<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/NCT04415047</url>
  </required_header>
  <id_info>
    <org_study_id>P02C320</org_study_id>
    <nct_id>NCT04415047</nct_id>
  </id_info>
  <brief_title>The JenaValve ALIGN-AR Pivotal Trial</brief_title>
  <acronym>ALIGN-AR</acronym>
  <official_title>A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JenaValve Technology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>JenaValve Technology, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To collect information about treatment for symptomatic severe Aortic Regurgitation (AR),&#xD;
      which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic&#xD;
      valve in the heart does not close tightly and allows some blood to leak back into the heart&#xD;
      chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The&#xD;
      preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a&#xD;
      minimally invasive procedure designed to replace the aortic valve inside the heart. In this&#xD;
      study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended&#xD;
      to help treat symptomatic severe aortic regurgitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 22, 2020</start_date>
  <completion_date type="Anticipated">August 2028</completion_date>
  <primary_completion_date type="Anticipated">August 29, 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>All-Cause Mortality at 1 Year</measure>
    <time_frame>1 year</time_frame>
    <description>All-cause mortality within the first 12 months post index procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All Stroke</measure>
    <time_frame>30 days</time_frame>
    <description>Number of patients that had a stroke</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Major Bleeding</measure>
    <time_frame>30 days</time_frame>
    <description>Number of patients that had any of these events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute Kidney Injury</measure>
    <time_frame>30 days</time_frame>
    <description>Number of patients that had these events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Major Vascular Complications</measure>
    <time_frame>30 days</time_frame>
    <description>Number of patients that had these events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgery/intervention related to the device</measure>
    <time_frame>30 days</time_frame>
    <description>Number of patients that had these events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Permanent pacemaker implantation</measure>
    <time_frame>30 days</time_frame>
    <description>Number of patients that had these events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total aortic regurgitation</measure>
    <time_frame>30 days</time_frame>
    <description>Number of patients that had these events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>KCCQ</measure>
    <time_frame>1 year</time_frame>
    <description>KCCQ Improvement</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Aortic Regurgitation</condition>
  <condition>Aortic Valve Insufficiency</condition>
  <condition>Aortic Insufficiency</condition>
  <condition>Aortic Valve Disease</condition>
  <arm_group>
    <arm_group_label>Transcatheter Aortic Valve Replacement (TAVR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>JenaValve Trilogy Heart Valve System</intervention_name>
    <description>TAVR with JenaValve Trilogy Heart Valve System</description>
    <arm_group_label>Transcatheter Aortic Valve Replacement (TAVR)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with severe aortic regurgitation (AR).&#xD;
&#xD;
          -  Patient at high risk for open surgical valve replacement&#xD;
&#xD;
          -  Patient symptomatic according to NYHA functional class II or higher&#xD;
&#xD;
          -  The study patient has been informed of the nature of the study, agrees to its&#xD;
             provisions and has provided written informed consent as approved by the Institutional&#xD;
             Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital uni or bicuspid aortic valve morphology&#xD;
&#xD;
          -  Previous prosthetic aortic valve (bioprosthesis or mechanical) implant&#xD;
&#xD;
          -  Endocarditis or other active infection&#xD;
&#xD;
          -  Need for urgent or emergent TAVR procedure for any reason&#xD;
&#xD;
          -  Cardiogenic shock or hemodynamic instability requiring inotropic support or&#xD;
             ventricular assist device&#xD;
&#xD;
          -  Severe mitral regurgitation&#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>Martin B. Leon, MD</last_name>
    <role>Study Chair</role>
    <affiliation>New York-Presbyterian/ Columbia University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Torsten P. Vahl, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York-Presbyterian/ Columbia University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vinod H. Thourani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Piedmont Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TMC HealthCare &amp; PIMA Heart</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center Research Institute</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morton Plant/ BayCare Health</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Healthcare</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Heart Institute/ Abbott Northwestern</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnes-Jewish Hospital / Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital</name>
      <address>
        <city>Piscataway</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York-Presbyterian/ Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Health Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny-Singer Health Network</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Le Bonheur Healthcare</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann - Texas Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center Heart Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Hospitals</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.</citation>
    <PMID>28314623</PMID>
  </reference>
  <reference>
    <citation>Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Jun 20;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503. Epub 2017 Mar 15. No abstract available.</citation>
    <PMID>28298458</PMID>
  </reference>
  <reference>
    <citation>Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.</citation>
    <PMID>12831818</PMID>
  </reference>
  <reference>
    <citation>Geyer M, Tamm AR, Munzel T, Treede H, von Bardeleben RS. Novel Transfemoral TAVR System to Treat Aortic Regurgitation in Degenerated Surgical Aortic Valve Replacement Even in Unfavorable Anatomy. JACC Cardiovasc Interv. 2022 Jun 13;15(11):e135-e136. doi: 10.1016/j.jcin.2022.02.043. Epub 2022 May 11. No abstract available.</citation>
    <PMID>35568645</PMID>
  </reference>
  <reference>
    <citation>Poschner T, Werner P, Kocher A, Laufer G, Musumeci F, Andreas M, Russo M. The JenaValve pericardial transcatheter aortic valve replacement system to treat aortic valve disease. Future Cardiol. 2022 Feb;18(2):101-113. doi: 10.2217/fca-2021-0065. Epub 2021 Oct 14.</citation>
    <PMID>34647465</PMID>
  </reference>
  <reference>
    <citation>Ng VG, Khalique OK, Nazif T, Patel A, Hamid N, George I, Bapat V, Hahn R, Kodali S, Vahl TP. Treatment of Acute Aortic Insufficiency With a Dedicated Device. JACC Case Rep. 2021 Mar 24;3(4):645-649. doi: 10.1016/j.jaccas.2021.01.021. eCollection 2021 Apr.</citation>
    <PMID>34317595</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>September 7, 2022</last_update_submitted>
  <last_update_submitted_qc>September 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Valvular Heart Disease</keyword>
  <keyword>Aortic Incompetence</keyword>
  <keyword>Aortic Valve Incompetence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Disease</mesh_term>
    <mesh_term>Aortic Valve Insufficiency</mesh_term>
  </condition_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/NCT04415047
org study id: P02C320
nct id: NCT04415047
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR),
      which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic
      valve in the heart does not close tightly and allows some blood to leak back into the heart
      chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The
      preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a
      minimally invasive procedure designed to replace the aortic valve inside the heart. In this
      study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended
      to help treat symptomatic severe aortic regurgitation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-Cause Mortality at 1 Year
time frame: 1 year
description: All-cause mortality within the first 12 months post index procedure
measure: All Stroke
time frame: 30 days
description: Number of patients that had a stroke
measure: Major Bleeding
time frame: 30 days
description: Number of patients that had any of these events
measure: Acute Kidney Injury
time frame: 30 days
description: Number of patients that had these events
measure: Major Vascular Complications
time frame: 30 days
description: Number of patients that had these events
measure: Surgery/intervention related to the device
time frame: 30 days
description: Number of patients that had these events
measure: Permanent pacemaker implantation
time frame: 30 days
description: Number of patients that had these events
measure: Total aortic regurgitation
time frame: 30 days
description: Number of patients that had these events
measure: KCCQ
time frame: 1 year
description: KCCQ Improvement
arm group label: Transcatheter Aortic Valve Replacement (TAVR)
arm group type: Experimental
description: TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System
intervention type: Device
intervention name: JenaValve Trilogy Heart Valve System
description: TAVR with JenaValve Trilogy Heart Valve System
arm group label: Transcatheter Aortic Valve Replacement (TAVR)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin B. Leon, MD
role: Study Chair
affiliation: New York-Presbyterian/ Columbia University Medical Center
last name: Torsten P. Vahl, MD
role: Principal Investigator
affiliation: New York-Presbyterian/ Columbia University Medical Center
last name: Vinod H. Thourani, MD
role: Principal Investigator
affiliation: Piedmont Healthcare
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country: United States
citation: Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.
PMID: 28314623
citation: Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Jun 20;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503. Epub 2017 Mar 15. No abstract available.
PMID: 28298458
citation: Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.
PMID: 12831818
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PMID: 35568645
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PMID: 34647465
citation: Ng VG, Khalique OK, Nazif T, Patel A, Hamid N, George I, Bapat V, Hahn R, Kodali S, Vahl TP. Treatment of Acute Aortic Insufficiency With a Dedicated Device. JACC Case Rep. 2021 Mar 24;3(4):645-649. doi: 10.1016/j.jaccas.2021.01.021. eCollection 2021 Apr.
PMID: 34317595
responsible party type: Sponsor
mesh term: Aortic Valve Disease
mesh term: Aortic Valve Insufficiency
sharing ipd: No