<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/NCT02245763</url>
  </required_header>
  <id_info>
    <org_study_id>3000-2</org_study_id>
    <nct_id>NCT02245763</nct_id>
  </id_info>
  <brief_title>STS/ACC TVT Registry Mitral Module</brief_title>
  <acronym>TMVR</acronym>
  <official_title>The Society of Thoracic Surgeons/ American College of Cardiology Transcatheter Valve Therapies Registry Mitral Module</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American College of Cardiology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Society of Thoracic Surgeons</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>American College of Cardiology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world&#xD;
      outcomes related to the transcatheter mitral valve repair (TMVR) procedure. Created by The&#xD;
      Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT&#xD;
      Registry is designed to monitor the safety and efficacy of this new procedure for the&#xD;
      treatment of mitral valve disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The TVT Registry was designed to support a national surveillance system to assess the&#xD;
      characteristics, treatments, and outcomes of patients receiving transcutaneous valve&#xD;
      therapies. Patient-level data are submitted by participating hospitals to The Society of&#xD;
      Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT&#xD;
      Registry. The purposes of the TVT Registry include: (i) collecting pertinent and standardized&#xD;
      data elements from participating hospitals, health care providers and others that measure and&#xD;
      assess the quality of care for patients receiving TVT; (ii) providing confidential periodic&#xD;
      reports to participating hospitals, health care providers and others, to evaluate and improve&#xD;
      the quality of care in these areas; and (iii) permitting and fostering appropriate research&#xD;
      based upon the data collected by means of the TVT Registry.&#xD;
&#xD;
      The secondary aim of the TVT Registry is to serve as a scalable data infrastructure for post&#xD;
      market studies.&#xD;
&#xD;
      Background and Significance&#xD;
&#xD;
      Transcatheter valve therapies are now emerging into clinical practice from the research phase&#xD;
      in the United States. An Expert Consensus Document on Transcatheter Valve Therapy has&#xD;
      outlined the initial technology, targeted patient population, and the multidisciplinary heart&#xD;
      team and specialized facilities needed. The document also proposes the establishment of a&#xD;
      national registry of patients with valvular heart disease that can collect and analyze data&#xD;
      as these new valve treatment options become available. Surveillance of device performance,&#xD;
      monitoring of long-term outcomes, and performance of comparative effectiveness research are&#xD;
      some of the proposed uses of the registry.&#xD;
&#xD;
      Transcatheter valve therapies have emerged because of unmet patient needs. Furthermore, TVT&#xD;
      has developed at a time when degenerative heart valve diseases of both the mitral and aortic&#xD;
      valves are increasing in frequency as the population ages.&#xD;
&#xD;
      For these patients there are unique issues such as the prioritization of the health related&#xD;
      quality of life versus the quantity of life, the desire to preserve independence and avoid&#xD;
      becoming a burden to families, and the need to clearly understand what about their current&#xD;
      condition is reversible versus irreversible and linked to other conditions and aging. These&#xD;
      issues become further highlighted when considering the considerable costs and other treatment&#xD;
      burdens of the TVT technologies versus the disabling symptoms and recurrent hospitalizations&#xD;
      caused by untreated severe valvular heart disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 2030</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients with Adverse Events</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Mitral Valve Regurgitation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Leaflet Clip</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Transcatheter Mitral Valve Repair must be furnished in a hospital with the appropriate&#xD;
        infrastructre that includes, but is not limited to on site heart valve surgery program&#xD;
        cardiac catheterization lab or hybrid operating room with a fixed radiographic imaging&#xD;
        system with flat panel fluoroscopy, offering quality imaging non-invasive imaging such as&#xD;
        echocardiography, vascular ultrasound, computed tomography and magnetic resonance.&#xD;
        Sufficient space, in a sterile environment, to accommodate necessary equipment for cases&#xD;
        with and without complications. Post-procedure intensive care facility with personnel&#xD;
        experienced in managing patients who have undergone open-heart valve procedures.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who cannot tolerate procedural anticoagulation or post procedural&#xD;
             anti-platelet regimen&#xD;
&#xD;
          -  Active endocarditis of the mitral valve&#xD;
&#xD;
          -  Rheumatic mitral valve disease&#xD;
&#xD;
          -  Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Joan K Michaels, RN</last_name>
    <phone>202-375-6309</phone>
    <email>jmichael@acc.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>American College of Cardiology</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.ncdr.com/TVT/Home/Default.aspx</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>February 1, 2022</last_update_submitted>
  <last_update_submitted_qc>February 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 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>Mitral Valve Insufficiency</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/NCT02245763
org study id: 3000-2
nct id: NCT02245763
lead sponsor: 
collaborator: 
has dmc: Yes
The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world
      outcomes related to the transcatheter mitral valve repair (TMVR) procedure. Created by The
      Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT
      Registry is designed to monitor the safety and efficacy of this new procedure for the
      treatment of mitral valve disease.
The TVT Registry was designed to support a national surveillance system to assess the
      characteristics, treatments, and outcomes of patients receiving transcutaneous valve
      therapies. Patient-level data are submitted by participating hospitals to The Society of
      Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT
      Registry. The purposes of the TVT Registry include: (i) collecting pertinent and standardized
      data elements from participating hospitals, health care providers and others that measure and
      assess the quality of care for patients receiving TVT; (ii) providing confidential periodic
      reports to participating hospitals, health care providers and others, to evaluate and improve
      the quality of care in these areas; and (iii) permitting and fostering appropriate research
      based upon the data collected by means of the TVT Registry.

      The secondary aim of the TVT Registry is to serve as a scalable data infrastructure for post
      market studies.

      Background and Significance

      Transcatheter valve therapies are now emerging into clinical practice from the research phase
      in the United States. An Expert Consensus Document on Transcatheter Valve Therapy has
      outlined the initial technology, targeted patient population, and the multidisciplinary heart
      team and specialized facilities needed. The document also proposes the establishment of a
      national registry of patients with valvular heart disease that can collect and analyze data
      as these new valve treatment options become available. Surveillance of device performance,
      monitoring of long-term outcomes, and performance of comparative effectiveness research are
      some of the proposed uses of the registry.

      Transcatheter valve therapies have emerged because of unmet patient needs. Furthermore, TVT
      has developed at a time when degenerative heart valve diseases of both the mitral and aortic
      valves are increasing in frequency as the population ages.

      For these patients there are unique issues such as the prioritization of the health related
      quality of life versus the quantity of life, the desire to preserve independence and avoid
      becoming a burden to families, and the need to clearly understand what about their current
      condition is reversible versus irreversible and linked to other conditions and aging. These
      issues become further highlighted when considering the considerable costs and other treatment
      burdens of the TVT technologies versus the disabling symptoms and recurrent hospitalizations
      caused by untreated severe valvular heart disease.
observational model: Cohort
time perspective: Prospective
measure: Number of Patients with Adverse Events
time frame: 30 days
intervention type: Device
intervention name: Leaflet Clip
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joan K Michaels, RN
phone: 202-375-6309
email: jmichael@acc.org
facility: 
status: Recruiting
country: United States
url: http://www.ncdr.com/TVT/Home/Default.aspx
description: Related Info
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency