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SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement (SMART TAVR)

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ClinicalTrials.gov Identifier: NCT04454177
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
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.

Condition or disease Intervention/treatment
Aortic Stenosis Valvular Heart Disease Transcatheter Aortic Valve Replacement Device: HUAWEI watch

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SMART TAVR: SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : July 1, 2031

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
SMART watch
Medical records from patients aged 18 years or older undergoing Transcatheter Aortic Valve Replacement
Device: HUAWEI watch
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.




Primary Outcome Measures :
  1. Composite of Death and Rehospitalization [ Time Frame: 30-day ]
    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.

  2. Days Alive and Out of Hospital (DAOH) [ Time Frame: 30-day ]
    Kaplan-Meier Estimate of Days Alive and Out of Hospital (DAOH) from date of discharge, compared to a historical control.


Secondary Outcome Measures :
  1. Composite of Death and Rehospitalization [ Time Frame: 1-year, 2-year, and 3-year at follow-up ]
    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.

  2. Days Alive and Out of Hospital (DAOH) [ Time Frame: 1-year, 2-year, and 3-year at follow-up ]
    Kaplan-Meier Estimate of Days Alive and Out of Hospital (DAOH) from date of discharge, compared to a historical control.

  3. Incidence of pacemaker implantation [ Time Frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    Incidence of pacemaker implantation.

  4. Time of pacemaker implantation [ Time Frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    Time of pacemaker implantation will record the time point of the pacemaker implantation.

  5. New York Heart Association (NYHA) Functional Class [ Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    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.

  6. Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    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.

  7. Hemoglobin [ Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Hemoglobin is mg/dL.

  8. Pro-BNP [ Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Pro-BNP is pg/mL.

  9. Albumin [ Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Albumin is g/L.

  10. Creatinine [ Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Creatinine of umol/L.

  11. Echocardiography examinations [ Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    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.

  12. Computed tomography examinations [ Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    computed tomography examinations include CT assessment parameters, like annular area, perimeter, diameter, SOV, and Coronary height.

  13. 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 ]
    Rates of onset of conduction disturbance recorded by Watch

  14. 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 ]
    Time of onset of conduction disturbance will record the time point of the onset of conduction disturbance.

  15. 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 ]
    Rates of onset of new atrial fibrillation or ventricular arrhythmia recorded by Watch.

  16. 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 ]
    Time of new atrial fibrillation or ventricular arrhythmia will record the time point of the onset of new atrial fibrillation or ventricular arrhythmia.

  17. Average daily step counts recorded by Watch [ Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    Average daily step counts recorded by Watch is one assessment of daily activity.

  18. 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 ]
    Moderate to vigorous physical activity time recorded by Watch is one assessment of daily activity.

  19. SpO2 detected by Watch [ Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    SpO2 detected by Watch

  20. Heart rate assessment recorded by Watch [ Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    Heart rate assessment includes average heart rate, resting heart rate, and premature beats ratio recorded by Watch

  21. Assessment of sleep reported by Watch [ Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up ]
    Assessment of sleep reported by Watch

  22. 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 ]
    Rates of cardiac event identified by the watch leading to change of therapy or intervention

  23. 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 ]
    Time of cardiac event identified by the watch leading to change of therapy or intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients aged 18 years or older who undergoing Transcatheter Aortic Valve Replacement were the initial target population.
Criteria

Inclusion Criteria:

  • At least 18 years old;
  • Be willing and able to provide informed consent to participate in the study;
  • Not share HUAWEI Watch, HUAWEI phone with anyone else;
  • Patient has severe aortic stenosis with echocardiographically derived criteria: mean gradient > 40mmHg or maximum velocity greater than 4.0 m/s or an initial aortic valve area of < 0.8cm2;
  • Patient who undergoing transfemoral transcatheter aortic valve replacement.

Exclusion Criteria:

  • Severe complications of TAVR, such as death, and conversion to SAVR;
  • Life expectancy is less than 12 months due to non-heart disease (such as cancer, chronic liver disease, chronic kidney disease, or chronic end-stage lung disease, etc.);
  • Severe dementia (cannot sign research informed consent, cannot take care of themselves or complete the study visit);
  • The investigator believes that the patient is not suitable to participate in the study or complete the follow-up prescribed by the protocol from other medical, social and psychological aspects;
  • The patient is currently participating in another randomized study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04454177


Contacts
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Contact: Jiaqi Fan, MD +86-15267029492 fanjiaqi@zju.edu.cn
Contact: Xianbao Liu, MD, PhD +86-13857173887 liuxb2009@hotmail.com

Locations
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China, Zhejiang
Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Xianbao Liu, MD, PhD    +86-13857173887    liuxb2009@hotmail.com   
Contact: Jiaqi Fan, MD    +86-15267029492    fanjiaqi@zju.edu.cn   
Principal Investigator: Jian-an Wang, MD, PhD         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Jian-an Wang, MD, PhD Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04454177    
Other Study ID Numbers: 2020-330
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Aortic Valve Stenosis
Heart Valve Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction