<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/NCT04488120</url>
  </required_header>
  <id_info>
    <org_study_id>Occ201201</org_study_id>
    <nct_id>NCT04488120</nct_id>
  </id_info>
  <brief_title>Occlutech Septal Occluder (Figulla Flex II) Study</brief_title>
  <official_title>A Randomized, Controlled,Multi-Centre Trial of the Efficacy and Safety of the Occlutech Septal Occluder(Figulla Flex II) Compared to the AGA Septal Occluder(Amplatzer ASO) for Transcatheter Closure of Secundum ASD in Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Occlutech International AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Occlutech International AB</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of the study are:&#xD;
&#xD;
        -  To determine the efficacy of the Figulla Flex II device compared with that of the&#xD;
           Amplatzer ASO device for transcatheter closure of secundum atrial septal defects&#xD;
&#xD;
        -  To determine the safety of the Figulla Flex II device compared with that of the&#xD;
           Amplatzer ASO device for transcatheter closure of secundum atrial septal defects&#xD;
&#xD;
      This is a randomized, controlled, multi-centre trial of the efficacy and safety of the&#xD;
      Occlutech septal occluder (Figulla Flex II) compared to the AGA septal occluder (Amplatzer&#xD;
      ASO) for transcatheter closure of secundum atrial septal defects in patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion criteria A patient will be eligible for study participation if he/she meets the&#xD;
      following criteria:&#xD;
&#xD;
        1. Able to fluently speak and understand the language in which the study is being conducted&#xD;
&#xD;
        2. Has ostium secundum atrial septal defect&#xD;
&#xD;
        3. Has a defect hole with a diameter of &lt; 38 mm&#xD;
&#xD;
        4. Has a left-to-right shunt with a Qp/Qs ratio of . 1.5:1 or the presence of right&#xD;
           ventricular volume overload determined by transthoracic echo (TTE) or clinical symptoms&#xD;
           due to the atrial septal defect&#xD;
&#xD;
        5. Has a distance of &gt; 5 mm from the margins of the defect(s) to the coronary sinus,&#xD;
           arterioventricular (AV) valves and right upper pulmonary vein as measured by&#xD;
           echocardiography&#xD;
&#xD;
        6. Agrees to participate in the study and comply with the follow-up schedule&#xD;
&#xD;
        7. Is willing to freely give (or Legally Authorized Representative is willing to freely&#xD;
           give) Informed Consent prior to treatment&#xD;
&#xD;
        8. Willing to return for the post-treatment evaluation. Exclusion criteria&#xD;
&#xD;
      A patient will be excluded from the study if he/she meets the following criteria:&#xD;
&#xD;
        1. Has multiple defects which can�ft adequately be covered by the device&#xD;
&#xD;
        2. Has associated congenital cardiac anomalies which require cardiac surgery&#xD;
&#xD;
           a. Has a known sensitivity to contrast media that cannot be controlled adequately with&#xD;
           pre-medication.&#xD;
&#xD;
        3. Patient is currently participating in another clinical device or drug trial that has not&#xD;
           completed its primary endpoint or that will clinically confound the current study&#xD;
           endpoints or does not permit subjects to participate in other studies. Typically,&#xD;
           subjects that are involved in the long-term surveillance phase of a clinical study are&#xD;
           eligible.&#xD;
&#xD;
        4. Has ostium primum atrial septal defects&#xD;
&#xD;
        5. Has sinus venosus atrial septal defects&#xD;
&#xD;
        6. Has partial anomolous pulmonary venous drainage&#xD;
&#xD;
        7. Has pulmonary vascular resistance above 7 Woods units or a right-toleft shunt at the&#xD;
           atrial level with a peripheral arterial saturation less than 94%&#xD;
&#xD;
        8. Has a recent myocardial infarction, unstable angina and decompensated congestive heart&#xD;
           failure (CHF)&#xD;
&#xD;
        9. Has right and/or left ventricular decompensation with ejection fraction of &lt; 30%&#xD;
&#xD;
       10. Has an active bacterial and/or viral infection&#xD;
&#xD;
       11. Has any type of serious infection &lt; 1 month prior to the procedure&#xD;
&#xD;
       12. Has malignancy where life expectancy is &lt; 2 years&#xD;
&#xD;
       13. Has demonstrated intracardiac thrombi on echocardiography&#xD;
&#xD;
       14. Weighs &lt; 8 kg&#xD;
&#xD;
       15. Has gastritis, gastric ulcer, duodenal ulcer, etc. and other contraindications to&#xD;
           aspirin therapy unless other anti-platelet agents can be administered for 6 months&#xD;
&#xD;
       16. Has an unstable condition or otherwise thought to be unreliable or incapable of&#xD;
           complying with the requirements of the clinical investigational plan (CIP).&#xD;
&#xD;
       17. Has any disorder that, in the opinion of the Investigator, might interfere with the&#xD;
           conduct of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 21, 2012</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">December 23, 2015</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>This is a randomized, controlled, multi-centre trial of the efficacy and safety of the Occlutech septal occluder (Figulla Flex II) compared to the AGA septal occluder (Amplatzer ASO) for transcatheter closure of secundum atrial septal defects in patients.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy: the rate of a successful placement of the device</measure>
    <time_frame>the day after procedure but no later than 36 hours after the procedure.</time_frame>
    <description>The primary efficacy endpoint was early efficacy success rate, which was defined as the rate of a successful placement of the device, and successful closure of the defects without major complication, surgical reintervention, device embolization or moderate or large residual shunt the day after procedure but no later than 36 hours after the procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy:The secondary efficacy endpoint is the rate of closure success (residual shunt is smaller than or equal to 2 mm) within 6 months after the procedure, without the need for surgical repair.</measure>
    <time_frame>within 6 months after the procedure</time_frame>
    <description>The secondary efficacy endpoint is the rate of closure success (residual shunt is smaller than or equal to 2 mm) within 6 months after the procedure, without the need for surgical repair.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy:Other efficacy endpoint was the rate of complete closure (no residual shunt) at 6 months after the procedure.</measure>
    <time_frame>at 6 months after the procedure.</time_frame>
    <description>Other efficacy endpoint was the rate of complete closure (no residual shunt) at 6 months after the procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: Major, minor complications rate, all SAEs</measure>
    <time_frame>6 and 12 months post procedure</time_frame>
    <description>Major and complications rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Secundum Atrial Septal Defects</condition>
  <arm_group>
    <arm_group_label>Occlutech septal occluder ( Figulla Flex II)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Occlutech septal occluder (Figulla Flex II)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amplatzer Septal Occluder (ASO)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>St. Jude AGA septal occluder (Amplatzer ASO)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcatheter closure of secundum atrial septal defects in patients</intervention_name>
    <description>transcatheter closure of secundum atrial septal defects in patients</description>
    <arm_group_label>Amplatzer Septal Occluder (ASO)</arm_group_label>
    <arm_group_label>Occlutech septal occluder ( Figulla Flex II)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A patient will be eligible for study participation if he/she meets the following criteria:&#xD;
&#xD;
          1. Able to fluently speak and understand the language in which the study is being&#xD;
             conducted&#xD;
&#xD;
          2. Has ostium secundum atrial septal defect&#xD;
&#xD;
          3. Has a defect hole with a diameter of &lt; 38 mm&#xD;
&#xD;
          4. Has a left-to-right shunt with a Qp/Qs ratio of ≥ 1.5:1 or the presence of right&#xD;
             ventricular volume overload determined by transthoracic echo (TTE) or clinical&#xD;
             symptoms due to the atrial septal defect&#xD;
&#xD;
          5. Has a distance of &gt; 5 mm from the margins of the defect(s) to the coronary sinus,&#xD;
             arterioventricular (AV) valves and right upper pulmonary vein as measured by&#xD;
             echocardiography&#xD;
&#xD;
          6. Agrees to participate in the study and comply with the follow-up schedule&#xD;
&#xD;
          7. Is willing to freely give (or Legally Authorized Representative is willing to freely&#xD;
             give) Informed Consent prior to treatment&#xD;
&#xD;
          8. Willing to return for the post-treatment evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has multiple defects which can't adequately be covered by the device&#xD;
&#xD;
          2. Has associated congenital cardiac anomalies which require cardiac surgery&#xD;
&#xD;
             a. Has a known sensitivity to contrast media that cannot be controlled adequately with&#xD;
             pre-medication.&#xD;
&#xD;
          3. Patient is currently participating in another clinical device or drug trial that has&#xD;
             not completed its primary endpoint or that will clinically confound the current study&#xD;
             endpoints or does not permit subjects to participate in other studies. Typically,&#xD;
             subjects that are involved in the long-term surveillance phase of a clinical study are&#xD;
             eligible.&#xD;
&#xD;
          4. Has ostium primum atrial septal defects&#xD;
&#xD;
          5. Has sinus venosus atrial septal defects&#xD;
&#xD;
          6. Has partial anomolous pulmonary venous drainage&#xD;
&#xD;
          7. Has pulmonary vascular resistance above 7 Woods units or a right-toleft shunt at the&#xD;
             atrial level with a peripheral arterial saturation less than 94%&#xD;
&#xD;
          8. Has a recent myocardial infarction, unstable angina and decompensated congestive heart&#xD;
             failure (CHF)&#xD;
&#xD;
          9. Has right and/or left ventricular decompensation with ejection fraction of &lt; 30%&#xD;
&#xD;
         10. Has an active bacterial and/or viral infection&#xD;
&#xD;
         11. Has any type of serious infection &lt; 1 month prior to the procedure&#xD;
&#xD;
         12. Has malignancy where life expectancy is &lt; 2 years&#xD;
&#xD;
         13. Has demonstrated intracardiac thrombi on echocardiography&#xD;
&#xD;
         14. Weighs &lt; 8 kg&#xD;
&#xD;
         15. Has gastritis, gastric ulcer, duodenal ulcer, etc. and other contraindications to&#xD;
             aspirin therapy unless other anti-platelet agents can be administered for 6 months&#xD;
&#xD;
         16. Has an unstable condition or otherwise thought to be unreliable or incapable of&#xD;
             complying with the requirements of the clinical investigational plan (CIP).&#xD;
&#xD;
         17. Has any disorder that, in the opinion of the Investigator, might interfere with the&#xD;
             conduct of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Occlutech</keyword>
  <keyword>Transcatheter closure of secundum atrial septal defects</keyword>
  <keyword>Figulla Flex II</keyword>
  <keyword>Occ201201</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Septal Defects</mesh_term>
    <mesh_term>Heart Septal Defects, Atrial</mesh_term>
    <mesh_term>Foramen Ovale, Patent</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/NCT04488120
org study id: Occ201201
nct id: NCT04488120
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objectives of the study are:

        -  To determine the efficacy of the Figulla Flex II device compared with that of the
           Amplatzer ASO device for transcatheter closure of secundum atrial septal defects

        -  To determine the safety of the Figulla Flex II device compared with that of the
           Amplatzer ASO device for transcatheter closure of secundum atrial septal defects

      This is a randomized, controlled, multi-centre trial of the efficacy and safety of the
      Occlutech septal occluder (Figulla Flex II) compared to the AGA septal occluder (Amplatzer
      ASO) for transcatheter closure of secundum atrial septal defects in patients.
Inclusion criteria A patient will be eligible for study participation if he/she meets the
      following criteria:

        1. Able to fluently speak and understand the language in which the study is being conducted

        2. Has ostium secundum atrial septal defect

        3. Has a defect hole with a diameter of < 38 mm

        4. Has a left-to-right shunt with a Qp/Qs ratio of . 1.5:1 or the presence of right
           ventricular volume overload determined by transthoracic echo (TTE) or clinical symptoms
           due to the atrial septal defect

        5. Has a distance of > 5 mm from the margins of the defect(s) to the coronary sinus,
           arterioventricular (AV) valves and right upper pulmonary vein as measured by
           echocardiography

        6. Agrees to participate in the study and comply with the follow-up schedule

        7. Is willing to freely give (or Legally Authorized Representative is willing to freely
           give) Informed Consent prior to treatment

        8. Willing to return for the post-treatment evaluation. Exclusion criteria

      A patient will be excluded from the study if he/she meets the following criteria:

        1. Has multiple defects which can�ft adequately be covered by the device

        2. Has associated congenital cardiac anomalies which require cardiac surgery

           a. Has a known sensitivity to contrast media that cannot be controlled adequately with
           pre-medication.

        3. Patient is currently participating in another clinical device or drug trial that has not
           completed its primary endpoint or that will clinically confound the current study
           endpoints or does not permit subjects to participate in other studies. Typically,
           subjects that are involved in the long-term surveillance phase of a clinical study are
           eligible.

        4. Has ostium primum atrial septal defects

        5. Has sinus venosus atrial septal defects

        6. Has partial anomolous pulmonary venous drainage

        7. Has pulmonary vascular resistance above 7 Woods units or a right-toleft shunt at the
           atrial level with a peripheral arterial saturation less than 94%

        8. Has a recent myocardial infarction, unstable angina and decompensated congestive heart
           failure (CHF)

        9. Has right and/or left ventricular decompensation with ejection fraction of < 30%

       10. Has an active bacterial and/or viral infection

       11. Has any type of serious infection < 1 month prior to the procedure

       12. Has malignancy where life expectancy is < 2 years

       13. Has demonstrated intracardiac thrombi on echocardiography

       14. Weighs < 8 kg

       15. Has gastritis, gastric ulcer, duodenal ulcer, etc. and other contraindications to
           aspirin therapy unless other anti-platelet agents can be administered for 6 months

       16. Has an unstable condition or otherwise thought to be unreliable or incapable of
           complying with the requirements of the clinical investigational plan (CIP).

       17. Has any disorder that, in the opinion of the Investigator, might interfere with the
           conduct of the study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized, controlled, multi-centre trial of the efficacy and safety of the Occlutech septal occluder (Figulla Flex II) compared to the AGA septal occluder (Amplatzer ASO) for transcatheter closure of secundum atrial septal defects in patients.
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy: the rate of a successful placement of the device
time frame: the day after procedure but no later than 36 hours after the procedure.
description: The primary efficacy endpoint was early efficacy success rate, which was defined as the rate of a successful placement of the device, and successful closure of the defects without major complication, surgical reintervention, device embolization or moderate or large residual shunt the day after procedure but no later than 36 hours after the procedure.
measure: Efficacy:The secondary efficacy endpoint is the rate of closure success (residual shunt is smaller than or equal to 2 mm) within 6 months after the procedure, without the need for surgical repair.
time frame: within 6 months after the procedure
description: The secondary efficacy endpoint is the rate of closure success (residual shunt is smaller than or equal to 2 mm) within 6 months after the procedure, without the need for surgical repair.
measure: Efficacy:Other efficacy endpoint was the rate of complete closure (no residual shunt) at 6 months after the procedure.
time frame: at 6 months after the procedure.
description: Other efficacy endpoint was the rate of complete closure (no residual shunt) at 6 months after the procedure.
measure: Safety: Major, minor complications rate, all SAEs
time frame: 6 and 12 months post procedure
description: Major and complications rate
arm group label: Occlutech septal occluder ( Figulla Flex II)
arm group type: Experimental
description: Occlutech septal occluder (Figulla Flex II)
arm group label: Amplatzer Septal Occluder (ASO)
arm group type: Active Comparator
description: St. Jude AGA septal occluder (Amplatzer ASO)
intervention type: Device
intervention name: transcatheter closure of secundum atrial septal defects in patients
description: transcatheter closure of secundum atrial septal defects in patients
arm group label: Amplatzer Septal Occluder (ASO)
arm group label: Occlutech septal occluder ( Figulla Flex II)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Heart Septal Defects
mesh term: Heart Septal Defects, Atrial
mesh term: Foramen Ovale, Patent
sharing ipd: Undecided