<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/NCT04436653</url>
  </required_header>
  <id_info>
    <org_study_id>TRAVEL</org_study_id>
    <nct_id>NCT04436653</nct_id>
  </id_info>
  <brief_title>THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve</brief_title>
  <acronym>TRAVEL</acronym>
  <official_title>THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fu Wai Hospital, Beijing, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Anzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Changhai Hospital</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>
      The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid&#xD;
      valve and delivery system which are intended to use in symptomatic patients with severe&#xD;
      tricuspid regurgitation and high surgical risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The TRAVEL study is a prospective multi-center single-arm trial for transcatheter tricuspid&#xD;
      valve replacement with LuX-Valve. A series of physical, imaging and laboratory exams will be&#xD;
      performed to determine whether a subject has severe tricuspid regurgitation with high&#xD;
      surgical risk. Subjects who meet the criteria will then receive LuX-Valve implantation if an&#xD;
      informed consent is obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">June 2026</completion_date>
  <primary_completion_date type="Anticipated">June 2026</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>
    <intervention_model_description>This is a prospective, multi-center single-arm trial in seven centers in China. A minimum of 150 subjects will be enrolled in this study and followed-up at discharge (≤ 10 days post operation), 30 days, 6 months, 1, 2, 3, 4, 5 years.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>1 Year</time_frame>
    <description>All-cause Death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tricuspid Regurgitation Reduction</measure>
    <time_frame>1 Year</time_frame>
    <description>Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device or Procedure-Related Adverse Events</measure>
    <time_frame>1 Year</time_frame>
    <description>Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device or Procedure-Related Adverse Events</measure>
    <time_frame>2 Year</time_frame>
    <description>Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device or Procedure-Related Adverse Events</measure>
    <time_frame>3 Year</time_frame>
    <description>Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device or Procedure-Related Adverse Events</measure>
    <time_frame>4 Year</time_frame>
    <description>Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device or Procedure-Related Adverse Events</measure>
    <time_frame>5 Year</time_frame>
    <description>Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Event (MAE)</measure>
    <time_frame>1 Year</time_frame>
    <description>MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Event (MAE)</measure>
    <time_frame>2 Year</time_frame>
    <description>MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Event (MAE)</measure>
    <time_frame>3 Year</time_frame>
    <description>MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Event (MAE)</measure>
    <time_frame>4 Year</time_frame>
    <description>MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Event (MAE)</measure>
    <time_frame>5 Year</time_frame>
    <description>MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Change in New York Heart Association (NYHA) Classification</measure>
    <time_frame>1 Year</time_frame>
    <description>Subjects' heart function is ranged from NYHA I to IV based on how much a patient is limited during physical activity. NYHA I means no limited on physical activity while NYHA IV means unable to take any physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life (QOL) is evaluated with Kansas City Cardiomyopathy (KCCQ)</measure>
    <time_frame>1 Year</time_frame>
    <description>KCCQ score ranges from 0 to 100, which 0 reflects the worst health status and 100 reflects the best health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life (QOL) is evaluated with Six Minute Walk Test (6MWT)</measure>
    <time_frame>1 Year</time_frame>
    <description>6MWT distance is recorded and compared with baseline during follow-up.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Tricuspid Valve Insufficiency</condition>
  <arm_group>
    <arm_group_label>Tricuspid Valve Replacement System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system will be included in this arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tricuspid Valve Replacement System</intervention_name>
    <description>To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system.</description>
    <arm_group_label>Tricuspid Valve Replacement System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 50 years at time of consent.&#xD;
&#xD;
          2. Subjects or subject's legal representative has been informed of the nature of the&#xD;
             study and provided written informed consent.&#xD;
&#xD;
          3. The site heart team confirmed the subject is at high risk for tricuspid valve surgery&#xD;
             (euroSCORE II ≥ 7.0%) and the subject will get benefit from the intervention.&#xD;
&#xD;
          4. Subjects must guarantee they won't participate in any other clinical trial for a&#xD;
             period of one year after the intervention.&#xD;
&#xD;
          5. Subjects are with New York Heart Association (NYHA) Functional Class III or IV.&#xD;
&#xD;
          6. Subjects are with normal left heart function (EF ≥ 50%).&#xD;
&#xD;
          7. No indications for left-sided or pulmonary valve intervention.&#xD;
&#xD;
          8. Subjects must have severe or greater tricuspid regurgitation ( the vena contracta (VC)&#xD;
             width ≥ 7 mm or the effective regurgitant orifice area (EROA) ≥ 40 mm2), which&#xD;
             confirmed by the Echocardiography Core Lab (ECL) via transthoracic echocardiogram&#xD;
             (TTE).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with pulmonary hypertension (systolic pressure ≥ 55mmHg determined by right&#xD;
             heart catheterization).&#xD;
&#xD;
          2. Subjects with previous transcatheter or surgical tricuspid valve procedure.&#xD;
&#xD;
          3. Subjects with tricuspid stenosis or other anatomy disorders that unsuitable for the&#xD;
             procedure.&#xD;
&#xD;
          4. Subjects with depressed right heart function (tricuspid annular plane systolic&#xD;
             excursion (TAPSE) &lt; 10mm or right ventricle fractional area change (FAC) &lt; 20%).&#xD;
&#xD;
          5. Subjects with aortic stenosis (mean ΔP≥ 40mmHg or aortic valve area ≤ 1 cm2), aortic&#xD;
             regurgitation (≥ 3+), mitral stenosis (mitral valve area ≤1.5 cm2) or mitral&#xD;
             regurgitation (≥ 3+).&#xD;
&#xD;
          6. Subjects with active endocarditis or other infectious diseases.&#xD;
&#xD;
          7. Subjects with untreated severe coronary artery disease.&#xD;
&#xD;
          8. Subjects with percutaneous coronary intervention, cerebrovascular accident or surgical&#xD;
             intervention within 3 months of the date of the procedure.&#xD;
&#xD;
          9. Subjects with coagulation disorders.&#xD;
&#xD;
         10. Subjects with known allergy, hypersensitivity or contraindication to the material or&#xD;
             drugs used in the procedure.&#xD;
&#xD;
         11. Subjects with cognitive disorders that can not cooperate the study or follow-up.&#xD;
&#xD;
         12. Subjects with less than 12 months life expectancy because of non-cardiac conditions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhiyun Xu, MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhai Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shengshou Hu, MD.</last_name>
    <role>Study Chair</role>
    <affiliation>Fu Wai Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fanglin Lu, MD.</last_name>
    <role>Study Director</role>
    <affiliation>Changhai Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhao An, MD.</last_name>
    <phone>+8613761420325</phone>
    <email>anzhao1@yeah.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fan Qiao, MD.</last_name>
    <phone>+8613564620805</phone>
    <email>qiaofan@smmu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xu Meng, MD.</last_name>
      <phone>010-64456260</phone>
      <email>mxu@263.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fu Wai Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangbin Pan, MD.</last_name>
      <phone>010-68314466</phone>
      <email>xiangbin428@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huiming Guo, MD.</last_name>
      <email>guohuiming@vip.tom.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wuhan Union Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nianguo Dong, MD.</last_name>
      <email>ng_dong@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian Yang, MD.</last_name>
      <email>yangjian1212@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Shiqiang Yu, MD.</last_name>
      <email>yushiq@fmmu.edu.cn</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhiyun Xu, MD.</last_name>
      <phone>021-31166666</phone>
      <email>zhiyunx@smmu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>West China Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yingqiang Guo, MD.</last_name>
      <phone>+86 028 85421833</phone>
    </contact>
    <contact_backup>
      <last_name>Mao Chen, MD.</last_name>
      <email>hmaochen@vip.sina.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianan Wang, MD.</last_name>
      <email>wangjianan111@zju.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Zhiyun Xu</investigator_full_name>
    <investigator_title>Chair of Department of Cardiovascular Surgery</investigator_title>
  </responsible_party>
  <keyword>Tricuspid Regurgitation</keyword>
  <keyword>LuX-Valve</keyword>
  <keyword>Transcatheter Valve Replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tricuspid 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/NCT04436653
org study id: TRAVEL
nct id: NCT04436653
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid
      valve and delivery system which are intended to use in symptomatic patients with severe
      tricuspid regurgitation and high surgical risk.
The TRAVEL study is a prospective multi-center single-arm trial for transcatheter tricuspid
      valve replacement with LuX-Valve. A series of physical, imaging and laboratory exams will be
      performed to determine whether a subject has severe tricuspid regurgitation with high
      surgical risk. Subjects who meet the criteria will then receive LuX-Valve implantation if an
      informed consent is obtained.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a prospective, multi-center single-arm trial in seven centers in China. A minimum of 150 subjects will be enrolled in this study and followed-up at discharge (≤ 10 days post operation), 30 days, 6 months, 1, 2, 3, 4, 5 years.
primary purpose: Treatment
masking: None (Open Label)
measure: Death
time frame: 1 Year
description: All-cause Death
measure: Tricuspid Regurgitation Reduction
time frame: 1 Year
description: Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.
measure: Device or Procedure-Related Adverse Events
time frame: 1 Year
description: Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
measure: Device or Procedure-Related Adverse Events
time frame: 2 Year
description: Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
measure: Device or Procedure-Related Adverse Events
time frame: 3 Year
description: Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
measure: Device or Procedure-Related Adverse Events
time frame: 4 Year
description: Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
measure: Device or Procedure-Related Adverse Events
time frame: 5 Year
description: Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
measure: Major Adverse Event (MAE)
time frame: 1 Year
description: MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
measure: Major Adverse Event (MAE)
time frame: 2 Year
description: MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
measure: Major Adverse Event (MAE)
time frame: 3 Year
description: MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
measure: Major Adverse Event (MAE)
time frame: 4 Year
description: MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
measure: Major Adverse Event (MAE)
time frame: 5 Year
description: MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
measure: Functional Change in New York Heart Association (NYHA) Classification
time frame: 1 Year
description: Subjects' heart function is ranged from NYHA I to IV based on how much a patient is limited during physical activity. NYHA I means no limited on physical activity while NYHA IV means unable to take any physical activity.
measure: Change in Quality of Life (QOL) is evaluated with Kansas City Cardiomyopathy (KCCQ)
time frame: 1 Year
description: KCCQ score ranges from 0 to 100, which 0 reflects the worst health status and 100 reflects the best health status.
measure: Change in Quality of Life (QOL) is evaluated with Six Minute Walk Test (6MWT)
time frame: 1 Year
description: 6MWT distance is recorded and compared with baseline during follow-up.
arm group label: Tricuspid Valve Replacement System
arm group type: Experimental
description: Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system will be included in this arm.
intervention type: Device
intervention name: Tricuspid Valve Replacement System
description: To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system.
arm group label: Tricuspid Valve Replacement System
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Zhiyun Xu, MD.
role: Principal Investigator
affiliation: Changhai Hospital
last name: Shengshou Hu, MD.
role: Study Chair
affiliation: Fu Wai Hospital
last name: Fanglin Lu, MD.
role: Study Director
affiliation: Changhai Hospital
last name: Zhao An, MD.
phone: +8613761420325
email: anzhao1@yeah.net
last name: Fan Qiao, MD.
phone: +8613564620805
email: qiaofan@smmu.edu.cn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: Zhiyun Xu
investigator title: Chair of Department of Cardiovascular Surgery
mesh term: Tricuspid Valve Insufficiency
sharing ipd: No