 days
measure: Percentage of participants with at least 1 continuous AF episode ≥ 12 hours during the first 30 days post-surgery
time frame: 30 days
arm group label: AGN-151607 (250 U)
arm group type: Experimental
description: Injections of 50 U will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
arm group label: AGN-151607 (125 U)
arm group type: Experimental
description: Injections of 25 U will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
arm group label: Placebo
arm group type: Placebo Comparator
description: Injections of placebo will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
intervention type: Drug
intervention name: AGN-151607
description: Injections will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
arm group label: AGN-151607 (125 U)
arm group label: AGN-151607 (250 U)
intervention type: Drug
intervention name: Placebo
description: Injections of placebo will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
arm group label: Placebo
criteria: 
gender: All
minimum age: 55 Years
maximum age: 90 Years
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
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country: Austria
country: Canada
country: Germany
country: Italy
country: Netherlands
country: Spain
country: Sweden
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
ipd url: https://vivli.org/ourmember/abbvie/