<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/NCT04494347</url>
  </required_header>
  <id_info>
    <org_study_id>19-010047</org_study_id>
    <nct_id>NCT04494347</nct_id>
  </id_info>
  <brief_title>Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)</brief_title>
  <acronym>WATCH-TMVR</acronym>
  <official_title>Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      WATCH-TMVR (Watchman for Patients with Atrial Fibrillation Undergoing Transcatheter Mitral&#xD;
      Valve) Clinical Trial have the main objective to assess the feasibility of combining&#xD;
      clinically indicated MitraClip TMVR and Watchman LAAO in one setting.Mayo Clinic will be the&#xD;
      data coordinating center for this trial, which will include up to 3 sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Left atrial appendage closure using the Watchman device procedure is approved by the FDA for&#xD;
      patients with nonvalvular atrial fibrillation who have an indication for oral anticoagulation&#xD;
      to reduce stroke risk but who also have a rational to seek an alternative to long-term&#xD;
      anticoagulation (e.g., recurrent bleeding, fall risk). Transcatheter mitral valve repair with&#xD;
      the MitraClip device is approved by the FDA for patients with severe degenerative mitral&#xD;
      regurgitation who are deemed to be at high-risk for valve surgery and patients with severe&#xD;
      secondary MR despite optimal medical therapy. It is also anticipated that the device will&#xD;
      soon be approved for patients with severe symptomatic functional mitral regurgitation based&#xD;
      on the results of the COAPT trials. Atrial fibrillation is common in patients referred for&#xD;
      TMVr. A recent study from the Mayo Clinic documented that up to 50% of patients undergoing&#xD;
      TMVr might qualify for LAA based on their risk assessment. Both procedures are performed via&#xD;
      a large bore femoral venous access, and utilize transseptal puncture, general anesthesia, and&#xD;
      transesophageal echo guidance. Hence, combining the two procedures in one session might&#xD;
      provide incremental benefit to those patients by avoiding the risk of repeated large-bore&#xD;
      access, transseptal puncture, and general anesthesia. A limited number of case reports&#xD;
      illustrated the safety and feasibility of a combined TMVr with LAAO when clinically&#xD;
      indicated. Experience with combined TMVr/LAAO in the United States is limited, mostly due to&#xD;
      the lack of supportive data and concerns about the incremental cost of the Watchman device&#xD;
      that might not be covered by the Center for Medicare Services (CMS) per current guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 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>
    <intervention_model_description>This is a prospective multicenter registry of 25 patients who are planned to undergo TMVr with MitraClip and also have an indication for LAAO with the commercially available WATCHMAN device. All patients will undergo TMVr first under general anesthesia and transesophageal echo (TEE) guidance. At the conclusion of the TMVr procedure, the patient will undergo LAAO with the Watchman device using the same transseptal access the was obtained to perform the TMVr. Patients will receive oral anticoagulation with warfarin (or a direct anticoagulant) and subsequent antiplatelet therapy as per standard of care and outlined in protocol for 6 weeks. After 6 weeks, patients will have TEE done as per standard of care in addition to office visit and complete clinical and neurological evaluation. Continuation or discontinuation of oral anticoagulation will depend on the 45-day TEE findings. The anticipated duration of the Clinical Investigation will be 12 months.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality rate</measure>
    <time_frame>45 days post procedure</time_frame>
    <description>Total number of Subject's Death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All-cause mortality rate</measure>
    <time_frame>1 Year post procedure</time_frame>
    <description>Total number of Subject's Death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serious Adverse Events (SAEs)</measure>
    <time_frame>45 days post procedure</time_frame>
    <description>Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serious Adverse Events (SAEs)</measure>
    <time_frame>1 Year post procedure</time_frame>
    <description>Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SAEs related to the Study devices</measure>
    <time_frame>1 Year</time_frame>
    <description>Total number of the Subject's to experience SAEs as related to Watchman and the LAAO devices.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Nonvalvular Atrial Fibrillation</condition>
  <condition>Severe Degenerative Mitral Regurgitation</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is not a randomized study. Patients who are clinically indicated for both procedures will be offered the option to enroll in this registry for a combined procedure. Otherwise, they will undergo TMVr and LAAO in two separate session as clinically indicated (standard of care).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MitraClip TMVR and Watchman LAAO</intervention_name>
    <description>The MitraClip device is a percutaneous edge-to-edge repair device that is intended to approximate the anterior and posterior mitral valve leaflets in patients with severe symptomatic mitral regurgitation with suitable anatomy. Device versions/types: MitraClip NTr, MitraClip XTr. The WATCHMAN device is a self-expanding left atrial appendage occlusion (LAAO) device with a porous covering on the proximal face. Device sizes: 21 mm, 24 mm, 27 mm, 30 mm, 33 mm.</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and Women ≥ 18 years of age;&#xD;
&#xD;
          2. The patient has severe symptomatic mitral regurgitation meet criteria for the&#xD;
             commercially available MitraClip;&#xD;
&#xD;
          3. The patient also has documented paroxysmal, persistent, or permanent atrial&#xD;
             fibrillation AND The patient meets the WATCHMAN labeling guidelines;&#xD;
&#xD;
          4. The patient is eligible for short-term oral anticoagulation therapy with Warfarin or a&#xD;
             direct oral anticoagulant;&#xD;
&#xD;
          5. The patient or legal representative is able to understand and willing to provide&#xD;
             written informed consent to participate in the trial;&#xD;
&#xD;
          6. The patient is able and willing to return for required follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mitral valve anatomy not deemed suitable for TMVr;&#xD;
&#xD;
          2. Moderate to severe mitral stenosis (mean gradient &gt;10 mmHg or MVA &lt;1.5 cm2);&#xD;
&#xD;
          3. Contraindication for short-term anticoagulation;&#xD;
&#xD;
          4. The patient has intra-cardiac thrombus as visualized by TEE within 1 week prior to&#xD;
             Watchman procedure;&#xD;
&#xD;
          5. Prior occlusion of LAA;&#xD;
&#xD;
          6. Implanted mechanical mitral valve;&#xD;
&#xD;
          7. The patient requires long-term warfarin therapy due to:&#xD;
&#xD;
               1. Secondary to conditions such as prior arterial embolism or other indications such&#xD;
                  as pulmonary embolism or deep vein thrombosis within the previous 6 months.&#xD;
&#xD;
               2. The patient is in a hypercoagulable state.&#xD;
&#xD;
          8. Exclude the patient if per medical record documentation the patient meets any of the&#xD;
             following criteria: • Thrombosis occurring at under 40 years age • Idiopathic or&#xD;
             recurrent VTE (venous thromboembolism • Thrombosis at an unusual site (cerebral veins,&#xD;
             hepatic veins, renal veins, IVC, mesenteric veins) • Family history of VTE or of&#xD;
             inherited prothrombotic disorder, recurrence/extension of thrombosis while adequately&#xD;
             anti-coagulated;&#xD;
&#xD;
          9. The patient is actively enrolled in another trial of a cardiovascular device or an&#xD;
             investigational drug (post-market study and registries are acceptable);&#xD;
&#xD;
         10. The patient is pregnant, or pregnancy is planned during the course of the&#xD;
             investigation if patient is of child bearing potential;&#xD;
&#xD;
         11. Any clinically significant medical condition or presence of any laboratory abnormality&#xD;
             performed prior to randomization that is considered by the investigator to be&#xD;
             clinically important and could interfere with the conduct of the study or not meeting&#xD;
             procedure guidelines for WATCHMAN or TMVr with MitraClip;&#xD;
&#xD;
         12. The patient has a life expectancy of less than one year.&#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>Mohamad Adnan (Mohamad) Alkhouli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamad Adnan (Mohamad) Alkhouli, MD</last_name>
    <phone>507-255-2502</phone>
    <email>alkhouli.mohamad@mayo.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Love</last_name>
      <phone>507-422-2094</phone>
      <email>love.rachel@mayo.edu</email>
    </contact>
    <contact_backup>
      <last_name>Amanda Biddle, RN</last_name>
      <phone>507-538-5428</phone>
      <email>biddle.amanda@mayo.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hannah Feagan</last_name>
      <phone>613-696-7000</phone>
      <phone_ext>12678</phone_ext>
      <email>hfeagan@ottawaheart.ca</email>
    </contact>
    <investigator>
      <last_name>Benjamin Hibbert, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Mohamad Adnan Alkhouli</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Mitral 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/NCT04494347
org study id: 19-010047
nct id: NCT04494347
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
WATCH-TMVR (Watchman for Patients with Atrial Fibrillation Undergoing Transcatheter Mitral
      Valve) Clinical Trial have the main objective to assess the feasibility of combining
      clinically indicated MitraClip TMVR and Watchman LAAO in one setting.Mayo Clinic will be the
      data coordinating center for this trial, which will include up to 3 sites.
Left atrial appendage closure using the Watchman device procedure is approved by the FDA for
      patients with nonvalvular atrial fibrillation who have an indication for oral anticoagulation
      to reduce stroke risk but who also have a rational to seek an alternative to long-term
      anticoagulation (e.g., recurrent bleeding, fall risk). Transcatheter mitral valve repair with
      the MitraClip device is approved by the FDA for patients with severe degenerative mitral
      regurgitation who are deemed to be at high-risk for valve surgery and patients with severe
      secondary MR despite optimal medical therapy. It is also anticipated that the device will
      soon be approved for patients with severe symptomatic functional mitral regurgitation based
      on the results of the COAPT trials. Atrial fibrillation is common in patients referred for
      TMVr. A recent study from the Mayo Clinic documented that up to 50% of patients undergoing
      TMVr might qualify for LAA based on their risk assessment. Both procedures are performed via
      a large bore femoral venous access, and utilize transseptal puncture, general anesthesia, and
      transesophageal echo guidance. Hence, combining the two procedures in one session might
      provide incremental benefit to those patients by avoiding the risk of repeated large-bore
      access, transseptal puncture, and general anesthesia. A limited number of case reports
      illustrated the safety and feasibility of a combined TMVr with LAAO when clinically
      indicated. Experience with combined TMVr/LAAO in the United States is limited, mostly due to
      the lack of supportive data and concerns about the incremental cost of the Watchman device
      that might not be covered by the Center for Medicare Services (CMS) per current guidelines.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a prospective multicenter registry of 25 patients who are planned to undergo TMVr with MitraClip and also have an indication for LAAO with the commercially available WATCHMAN device. All patients will undergo TMVr first under general anesthesia and transesophageal echo (TEE) guidance. At the conclusion of the TMVr procedure, the patient will undergo LAAO with the Watchman device using the same transseptal access the was obtained to perform the TMVr. Patients will receive oral anticoagulation with warfarin (or a direct anticoagulant) and subsequent antiplatelet therapy as per standard of care and outlined in protocol for 6 weeks. After 6 weeks, patients will have TEE done as per standard of care in addition to office visit and complete clinical and neurological evaluation. Continuation or discontinuation of oral anticoagulation will depend on the 45-day TEE findings. The anticipated duration of the Clinical Investigation will be 12 months.
primary purpose: Treatment
masking: None (Open Label)
masking description: Open Label
measure: All-cause mortality rate
time frame: 45 days post procedure
description: Total number of Subject's Death
measure: All-cause mortality rate
time frame: 1 Year post procedure
description: Total number of Subject's Death
measure: Serious Adverse Events (SAEs)
time frame: 45 days post procedure
description: Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.
measure: Serious Adverse Events (SAEs)
time frame: 1 Year post procedure
description: Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.
measure: SAEs related to the Study devices
time frame: 1 Year
description: Total number of the Subject's to experience SAEs as related to Watchman and the LAAO devices.
arm group label: Treatment Group
arm group type: Experimental
description: This is not a randomized study. Patients who are clinically indicated for both procedures will be offered the option to enroll in this registry for a combined procedure. Otherwise, they will undergo TMVr and LAAO in two separate session as clinically indicated (standard of care).
intervention type: Procedure
intervention name: MitraClip TMVR and Watchman LAAO
description: The MitraClip device is a percutaneous edge-to-edge repair device that is intended to approximate the anterior and posterior mitral valve leaflets in patients with severe symptomatic mitral regurgitation with suitable anatomy. Device versions/types: MitraClip NTr, MitraClip XTr. The WATCHMAN device is a self-expanding left atrial appendage occlusion (LAAO) device with a porous covering on the proximal face. Device sizes: 21 mm, 24 mm, 27 mm, 30 mm, 33 mm.
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohamad Adnan (Mohamad) Alkhouli, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Mohamad Adnan (Mohamad) Alkhouli, MD
phone: 507-255-2502
email: alkhouli.mohamad@mayo.edu
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Mohamad Adnan Alkhouli
investigator title: Principal Investigator
mesh term: Atrial Fibrillation
mesh term: Mitral Valve Insufficiency
sharing ipd: No