<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/NCT03022851</url>
  </required_header>
  <id_info>
    <org_study_id>Occ2016_04</org_study_id>
    <secondary_id>CIV-16-07-016324</secondary_id>
    <nct_id>NCT03022851</nct_id>
  </id_info>
  <brief_title>The Prophet Trial -Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension</brief_title>
  <acronym>AFR-Prophet</acronym>
  <official_title>Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients With Pulmonary Hypertension</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with&#xD;
      severe pulmonary hypertension (PH).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will enroll subjects with severe pulmonary hypertension until a maximum of 30&#xD;
      patients have undergone implantation with the Occlutech® AFR device. Enrolment will be&#xD;
      devided in 2 phases.&#xD;
&#xD;
      Phase 1: At least 15 adult patients with age ≥ 18 years will be enrolled. Phase 2: Patients&#xD;
      with age ≥ 6 years will be enrolled until a maximum of 30 patients is reached.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 19, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">February 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absence of Serious Adverse Device Effects (SADES) within 3 month following implantation, including deaths, systemic embolism or device embolizations.</measure>
    <time_frame>0-3 month</time_frame>
    <description>To evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs between 3-12 months following implantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of all Serious Adverse Events (SAE) and (Serious) Adverse Device Effects (S)ADEs between 3-12 month post implantation</measure>
    <time_frame>3-12 month</time_frame>
    <description>To evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs between 3-12 months following implantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence of a secure placement of the device and of right-to-left shunt through the AFR device immediately after implantation and 3 month and 12 month after procedure.</measure>
    <time_frame>0-12 month</time_frame>
    <description>The secondary efficacy endpoint will be determined via assessment by color-doppler echocardiography and angiography/fluoroscopy and requires both of:&#xD;
Device placed in situ [as assessed by the investigator] Evidence of RIGHT TO LEFT shunt through the AFR device [as assessed by the investigator]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in number of syncopal events due to pulmonary hypertension in the 3 month, 6 months and 12 month after implantation</measure>
    <time_frame>0-12 month</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>Occlutech AFR Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who will get the AFR Device implantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Occlutech AFR Device</intervention_name>
    <description>Catheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure.</description>
    <arm_group_label>Occlutech AFR Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age is ≥ 18 / ≥6 years (phase 1 / phase 2).&#xD;
&#xD;
          2. Patient consents to participation&#xD;
&#xD;
          3. The patient or his/her legal representative should have the ability to fluently speak&#xD;
             and under-stand the language in which the study is being conducted. If the patient&#xD;
             speaks a different language, then a sentence-to-sentence translation for unequivocal&#xD;
             understanding must be provided.&#xD;
&#xD;
          4. Written, informed consent by the patient or her/his legally-authorized representative&#xD;
             for participation in the study.&#xD;
&#xD;
          5. Patient agrees to comply with the follow-up schedule.&#xD;
&#xD;
          6. Patient has had a successful BAS procedure and is in a stable hemodynamic state, as&#xD;
             assessed by the investigator.&#xD;
&#xD;
          7. Conventional treatment options for the patient are exhausted according to ESC and AHA&#xD;
             guidelines.&#xD;
&#xD;
          8. SpO2&gt; 86 % pulsoxymetric measurement) This document is confidential and property of&#xD;
             Occlutech. It´s only for clinical personnel, Ethical committees and third person in&#xD;
             direct contact with the clinical responsible. It is not allowed to distribute&#xD;
             information contained in this document without the permission of Occlutech unless the&#xD;
             information is already published.&#xD;
&#xD;
          9. &quot;Syncope&quot;(Group A-PH) 9.1. Syncope due to acute PH episodes (as defined by exclusion&#xD;
             of other causes) 9.2. Other causes of syncope must have been actively excluded 9.3.&#xD;
             Syncope (Black-out) or pre-syncope (episodic dizziness) &gt;2 last 3 months 9.4. PH&#xD;
             (defined as mean pulmonary artery pressure &gt; 25 mmHg, or pulmonary vascular resistance&#xD;
             of &gt; 3 Wood Units) must exist, RV-failure is however not a prerequisite&#xD;
&#xD;
         10. &quot;RV-Failure&quot;(Group B-PH) 10.1. Right heart failure, chronic and clinically severe&#xD;
             10.1.1.NYHA class III or worse 10.1.2. 6 min walk &lt; 320 m 10.1.3. Signs of venous&#xD;
             congestion (distended veins, edema, ascites, etc) 10.1.4.Symptomatic disease resulting&#xD;
             in 1 or more PH-related hospitalization over the last 12 months. Elective hospital&#xD;
             admissions solely for the purpose of performing diagnostic procedures do not count for&#xD;
             this.&#xD;
&#xD;
        10.2. Severe pulmonary hypertension as evident by echocardiography Echocardiographic:&#xD;
        10.2.1. RV larger than LV; 10.2.2. RA larger than LA; 10.2.3. atrial septum bulging into&#xD;
        left atrium 10.2.4.ventricular septum bulging into the left ventricle 10.2.5.Reduced (below&#xD;
        age-related normal mean value) TAPSE 10.3. Severe pulmonary hypertension as evident by CATH&#xD;
        CATH-data: 10.3.1.Mean RA pressure (RAP) of &gt; 10 and ≤ 20 mmHg; 10.3.2.Mean LA pressure&#xD;
        (LAP) &lt; 15 mmHg 10.3.3.Mean RAP &gt; mean LAP; 10.3.4.Mean pulmonary arterial pressure &gt;25 mm&#xD;
        Hg 10.3.5. Echocardiographically demonstrated continuous right to left shunt following&#xD;
        balloon aterial septostomy (BAS) and before AFR device implantation.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Processes which interfere medically with invasive device implantation&#xD;
&#xD;
          1. Local or generalized sepsis or other acute infection(s)&#xD;
&#xD;
          2. Thrombophilic coagulation disorder&#xD;
&#xD;
          3. Allergy to nickel and/or titanium and/or nickel/titanium-based materials&#xD;
&#xD;
          4. Allergy to anti-platelet, -coagulant, or -thrombotic therapy&#xD;
&#xD;
          5. Intolerance to contrast agents&#xD;
&#xD;
          6. Participation in other medical trials shorter than 30 days before the intended AFR&#xD;
             implantation procedure&#xD;
&#xD;
          7. Pregnancy - (assessed in patients with child bearing potential by urine dip stick)&#xD;
&#xD;
          8. Any intracardiac intervention within the last 30 days&#xD;
&#xD;
          9. Thickness of atrial septum &gt; 12mm OR Processes which would technically disturb the&#xD;
             safe intervention as planned&#xD;
&#xD;
        1. Occluded inferior vena cava access 2. Previous ASD/PFO closure device in place 3.&#xD;
        Intracardiac thrombus OR any other circumstance that, in the opinion of the Investigator,&#xD;
&#xD;
        might interfere with the implantation, might affect the patient's well-being thereafter or&#xD;
        might interfere with the conduct and follow up within the Study is general.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Local or generalized sepsis or other acute infection(s)&#xD;
&#xD;
          -  Thrombophilic coagulation disorder&#xD;
&#xD;
          -  Allergy to nickel and/or titanium and/or nickel/titanium-based materials&#xD;
&#xD;
          -  Allergy to anti-platelet, -coagulant, or -thrombotic therapy&#xD;
&#xD;
          -  Intolerance to contrast agents&#xD;
&#xD;
          -  Participation in other medical trials shorter than 30 days before the intended AFR&#xD;
             implantation procedure&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any intracardiac intervention within the last 30 days&#xD;
&#xD;
          -  Occluded inferior vena cava access&#xD;
&#xD;
          -  Previous ASD/PFO closure device in place&#xD;
&#xD;
          -  Intracardiac thrombus&#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_contact>
    <last_name>Gönül Sönmez Utkun</last_name>
    <phone>+902124650497</phone>
    <email>clinicaltrials@occlutech.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Klinikum der Universität München</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nikolaus Haas, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Elisabeth Krankenhaus</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Justus-Liebig Universität</name>
      <address>
        <city>Giesen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Jux, MD</last_name>
      <phone>+49 (0) 641/985-43461</phone>
      <email>christian.jux@paediat.med.uni-giessen.de</email>
    </contact>
    <investigator>
      <last_name>Christian Jux, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg</name>
      <address>
        <city>Würzburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Nordbeck, MD</last_name>
      <phone>+49 (0)-931 201-39004</phone>
      <email>Nordbeck_P@ukw.de</email>
    </contact>
    <investigator>
      <last_name>Peter Nordbeck, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>R. M. Berger, MD</last_name>
      <phone>+31 (0) 50 361 2800</phone>
      <email>r.m.f.berger@umcg.nl</email>
    </contact>
    <investigator>
      <last_name>R. M. Berger, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martijn C. Post, MD</last_name>
      <phone>+31 30 6099111</phone>
      <email>m.post@antoniusziekenhuis.nl</email>
    </contact>
    <investigator>
      <last_name>Martijn C. Post, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gdański Uniwersytet Medyczny</name>
      <address>
        <city>Gdańsk</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Sabiniewicz, MD</last_name>
      <phone>‭+48 695 687 587‬</phone>
      <email>sabini@gumed.edu.pl</email>
    </contact>
    <investigator>
      <last_name>Robert Sabiniewicz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Uniwersytet Jagielloński Collegium Medicum</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grzegorz Kopeć, MD</last_name>
      <phone>+48 12 614 33 99</phone>
      <email>grzegorzkrakow1@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Grzegorz Kopeć Kopeć, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Szpital im. Fryderyka Chopina</name>
      <address>
        <city>Otwock</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcin Kuzyna, MD</last_name>
      <phone>+48-22-7103052</phone>
      <email>marcin.kurzyna@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Marcin Kurzyna, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego</name>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maciej Lesiak, MD</last_name>
      <phone>+48 61 854 91 46</phone>
      <email>maciej.lesiak@skpp.edu.pl</email>
    </contact>
    <investigator>
      <last_name>Maciej Lesiak, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hacettepe Üniversitesi Tıp Fakültesi</name>
      <address>
        <city>Altındağ</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ergün Barış Kaya, MD</last_name>
      <phone>+90 533 778 72 60</phone>
      <email>doctorkaya@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Ergün Barış Kaya, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ankara Dışkapı Yıldırım Beyazıt Hastanesi</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hakan Güllü, MD</last_name>
      <phone>+90 5320521426</phone>
      <email>drgullu@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Hakan Güllü, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ege Üniversitesi Tıp Fakültesi Hastanesi</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sağlık Bilimleri Üniversitesi Tepecik Eğitim ve Araştırma Hastanesi</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barış Kılıçaslan, MD</last_name>
      <phone>+90 505 588 81 88</phone>
      <email>kilicaslan@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Barış Kılıçaslan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kocaeli Üniversitesi Araştırma ve Uygulama Hastanesi</name>
      <address>
        <city>Kocaeli</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Teoman Kılıç, MD</last_name>
      <phone>+90 (0) 262303 7335</phone>
      <email>teoman.kilic@kocaeli.edu.tr</email>
    </contact>
    <investigator>
      <last_name>Teoman Kılıç, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sivas Cumhuriyet Üniversitesi Tıp Fakültesi</name>
      <address>
        <city>Sivas</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>September 5, 2022</last_update_submitted>
  <last_update_submitted_qc>September 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2022</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>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT03022851
org study id: Occ2016_04
secondary id: CIV-16-07-016324
nct id: NCT03022851
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate safety and efficacy of Occlutech® AFR device in patients with
      severe pulmonary hypertension (PH).
This study will enroll subjects with severe pulmonary hypertension until a maximum of 30
      patients have undergone implantation with the Occlutech® AFR device. Enrolment will be
      devided in 2 phases.

      Phase 1: At least 15 adult patients with age ≥ 18 years will be enrolled. Phase 2: Patients
      with age ≥ 6 years will be enrolled until a maximum of 30 patients is reached.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Absence of Serious Adverse Device Effects (SADES) within 3 month following implantation, including deaths, systemic embolism or device embolizations.
time frame: 0-3 month
description: To evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs between 3-12 months following implantation.
measure: Rate of all Serious Adverse Events (SAE) and (Serious) Adverse Device Effects (S)ADEs between 3-12 month post implantation
time frame: 3-12 month
description: To evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs between 3-12 months following implantation.
measure: Evidence of a secure placement of the device and of right-to-left shunt through the AFR device immediately after implantation and 3 month and 12 month after procedure.
time frame: 0-12 month
description: The secondary efficacy endpoint will be determined via assessment by color-doppler echocardiography and angiography/fluoroscopy and requires both of:
Device placed in situ [as assessed by the investigator] Evidence of RIGHT TO LEFT shunt through the AFR device [as assessed by the investigator]
measure: Improvement in number of syncopal events due to pulmonary hypertension in the 3 month, 6 months and 12 month after implantation
time frame: 0-12 month
arm group label: Occlutech AFR Device
arm group type: Experimental
description: Patients who will get the AFR Device implantation
intervention type: Device
intervention name: Occlutech AFR Device
description: Catheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure.
arm group label: Occlutech AFR Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gönül Sönmez Utkun
phone: +902124650497
email: clinicaltrials@occlutech.com
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
country: Germany
country: Netherlands
country: Poland
country: Turkey
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hypertension