<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/NCT04454177</url>
  </required_header>
  <id_info>
    <org_study_id>2020-330</org_study_id>
    <nct_id>NCT04454177</nct_id>
  </id_info>
  <brief_title>SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement</brief_title>
  <acronym>SMART TAVR</acronym>
  <official_title>SMART TAVR: SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to observe conduction disturbance, daily activity level, heart&#xD;
      rates, oxygen saturation in patients who underwent Transcatheter Aortic Valve Replacement&#xD;
      (TAVR) and to evaluate the utility of the HUAWEI Watch (HUAWEI Technologies Co., Ltd.,&#xD;
      Shenzhen, China) for the potential early warning sign of changes in multiple biometric&#xD;
      parameters including heart rate, rhythm, oxygen saturation, activity, and sleep in patients&#xD;
      following TAVR. This will be evaluated in the context of a recently implemented early&#xD;
      discharge protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective observational cohort study including patients undergoing TAVR procedure&#xD;
      in Second Affiliated Hospital of Zhejiang University, School of Medicine. HUAWEI Watch will&#xD;
      be assigned to patients within 24 hours before TAVR. HUAWEI Watch GT series can continuously&#xD;
      monitor and record multiple biometric parameters heart rate, step counts, sleep cycles and&#xD;
      can detect and record the pulse oxygen saturation, as well as analyze QRS complexes and P&#xD;
      waves after triggering. The patients will be followed in outpatient clinic visits at 1, 6,&#xD;
      12, 24, and 36 months after TAVR and will commence monitoring with the HUAWEI Watch protocol&#xD;
      at least 1 day before the scheduled TAVR procedure to allow familiarity with the device.&#xD;
      Patients will be required to activate SMART watch readings (including pulse oxygen saturation&#xD;
      and ECG) at least once prior to TAVR and twice per day in the week following TAVR discharge&#xD;
      (morning and late afternoon/early evening), at least two days a week for the subsequent month&#xD;
      after TAVR discharge and at least once weekly for the remainder of the study. Patients will&#xD;
      also be required to activate SMART watch readings at times of any cardiovascular symptoms&#xD;
      including dyspnea, chest pain, palpitations, dizziness or presyncope. The health data&#xD;
      recorded by HUAWEI Watch will be transmitted to HUAWEI phone application. The Heart Health&#xD;
      App (developed by Second Affiliated Hospital, School of Medicine, Zhejiang University) will&#xD;
      receive, process and store the data, and transfer it to remote database after approval by&#xD;
      patients. A designated heart team member would access the data via a cloud database, contact&#xD;
      the patient further investigation or management was deemed necessary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2031</completion_date>
  <primary_completion_date type="Anticipated">August 31, 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>Composite of Death and Rehospitalization</measure>
    <time_frame>30-day</time_frame>
    <description>Kaplan-Meier Estimate of Death or Rehospitalization from date of discharge, compared to a historical control. Rehospitalization is defined as any hospitalization related to the procedure, the valve or heart failure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Days Alive and Out of Hospital (DAOH)</measure>
    <time_frame>30-day</time_frame>
    <description>Kaplan-Meier Estimate of Days Alive and Out of Hospital (DAOH) from date of discharge, compared to a historical control.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite of Death and Rehospitalization</measure>
    <time_frame>1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Kaplan-Meier Estimate of Death or Rehospitalization from date of discharge, compared to a historical control. Rehospitalization is defined as any hospitalization related to the procedure, the valve or heart failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days Alive and Out of Hospital (DAOH)</measure>
    <time_frame>1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Kaplan-Meier Estimate of Days Alive and Out of Hospital (DAOH) from date of discharge, compared to a historical control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of pacemaker implantation</measure>
    <time_frame>30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Incidence of pacemaker implantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of pacemaker implantation</measure>
    <time_frame>30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Time of pacemaker implantation will record the time point of the pacemaker implantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New York Heart Association (NYHA) Functional Class</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I-IV, with the NYHA I as no limitation and NYHA IV unable to carry on any physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kansas City Cardiomyopathy Questionnaire (KCCQ)</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>The Kansas City Cardiomyopathy Questionnaire (KCCQ) are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Hemoglobin is mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pro-BNP</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Pro-BNP is pg/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Albumin is g/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Creatinine of umol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiography examinations</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Echocardiography examinations include valvular mean gradient, paravalvular leakage, valvular regurgitation, left ventricular ejection fraction, left ventricular diameter, left atrial size, and pulmonary arterial systolic pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Computed tomography examinations</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>computed tomography examinations include CT assessment parameters, like annular area, perimeter, diameter, SOV, and Coronary height.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of onset of conduction disturbance recorded by Watch</measure>
    <time_frame>30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Rates of onset of conduction disturbance recorded by Watch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of onset of conduction disturbance recorded by Watch</measure>
    <time_frame>30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Time of onset of conduction disturbance will record the time point of the onset of conduction disturbance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of onset of new atrial fibrillation or ventricular arrhythmia recorded by Watch</measure>
    <time_frame>30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Rates of onset of new atrial fibrillation or ventricular arrhythmia recorded by Watch.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of onset of new atrial fibrillation or ventricular arrhythmia recorded by Watch</measure>
    <time_frame>30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Time of new atrial fibrillation or ventricular arrhythmia will record the time point of the onset of new atrial fibrillation or ventricular arrhythmia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average daily step counts recorded by Watch</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Average daily step counts recorded by Watch is one assessment of daily activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Moderate to vigorous physical activity time recorded by Watch</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Moderate to vigorous physical activity time recorded by Watch is one assessment of daily activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SpO2 detected by Watch</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>SpO2 detected by Watch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate assessment recorded by Watch</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Heart rate assessment includes average heart rate, resting heart rate, and premature beats ratio recorded by Watch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of sleep reported by Watch</measure>
    <time_frame>baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Assessment of sleep reported by Watch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of cardiac event identified by the watch leading to change of therapy or intervention</measure>
    <time_frame>30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Rates of cardiac event identified by the watch leading to change of therapy or intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of cardiac event identified by the watch leading to change of therapy or intervention</measure>
    <time_frame>30-day, 6-month, 1-year, 2-year, and 3-year at follow-up</time_frame>
    <description>Time of cardiac event identified by the watch leading to change of therapy or intervention</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Aortic Stenosis</condition>
  <condition>Valvular Heart Disease</condition>
  <condition>Transcatheter Aortic Valve Replacement</condition>
  <arm_group>
    <arm_group_label>SMART watch</arm_group_label>
    <description>Medical records from patients aged 18 years or older undergoing Transcatheter Aortic Valve Replacement</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HUAWEI watch</intervention_name>
    <description>HUAWEI Watch will be assigned to patients within 24 hours before TAVR. HUAWEI Watch GT series can continuously monitor and record multiple biometric parameters heart rate, step counts, sleep cycles and can detect and record the pulse oxygen saturation, as well as analyze QRS complexes and P waves after triggering.</description>
    <arm_group_label>SMART watch</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 18 years or older who undergoing Transcatheter Aortic Valve Replacement were&#xD;
        the initial target population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years old;&#xD;
&#xD;
          -  Be willing and able to provide informed consent to participate in the study;&#xD;
&#xD;
          -  Not share HUAWEI Watch, HUAWEI phone with anyone else;&#xD;
&#xD;
          -  Patient has severe aortic stenosis with echocardiographically derived criteria: mean&#xD;
             gradient &gt; 40mmHg or maximum velocity greater than 4.0 m/s or an initial aortic valve&#xD;
             area of &lt; 1.0 cm2;&#xD;
&#xD;
          -  Patient who undergoing elective transfemoral transcatheter aortic valve replacement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe complications of TAVR, such as death, and conversion to SAVR;&#xD;
&#xD;
          -  Life expectancy is less than 12 months due to non-heart disease (such as cancer,&#xD;
             chronic liver disease, chronic kidney disease, or chronic end-stage lung disease,&#xD;
             etc.);&#xD;
&#xD;
          -  Severe dementia (cannot sign research informed consent, cannot take care of themselves&#xD;
             or complete the study visit);&#xD;
&#xD;
          -  The investigator believes that the patient is not suitable to participate in the study&#xD;
             or complete the follow-up prescribed by the protocol from other medical, social and&#xD;
             psychological aspects;&#xD;
&#xD;
          -  The patient is currently participating in another randomized study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jian-an Wang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiaqi Fan, MD</last_name>
    <phone>+86-15267029492</phone>
    <email>fanjiaqi@zju.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xianbao Liu, MD, PhD</last_name>
    <phone>+86-13857173887</phone>
    <email>liuxb2009@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Second Affiliated Hospital, School of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xianbao Liu, MD, PhD</last_name>
      <phone>+86-13857173887</phone>
      <email>liuxb2009@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Jiaqi Fan, MD</last_name>
      <phone>+86-15267029492</phone>
      <email>fanjiaqi@zju.edu.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Jian-an Wang, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>October 25, 2020</last_update_submitted>
  <last_update_submitted_qc>October 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</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>Heart Diseases</mesh_term>
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Heart Valve Diseases</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/NCT04454177
org study id: 2020-330
nct id: NCT04454177
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to observe conduction disturbance, daily activity level, heart
      rates, oxygen saturation in patients who underwent Transcatheter Aortic Valve Replacement
      (TAVR) and to evaluate the utility of the HUAWEI Watch (HUAWEI Technologies Co., Ltd.,
      Shenzhen, China) for the potential early warning sign of changes in multiple biometric
      parameters including heart rate, rhythm, oxygen saturation, activity, and sleep in patients
      following TAVR. This will be evaluated in the context of a recently implemented early
      discharge protocol.
This is a prospective observational cohort study including patients undergoing TAVR procedure
      in Second Affiliated Hospital of Zhejiang University, School of Medicine. HUAWEI Watch will
      be assigned to patients within 24 hours before TAVR. HUAWEI Watch GT series can continuously
      monitor and record multiple biometric parameters heart rate, step counts, sleep cycles and
      can detect and record the pulse oxygen saturation, as well as analyze QRS complexes and P
      waves after triggering. The patients will be followed in outpatient clinic visits at 1, 6,
      12, 24, and 36 months after TAVR and will commence monitoring with the HUAWEI Watch protocol
      at least 1 day before the scheduled TAVR procedure to allow familiarity with the device.
      Patients will be required to activate SMART watch readings (including pulse oxygen saturation
      and ECG) at least once prior to TAVR and twice per day in the week following TAVR discharge
      (morning and late afternoon/early evening), at least two days a week for the subsequent month
      after TAVR discharge and at least once weekly for the remainder of the study. Patients will
      also be required to activate SMART watch readings at times of any cardiovascular symptoms
      including dyspnea, chest pain, palpitations, dizziness or presyncope. The health data
      recorded by HUAWEI Watch will be transmitted to HUAWEI phone application. The Heart Health
      App (developed by Second Affiliated Hospital, School of Medicine, Zhejiang University) will
      receive, process and store the data, and transfer it to remote database after approval by
      patients. A designated heart team member would access the data via a cloud database, contact
      the patient further investigation or management was deemed necessary.
observational model: Cohort
time perspective: Prospective
measure: Composite of Death and Rehospitalization
time frame: 30-day
description: Kaplan-Meier Estimate of Death or Rehospitalization from date of discharge, compared to a historical control. Rehospitalization is defined as any hospitalization related to the procedure, the valve or heart failure.
measure: Days Alive and Out of Hospital (DAOH)
time frame: 30-day
description: Kaplan-Meier Estimate of Days Alive and Out of Hospital (DAOH) from date of discharge, compared to a historical control.
measure: Composite of Death and Rehospitalization
time frame: 1-year, 2-year, and 3-year at follow-up
description: Kaplan-Meier Estimate of Death or Rehospitalization from date of discharge, compared to a historical control. Rehospitalization is defined as any hospitalization related to the procedure, the valve or heart failure.
measure: Days Alive and Out of Hospital (DAOH)
time frame: 1-year, 2-year, and 3-year at follow-up
description: Kaplan-Meier Estimate of Days Alive and Out of Hospital (DAOH) from date of discharge, compared to a historical control.
measure: Incidence of pacemaker implantation
time frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Incidence of pacemaker implantation.
measure: Time of pacemaker implantation
time frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Time of pacemaker implantation will record the time point of the pacemaker implantation.
measure: New York Heart Association (NYHA) Functional Class
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I-IV, with the NYHA I as no limitation and NYHA IV unable to carry on any physical activity.
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: The Kansas City Cardiomyopathy Questionnaire (KCCQ) are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status.
measure: Hemoglobin
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Hemoglobin is mg/dL.
measure: Pro-BNP
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Pro-BNP is pg/mL.
measure: Albumin
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Albumin is g/L.
measure: Creatinine
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Creatinine of umol/L.
measure: Echocardiography examinations
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Echocardiography examinations include valvular mean gradient, paravalvular leakage, valvular regurgitation, left ventricular ejection fraction, left ventricular diameter, left atrial size, and pulmonary arterial systolic pressure.
measure: Computed tomography examinations
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: computed tomography examinations include CT assessment parameters, like annular area, perimeter, diameter, SOV, and Coronary height.
measure: Rates of onset of conduction disturbance recorded by Watch
time frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Rates of onset of conduction disturbance recorded by Watch
measure: Time of onset of conduction disturbance recorded by Watch
time frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Time of onset of conduction disturbance will record the time point of the onset of conduction disturbance.
measure: Rates of onset of new atrial fibrillation or ventricular arrhythmia recorded by Watch
time frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Rates of onset of new atrial fibrillation or ventricular arrhythmia recorded by Watch.
measure: Time of onset of new atrial fibrillation or ventricular arrhythmia recorded by Watch
time frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Time of new atrial fibrillation or ventricular arrhythmia will record the time point of the onset of new atrial fibrillation or ventricular arrhythmia.
measure: Average daily step counts recorded by Watch
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Average daily step counts recorded by Watch is one assessment of daily activity.
measure: Moderate to vigorous physical activity time recorded by Watch
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Moderate to vigorous physical activity time recorded by Watch is one assessment of daily activity.
measure: SpO2 detected by Watch
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: SpO2 detected by Watch
measure: Heart rate assessment recorded by Watch
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Heart rate assessment includes average heart rate, resting heart rate, and premature beats ratio recorded by Watch
measure: Assessment of sleep reported by Watch
time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Assessment of sleep reported by Watch
measure: Rates of cardiac event identified by the watch leading to change of therapy or intervention
time frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Rates of cardiac event identified by the watch leading to change of therapy or intervention
measure: Time of cardiac event identified by the watch leading to change of therapy or intervention
time frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
description: Time of cardiac event identified by the watch leading to change of therapy or intervention
arm group label: SMART watch
description: Medical records from patients aged 18 years or older undergoing Transcatheter Aortic Valve Replacement
intervention type: Device
intervention name: HUAWEI watch
description: HUAWEI Watch will be assigned to patients within 24 hours before TAVR. HUAWEI Watch GT series can continuously monitor and record multiple biometric parameters heart rate, step counts, sleep cycles and can detect and record the pulse oxygen saturation, as well as analyze QRS complexes and P waves after triggering.
arm group label: SMART watch
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Jian-an Wang, MD, PhD
role: Principal Investigator
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
last name: Jiaqi Fan, MD
phone: +86-15267029492
email: fanjiaqi@zju.edu.cn
last name: Xianbao Liu, MD, PhD
phone: +86-13857173887
email: liuxb2009@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Aortic Valve Stenosis
mesh term: Heart Valve Diseases
sharing ipd: No