<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/NCT04467905</url>
  </required_header>
  <id_info>
    <org_study_id>MSP-2017-5001</org_study_id>
    <nct_id>NCT04467905</nct_id>
  </id_info>
  <brief_title>ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2</brief_title>
  <official_title>Multi-Centre, Placebo-Controlled, Phase 2 Study of Etripamil Nasal Spray (NS) for the Reduction of Ventricular Rate in Patients With Atrial Fibrillation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milestone Pharmaceuticals Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Montreal Health Innovations Coordinating Center (MHICC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>JSS Medical Research Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Milestone Pharmaceuticals Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many patients with atrial fibrillation experience persistent tachycardia with episodes of&#xD;
      rapid ventricular rate despite chronic treatment to reduce ventricular rate. The objectives&#xD;
      of this study are to demonstrate the superiority of a nasal spray of etripamil over placebo,&#xD;
      in reducing ventricular rate in patients with atrial fibrillation; and to evaluate the safety&#xD;
      and efficacy of etripamil Nasal Spray in patients with atrial fibrillation (AF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the&#xD;
      effects of etripamil Nasal Spray in patients with atrial fibrillation (AF). This study&#xD;
      includes Screening, the Treatment Period and Follow-up procedures.&#xD;
&#xD;
      Each patient will receive placebo or 70 mg of etripamil intranasally; treatment will be&#xD;
      randomized in a 1:1 ratio, to yield 50 evaluable patients with atrial fibrillation in 2&#xD;
      groups of 25.&#xD;
&#xD;
      Patients with atrial fibrillation (AF) will be selected by the Investigator. The screening&#xD;
      procedures will include obtaining informed consent, a review of inclusion/exclusion criteria,&#xD;
      a complete physical examination, and recording of any concomitant medications.&#xD;
&#xD;
      After screening procedures are complete, eligible patients will be randomized to receive&#xD;
      etripamil or placebo. Heart rate will be measured via Holter ECG (Electrocardiogram)10&#xD;
      minutes prior to and immediately before drug administration; patients must exhibit a rapid&#xD;
      ventricular rate (≥110 bpm measured during 1 minute) on the Holter report prior to drug&#xD;
      administration in order to receive the study drug. Blinded study drug will be administered&#xD;
      during Holter ECG (Electrocardiogram) monitoring, which will be conducted for at least 10&#xD;
      minutes prior to and for 6 hours after administration.&#xD;
&#xD;
      Patients will undergo a safety follow-up assessment and return the Holter device&#xD;
      approximately 24 hours post-dose. Patients will also be contacted by phone 7 days post-dosing&#xD;
      for safety follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 19, 2020</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The maximum reduction in ventricular rate, measured on Holter monitoring, within 60 minutes from drug administration.</measure>
    <time_frame>60 minutes post drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The elapsed time from drug administration to nadir (lowest average heart rate) in the 60 minutes post drug administration.</measure>
    <time_frame>60 minutes post drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients achieving ventricular rate of &lt;100 bpm in the 60 minutes post drug administration.</measure>
    <time_frame>60 minutes post drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients with 10% reduction from baseline ventricular rate in the 60 minutes post drug administration.</measure>
    <time_frame>60 minutes post drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients with 20% reduction from baseline ventricular rate in the 60 minutes post drug administration.</measure>
    <time_frame>60 minutes post drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients cardioverting into sinus rhythm in the 60 minutes post drug administration.</measure>
    <time_frame>60 minutes post drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rating of Treatment Satisfaction Questionnaire for Medication (TSQM).</measure>
    <time_frame>60 minutes post drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive a total of 200 μL of placebo ((i.e. 100 μL in each nostril) via the Aptar Pharma Nasal Spray Bidose System. The devices will be prefilled and packaged. Instructions on device usage will be provided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etripamil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a total of 200 μL of etripamil Nasal spray 70 mg via the Aptar Pharma Nasal Spray Bidose System. The devices will be prefilled and packaged. Instructions on device usage will be provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etripamil</intervention_name>
    <description>The formulation of etripamil Nasal Spray will consist of MSP-2017 (etripamil), water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg.</description>
    <arm_group_label>Etripamil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The formulation of placebo will consist of water, sodium acetate, disodium, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid to reproduce the same pH as the etripamil formulation.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A patient will be eligible for study participation if they meet all of the following&#xD;
        criteria:&#xD;
&#xD;
          1. Aged 18 years and over.&#xD;
&#xD;
          2. Has provided written informed consent.&#xD;
&#xD;
          3. Patients with episodes of paroxysmal, persistent or permanent AF (Atrial&#xD;
             Fibrillation), presenting with AF and a ventricular rate ≥110 bpm, measured over 1&#xD;
             minute&#xD;
&#xD;
          4. Patients should receive appropriate antithrombotic therapy as per the applicable&#xD;
             guidelines for atrial fibrillation management (e.g., Canadian Cardiovascular Society&#xD;
             (CCS) guidelines / European Society of Cardiology (ESC) guidelines).&#xD;
&#xD;
               1. Etripamil (a calcium channel blocker) is intended for acute rate control only. If&#xD;
                  rhythm control is desired (outside of the present protocol), anticoagulation as&#xD;
                  per guidelines may start after the administration of study drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A patient will be excluded from the study if they meet any of the following criteria:&#xD;
&#xD;
          1. Has evidence of atrial flutter (ECG) at presentation.&#xD;
&#xD;
          2. Has a history of stroke,Transient Ischemic Attack (TIA) or peripheral embolism within&#xD;
             the last 3 months.&#xD;
&#xD;
          3. Has received by IV route any of the following within one hour before study drug&#xD;
             administration: flecainide, procainamide, digoxin, beta-blocker, or calcium channel&#xD;
             blocker.&#xD;
&#xD;
          4. Has signs and symptoms of severe congestive heart failure at presentation (e.g.&#xD;
             tachypnea, oxygen desaturation &lt;90% unless due to known pulmonary disease, pulmonary&#xD;
             rales, sign of peripheral hypoperfusion).&#xD;
&#xD;
          5. Hemodynamic instability, with systolic blood pressure &lt;90 mmHg or diastolic blood&#xD;
             pressure &lt;60 mmHg.&#xD;
&#xD;
          6. Known uncorrected severe aortic or mitral stenosis.&#xD;
&#xD;
          7. Hypertrophic cardiomyopathy with outflow tract obstruction.&#xD;
&#xD;
          8. Has a history of second- or third-degree atrioventricular block.&#xD;
&#xD;
          9. Regular rhythm suggesting a complete Atrioventricular (AV) block.&#xD;
&#xD;
         10. Has a history or evidence of torsades de pointes, sick sinus syndrome, or Brugada&#xD;
             syndrome.&#xD;
&#xD;
         11. Evidence of Acute Coronary Syndrome within the last 12 months except if patient was&#xD;
             successfully revascularized.&#xD;
&#xD;
         12. Positive pregnancy test result at screening, and females of childbearing potential who&#xD;
             do not agree to use adequate method of contraception for the duration of the study.&#xD;
&#xD;
         13. Has evidence of any clinically significant acute or chronic condition of the nasal&#xD;
             cavity (e.g., rhinitis or deviated septum) which could interfere with administration&#xD;
             of the study drug in either or both nasal cavities.&#xD;
&#xD;
         14. Has a history of sensitivity to verapamil.&#xD;
&#xD;
         15. Has previously participated in a clinical study for etripamil.&#xD;
&#xD;
         16. Has a history of sensitivity to any components of the investigational product.&#xD;
&#xD;
         17. Signs of alcohol or drug intoxication at the time of presentation which, in the&#xD;
             opinion of the Investigator, would impact the validity of study results.&#xD;
&#xD;
         18. Is currently participating in another drug or device study, or has received an&#xD;
             investigational drug or device within 30 days of Screening.&#xD;
&#xD;
         19. Has evidence of clinically significant cardiovascular, endocrine, gastrointestinal,&#xD;
             hematologic, hepatic, immunologic, neurologic, oncologic, pulmonary, psychiatric, or&#xD;
             renal disease or any other condition which, in the opinion of the Investigator, would&#xD;
             jeopardize the safety of the patient or impact the validity of study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Denis Roy, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montreal Heart Institute (MHI)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nathalie Thermil</last_name>
    <phone>450-912-6783</phone>
    <email>nthermil@milestonepharma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Silvia Shardonofsky, M.D</last_name>
    <phone>450-912-6777</phone>
    <email>sshardonofsky@milestonepharma.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>QEII HSC - Nova Scotia Health Authority</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Science</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L2L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>PACE (Partners in Advanced Cardiac Evaluation)</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y 2P6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital General &amp; Civic Campus Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut de Cardiologie de Montreal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H1T 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CIUSSS du Nord-de-l'Île-de-Montréal - Hôpital du Sacré-Cœur</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4J 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CISSS Bas-Saint-Laurent / Hôpital de Rimouski</name>
      <address>
        <city>Rimouski</city>
        <state>Quebec</state>
        <zip>G5L 5T1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CISSS des Laurentides / Unité de recherche clinique</name>
      <address>
        <city>Saint-Jérôme</city>
        <state>Quebec</state>
        <zip>J7Z 5T3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CIUSSS de l'Estrie - CHU</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CISSS de Lanaudière - Hôpital Pierre-Le Gardeur</name>
      <address>
        <city>Terrebonne</city>
        <state>Quebec</state>
        <zip>J6V 2H2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jeroen Bosch Ziekenhuis Rijnstate Ziekenhuis</name>
      <address>
        <city>Arnhem</city>
        <zip>6815 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jeroen Bosch Ziekenhuis</name>
      <address>
        <city>Den Bosch</city>
        <zip>5223 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Slingeland Ziekenhuis</name>
      <address>
        <city>Doetinchem</city>
        <zip>7009 BL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Treant Zorggroep</name>
      <address>
        <city>Emmen</city>
        <zip>7824 AA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Elkerliek Ziekenhuis</name>
      <address>
        <city>Helmond</city>
        <zip>5707 HA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Franciscus Gasthuis</name>
      <address>
        <city>Rotterdam</city>
        <zip>3045 PM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gelre Ziekenhuizen</name>
      <address>
        <city>Zutphen</city>
        <zip>7207 AE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>February 23, 2023</last_update_submitted>
  <last_update_submitted_qc>February 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>ventricular rate control</keyword>
  <keyword>rapid ventricular rate</keyword>
  <keyword>etripamil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etripamil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04467905
org study id: MSP-2017-5001
nct id: NCT04467905
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Many patients with atrial fibrillation experience persistent tachycardia with episodes of
      rapid ventricular rate despite chronic treatment to reduce ventricular rate. The objectives
      of this study are to demonstrate the superiority of a nasal spray of etripamil over placebo,
      in reducing ventricular rate in patients with atrial fibrillation; and to evaluate the safety
      and efficacy of etripamil Nasal Spray in patients with atrial fibrillation (AF).
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the
      effects of etripamil Nasal Spray in patients with atrial fibrillation (AF). This study
      includes Screening, the Treatment Period and Follow-up procedures.

      Each patient will receive placebo or 70 mg of etripamil intranasally; treatment will be
      randomized in a 1:1 ratio, to yield 50 evaluable patients with atrial fibrillation in 2
      groups of 25.

      Patients with atrial fibrillation (AF) will be selected by the Investigator. The screening
      procedures will include obtaining informed consent, a review of inclusion/exclusion criteria,
      a complete physical examination, and recording of any concomitant medications.

      After screening procedures are complete, eligible patients will be randomized to receive
      etripamil or placebo. Heart rate will be measured via Holter ECG (Electrocardiogram)10
      minutes prior to and immediately before drug administration; patients must exhibit a rapid
      ventricular rate (≥110 bpm measured during 1 minute) on the Holter report prior to drug
      administration in order to receive the study drug. Blinded study drug will be administered
      during Holter ECG (Electrocardiogram) monitoring, which will be conducted for at least 10
      minutes prior to and for 6 hours after administration.

      Patients will undergo a safety follow-up assessment and return the Holter device
      approximately 24 hours post-dose. Patients will also be contacted by phone 7 days post-dosing
      for safety follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The maximum reduction in ventricular rate, measured on Holter monitoring, within 60 minutes from drug administration.
time frame: 60 minutes post drug administration
measure: The elapsed time from drug administration to nadir (lowest average heart rate) in the 60 minutes post drug administration.
time frame: 60 minutes post drug administration
measure: The percentage of patients achieving ventricular rate of <100 bpm in the 60 minutes post drug administration.
time frame: 60 minutes post drug administration
measure: The percentage of patients with 10% reduction from baseline ventricular rate in the 60 minutes post drug administration.
time frame: 60 minutes post drug administration
measure: The percentage of patients with 20% reduction from baseline ventricular rate in the 60 minutes post drug administration.
time frame: 60 minutes post drug administration
measure: The percentage of patients cardioverting into sinus rhythm in the 60 minutes post drug administration.
time frame: 60 minutes post drug administration
measure: Rating of Treatment Satisfaction Questionnaire for Medication (TSQM).
time frame: 60 minutes post drug administration
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients will receive a total of 200 μL of placebo ((i.e. 100 μL in each nostril) via the Aptar Pharma Nasal Spray Bidose System. The devices will be prefilled and packaged. Instructions on device usage will be provided.
arm group label: Etripamil
arm group type: Experimental
description: Patients will receive a total of 200 μL of etripamil Nasal spray 70 mg via the Aptar Pharma Nasal Spray Bidose System. The devices will be prefilled and packaged. Instructions on device usage will be provided.
intervention type: Drug
intervention name: Etripamil
description: The formulation of etripamil Nasal Spray will consist of MSP-2017 (etripamil), water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg.
arm group label: Etripamil
intervention type: Drug
intervention name: Placebo
description: The formulation of placebo will consist of water, sodium acetate, disodium, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid to reproduce the same pH as the etripamil formulation.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Denis Roy, M.D
role: Principal Investigator
affiliation: Montreal Heart Institute (MHI)
last name: Nathalie Thermil
phone: 450-912-6783
email: nthermil@milestonepharma.com
last name: Silvia Shardonofsky, M.D
phone: 450-912-6777
email: sshardonofsky@milestonepharma.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Canada
country: Netherlands
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Etripamil
sharing ipd: No