<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/NCT04414358</url>
  </required_header>
  <id_info>
    <org_study_id>2020-3</org_study_id>
    <nct_id>NCT04414358</nct_id>
  </id_info>
  <brief_title>Incidence of Residual Tricuspid Regurgitation in Patients Undergoing Left-heart Surgery</brief_title>
  <official_title>Incidence of Residual Significant Tricuspid Regurgitation in Patients Undergoing Left-sided Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</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>
      Functional tricuspid valve regurgitation is commonly co-existed with left-sided cardiac&#xD;
      lesion, especially mitral valve stenosis. Both lesion were recommended to surgically fixed at&#xD;
      the same setting. Residual tricuspid regurgitation may effects patients' outcome. The&#xD;
      investigators would like to determine the incidence of significant residual tricuspid&#xD;
      regurgitation after left-sided cardiac surgery and related clinical outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Functional tricuspid regurgitation (TR) was defined as TR occurring secondary to left heart,&#xD;
      especially mitral valve stenosis or pulmonary disease. Previous study reported that about 30%&#xD;
      - 50% of patients with significant mitral stenosis developed moderate to severe TR. In the&#xD;
      past, corrective TR repair was not always indicated because the concept about TR severity&#xD;
      will improve after mitral valve lesion was treated.&#xD;
&#xD;
      Later on, several studies demonstrated that the patients with untreated significant (&lt;&#xD;
      moderate) TR had worse clinical outcome including mortality. While simultaneous functional TR&#xD;
      repair with left-sided valve surgery did not cause adverse events, but improve clinical&#xD;
      outcome and quality of life. The current European Society of Cardiology (ESC)/European&#xD;
      Association for Cardio-Thoracic Surgery (EACTS) and American Heart Association(AHA)/American&#xD;
      College of Cardiology (ACC) guidelines recommend concomitant tricuspid valve (TV) surgery in&#xD;
      patients with severe TR undergoing left-sided valve surgery (class I recommendation). In&#xD;
      patients with mild to moderate TR, there is a class IIa indication for concomitant TV surgery&#xD;
      in the setting of tricuspid annular dilatation.&#xD;
&#xD;
      However, after TV repair, commonly with annuloplasty ring or De Vega annuloplasty, residual&#xD;
      TR may still persist and the residual moderate or severe TR have negative impact to right&#xD;
      ventricle (RV). It can cause RV dilatation and RV failure(7, 12). Calafiore et al reported&#xD;
      12.4% of significant TR after surgery and the associated factors for the repair failure. If&#xD;
      this group of patients developed symptom of RV failure or progressive RV dilatation or&#xD;
      dysfunction is detected, they possessed very high-risk for re-operation.&#xD;
&#xD;
      Preoperative transthoracic echocardiography (TTE) is an important tool to classified severity&#xD;
      of TR, measured TV annulus, indicate the surgical correction requirement and demonstrate the&#xD;
      result of the TR repair. Due to limitation of TTE operator and machine, time-interval between&#xD;
      the latest preoperative TTE result and surgery are varied, so the TR severity may already&#xD;
      changed. The postoperative TTE result sometimes comes out late after surgery. Therefore,&#xD;
      transesophageal echocardiography (TEE), operated by trained cardiac anesthesiologist, may&#xD;
      play role to confirm the severity and provide the instant result of the TV repair to help&#xD;
      guide the cardiac surgeon to make a decision whether to re-operate in the same setting to&#xD;
      improve the surgical outcome.&#xD;
&#xD;
      Therefore, the investigators would like to determine the incidence of residual significant TR&#xD;
      by intraoperative TEE in the patients underwent left-side cardiac surgery and the related&#xD;
      clinical outcome, including rate of re-admission from cardiac cause and 1- year mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2020</start_date>
  <completion_date type="Actual">April 30, 2022</completion_date>
  <primary_completion_date type="Actual">April 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with residual significant tricuspid regurgitation after left-sided cardiac surgery</measure>
    <time_frame>during surgery</time_frame>
    <description>Residual significant tricuspid regurgitation: more than moderate tricuspid regurgitation after corrective surgery&#xD;
Left-sided cardiac surgery: mitral or aortic valve surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with different severity of tricuspid regurgitation</measure>
    <time_frame>during surgery</time_frame>
    <description>Compare between preoperative trans- thoracic echocardiography and intraoperative transesophageal echocardiography result (before cardiopulmonary bypass initiation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>7 days after surgery</time_frame>
    <description>Length of hospital and ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients require re-operation</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>Re-operation for tricuspid regurgitation correction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients require re-admission</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>Re-admission due to cardiac cause: right-sided cardiac failure, pulmonary oedema</description>
  </secondary_outcome>
  <enrollment type="Actual">275</enrollment>
  <condition>Residual Tricuspid Regurgitation</condition>
  <condition>Left-sided Cardiac Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The patients scheduled for surgery according to the criteria in Siriraj hospital, Mahidol&#xD;
        university will be recruited&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mitral valve or aortic valve diseases requiring surgical intervention&#xD;
&#xD;
          -  No pathologic changes in TV leaflets&#xD;
&#xD;
          -  No previous tricuspid valve surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with incomplete data&#xD;
&#xD;
          -  Patient with history of previous cardiac surgery&#xD;
&#xD;
          -  Patient with congenital anomalies of mitral or tricuspid valve&#xD;
&#xD;
          -  Patient with both tricuspid stenosis and 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>Aphichat Suphathamwit, M.D&gt;</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine Siriraj Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>Anyanwu AC, Adams DH. Functional tricuspid regurgitation in mitral valve disease: epidemiology and prognostic implications. Semin Thorac Cardiovasc Surg. 2010 Spring;22(1):69-75. doi: 10.1053/j.semtcvs.2010.05.006.</citation>
    <PMID>20813320</PMID>
  </reference>
  <reference>
    <citation>Hamandi M, George TJ, Smith RL, Mack MJ. Current outcomes of tricuspid valve surgery. Prog Cardiovasc Dis. 2019 Nov-Dec;62(6):463-466. doi: 10.1016/j.pcad.2019.11.014. Epub 2019 Dec 2.</citation>
    <PMID>31805294</PMID>
  </reference>
  <reference>
    <citation>Calafiore AM, Foschi M, Kheirallah H, Alsaied MM, Alfonso JJ, Tancredi F, Gaudino M, Di Mauro M. Early failure of tricuspid annuloplasty. Should we repair the tricuspid valve at an earlier stage? The role of right ventricle and tricuspid apparatus. J Card Surg. 2019 Jun;34(6):404-411. doi: 10.1111/jocs.14042. Epub 2019 Apr 8.</citation>
    <PMID>30958905</PMID>
  </reference>
  <verification_date>May 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>May 12, 2022</last_update_submitted>
  <last_update_submitted_qc>May 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 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>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/NCT04414358
org study id: 2020-3
nct id: NCT04414358
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Functional tricuspid valve regurgitation is commonly co-existed with left-sided cardiac
      lesion, especially mitral valve stenosis. Both lesion were recommended to surgically fixed at
      the same setting. Residual tricuspid regurgitation may effects patients' outcome. The
      investigators would like to determine the incidence of significant residual tricuspid
      regurgitation after left-sided cardiac surgery and related clinical outcome.
Functional tricuspid regurgitation (TR) was defined as TR occurring secondary to left heart,
      especially mitral valve stenosis or pulmonary disease. Previous study reported that about 30%
      - 50% of patients with significant mitral stenosis developed moderate to severe TR. In the
      past, corrective TR repair was not always indicated because the concept about TR severity
      will improve after mitral valve lesion was treated.

      Later on, several studies demonstrated that the patients with untreated significant (<
      moderate) TR had worse clinical outcome including mortality. While simultaneous functional TR
      repair with left-sided valve surgery did not cause adverse events, but improve clinical
      outcome and quality of life. The current European Society of Cardiology (ESC)/European
      Association for Cardio-Thoracic Surgery (EACTS) and American Heart Association(AHA)/American
      College of Cardiology (ACC) guidelines recommend concomitant tricuspid valve (TV) surgery in
      patients with severe TR undergoing left-sided valve surgery (class I recommendation). In
      patients with mild to moderate TR, there is a class IIa indication for concomitant TV surgery
      in the setting of tricuspid annular dilatation.

      However, after TV repair, commonly with annuloplasty ring or De Vega annuloplasty, residual
      TR may still persist and the residual moderate or severe TR have negative impact to right
      ventricle (RV). It can cause RV dilatation and RV failure(7, 12). Calafiore et al reported
      12.4% of significant TR after surgery and the associated factors for the repair failure. If
      this group of patients developed symptom of RV failure or progressive RV dilatation or
      dysfunction is detected, they possessed very high-risk for re-operation.

      Preoperative transthoracic echocardiography (TTE) is an important tool to classified severity
      of TR, measured TV annulus, indicate the surgical correction requirement and demonstrate the
      result of the TR repair. Due to limitation of TTE operator and machine, time-interval between
      the latest preoperative TTE result and surgery are varied, so the TR severity may already
      changed. The postoperative TTE result sometimes comes out late after surgery. Therefore,
      transesophageal echocardiography (TEE), operated by trained cardiac anesthesiologist, may
      play role to confirm the severity and provide the instant result of the TV repair to help
      guide the cardiac surgeon to make a decision whether to re-operate in the same setting to
      improve the surgical outcome.

      Therefore, the investigators would like to determine the incidence of residual significant TR
      by intraoperative TEE in the patients underwent left-side cardiac surgery and the related
      clinical outcome, including rate of re-admission from cardiac cause and 1- year mortality.
observational model: Cohort
time perspective: Retrospective
measure: Number of patients with residual significant tricuspid regurgitation after left-sided cardiac surgery
time frame: during surgery
description: Residual significant tricuspid regurgitation: more than moderate tricuspid regurgitation after corrective surgery
Left-sided cardiac surgery: mitral or aortic valve surgery
measure: Number of patients with different severity of tricuspid regurgitation
time frame: during surgery
description: Compare between preoperative trans- thoracic echocardiography and intraoperative transesophageal echocardiography result (before cardiopulmonary bypass initiation)
measure: Length of stay
time frame: 7 days after surgery
description: Length of hospital and ICU stay
measure: Number of patients require re-operation
time frame: 1 year after surgery
description: Re-operation for tricuspid regurgitation correction
measure: Number of patients require re-admission
time frame: 1 year after surgery
description: Re-admission due to cardiac cause: right-sided cardiac failure, pulmonary oedema
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aphichat Suphathamwit, M.D>
role: Principal Investigator
affiliation: Mahidol University
facility: 
country: Thailand
citation: Anyanwu AC, Adams DH. Functional tricuspid regurgitation in mitral valve disease: epidemiology and prognostic implications. Semin Thorac Cardiovasc Surg. 2010 Spring;22(1):69-75. doi: 10.1053/j.semtcvs.2010.05.006.
PMID: 20813320
citation: Hamandi M, George TJ, Smith RL, Mack MJ. Current outcomes of tricuspid valve surgery. Prog Cardiovasc Dis. 2019 Nov-Dec;62(6):463-466. doi: 10.1016/j.pcad.2019.11.014. Epub 2019 Dec 2.
PMID: 31805294
citation: Calafiore AM, Foschi M, Kheirallah H, Alsaied MM, Alfonso JJ, Tancredi F, Gaudino M, Di Mauro M. Early failure of tricuspid annuloplasty. Should we repair the tricuspid valve at an earlier stage? The role of right ventricle and tricuspid apparatus. J Card Surg. 2019 Jun;34(6):404-411. doi: 10.1111/jocs.14042. Epub 2019 Apr 8.
PMID: 30958905
responsible party type: Sponsor
mesh term: Tricuspid Valve Insufficiency
sharing ipd: No