<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/NCT03283722</url>
  </required_header>
  <id_info>
    <org_study_id>MDT16016SUR002</org_study_id>
    <nct_id>NCT03283722</nct_id>
  </id_info>
  <brief_title>PRESERVE-MITRAL Post-Market Registry</brief_title>
  <official_title>Prospective REgistry to Study Clinical OutcomEs of Repair of Mitral ValvEs in South Asia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Cardiac Surgery</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiac Surgery</source>
  <oversight_info>
    <has_dmc>No</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 objective of this registry is to gather data on the clinical outcomes of Medtronic mitral&#xD;
      repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended&#xD;
      use up to 12 months from the day of procedure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is limited local evidence on mitral repair products in South Asia and a prospective&#xD;
      post market registry will provide real world data on clinical outcomes.&#xD;
&#xD;
      Patients suffering from mitral valve disease and indicated for a mitral valve repair&#xD;
      procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in&#xD;
      accordance with the product label indications (instructions for use), contraindications, and&#xD;
      warnings will be considered for study participation.&#xD;
&#xD;
      PRESERVE-Mitral Registry is a prospective non-randomized, non-interventional, post-market&#xD;
      registry&#xD;
&#xD;
      The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral&#xD;
      repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended&#xD;
      use up to 12 months from the day of procedure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">February 10, 2021</completion_date>
  <primary_completion_date type="Actual">February 10, 2021</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>Improvement in Mitral Regurgitation (MR) grade</measure>
    <time_frame>12 months</time_frame>
    <description>Improvement in Mitral Regurgitation grade</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All cause mortality</measure>
    <time_frame>12 months</time_frame>
    <description>All deaths occurring from any cause post procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient baseline and pathophysiology</measure>
    <time_frame>12 months</time_frame>
    <description>Characterization of patient baseline demographics age, sex, height (cm), weight (kg) and pathophysiology of mitral valve disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in MR grade at discharge and first follow up</measure>
    <time_frame>3-6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in New York Heart Association (NYHA) functional class at discharge, first follow up (3-6 months) and second follow up (12 months) compared to baseline</measure>
    <time_frame>At 7 days post procedure, 3-6 months &amp; 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for Heart Failure at 6 months and at 12 months post procedure</measure>
    <time_frame>6 months and 12 months post procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mitral valve re-intervention at discharge, 6 months and at 12 months post procedure</measure>
    <time_frame>At 7 days post procedure, 6 months and 12 months post procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke at 6 months and at 12 months post procedure</measure>
    <time_frame>6 months and 12 months post procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset of Atrial Fibrillation at discharge, first follow up (3-6 months) and at second follow up (12 months)</measure>
    <time_frame>At 7 days post procedure, 3-6 months, 12 months</time_frame>
    <description>As evaluated through follow up ECG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure details</measure>
    <time_frame>During the procedure</time_frame>
    <description>Number of attempts required for procedural success, and bypass time as a measure of procedural complexity, as measured by standard operating room procedures at the site.</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Mitral Valve Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Profile 3D™ and CG Future® annuloplasty system</intervention_name>
    <description>Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from mitral valve disease and indicated for a mitral valve repair&#xD;
        procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care,&#xD;
        in accordance with the product label indications (instructions for use), contraindications,&#xD;
        and warnings&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with valvular insufficiency and/or stenosis and indicated for the&#xD;
             reconstruction and/or remodeling of pathological mitral valves with Profile 3D™ and CG&#xD;
             Future® annuloplasty systems&#xD;
&#xD;
          2. Indications and contraindications provided in the product Instructions for Use&#xD;
&#xD;
          3. Subject is 18 years of age or older&#xD;
&#xD;
          4. The patient or his/her Legally Authorized Representative (LAR) has been informed about&#xD;
             the nature of the registry and the patient informed consent for study participation&#xD;
             has been obtained prior to performing any study-related procedures from the subject or&#xD;
             Legally Authorized Representative, as per applicable local requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications as per instructions-for-use (IFU):&#xD;
&#xD;
               1. Heavily calcified valves&#xD;
&#xD;
               2. Valvular retraction with severely reduced mobility&#xD;
&#xD;
               3. Active bacterial endocarditis&#xD;
&#xD;
          2. Aortic valve replacement as concomitant procedure&#xD;
&#xD;
          3. Already participating in another clinical study, possibly leading to bias and&#xD;
             jeopardizing the scientific appropriate assessment of the study endpoints&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vinay Rajan, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Medtronic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Heart Foundation Hospital &amp; Research Institute</name>
      <address>
        <city>Dhaka</city>
        <zip>1216</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U. N. Mehta Institute of Cardiology and Research Centre</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380016</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SAL Hospital &amp; Medical Institute</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EPIC Hospital</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sri Jayadeva Institute of Cardiovascular Sciences &amp; Research</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560069</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narayana Institute of Cardiac Sciences</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560099</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amrita Institute of Medical Sciences and Research Center</name>
      <address>
        <city>Kochi</city>
        <state>Kerala</state>
        <zip>682041</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P.D. Hinduja National Hospital and Medical Research Centre</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400016</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Madras Medical Mission</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600037</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>G. Kuppuswamy Memorial Hospital</name>
      <address>
        <city>Coimbatore</city>
        <state>Tamil Nadu</state>
        <zip>641037</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CARE Hospitals</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manmohan Cardiothoracic Vascular and Transplant Center</name>
      <address>
        <city>Kathmandu</city>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
    <country>India</country>
    <country>Nepal</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03283722
org study id: MDT16016SUR002
nct id: NCT03283722
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral
      repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended
      use up to 12 months from the day of procedure
There is limited local evidence on mitral repair products in South Asia and a prospective
      post market registry will provide real world data on clinical outcomes.

      Patients suffering from mitral valve disease and indicated for a mitral valve repair
      procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in
      accordance with the product label indications (instructions for use), contraindications, and
      warnings will be considered for study participation.

      PRESERVE-Mitral Registry is a prospective non-randomized, non-interventional, post-market
      registry

      The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral
      repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended
      use up to 12 months from the day of procedure
observational model: Cohort
time perspective: Prospective
measure: Improvement in Mitral Regurgitation (MR) grade
time frame: 12 months
description: Improvement in Mitral Regurgitation grade
measure: All cause mortality
time frame: 12 months
description: All deaths occurring from any cause post procedure
measure: Patient baseline and pathophysiology
time frame: 12 months
description: Characterization of patient baseline demographics age, sex, height (cm), weight (kg) and pathophysiology of mitral valve disease
measure: Improvement in MR grade at discharge and first follow up
time frame: 3-6 months
measure: Improvement in New York Heart Association (NYHA) functional class at discharge, first follow up (3-6 months) and second follow up (12 months) compared to baseline
time frame: At 7 days post procedure, 3-6 months & 12 months
measure: Hospitalization for Heart Failure at 6 months and at 12 months post procedure
time frame: 6 months and 12 months post procedure
measure: Mitral valve re-intervention at discharge, 6 months and at 12 months post procedure
time frame: At 7 days post procedure, 6 months and 12 months post procedure
measure: Stroke at 6 months and at 12 months post procedure
time frame: 6 months and 12 months post procedure
measure: New onset of Atrial Fibrillation at discharge, first follow up (3-6 months) and at second follow up (12 months)
time frame: At 7 days post procedure, 3-6 months, 12 months
description: As evaluated through follow up ECG
measure: Procedure details
time frame: During the procedure
description: Number of attempts required for procedural success, and bypass time as a measure of procedural complexity, as measured by standard operating room procedures at the site.
intervention type: Device
intervention name: Profile 3D™ and CG Future® annuloplasty system
description: Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Vinay Rajan, Ph.D
role: Study Chair
affiliation: Medtronic
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Bangladesh
country: India
country: Nepal
responsible party type: Sponsor
sharing ipd: Undecided