An observational study in Aortic Stenosis, Valvular Heart Disease and Transcatheter Aortic Valve Replacement, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 100 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 18 years or older who undergoing Transcatheter Aortic Valve Replacement were the initial target population.
Exclusion Criteria:
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.
Composite of Death and Rehospitalization
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.
Time frame: 30-day
Days Alive and Out of Hospital (DAOH)
Kaplan-Meier Estimate of Days Alive and Out of Hospital (DAOH) from date of discharge, compared to a historical control.
Time frame: 30-day
Composite of Death and Rehospitalization
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.
Time frame: 1-year, 2-year, and 3-year at follow-up
Days Alive and Out of Hospital (DAOH)
Kaplan-Meier Estimate of Days Alive and Out of Hospital (DAOH) from date of discharge, compared to a historical control.
Time frame: 1-year, 2-year, and 3-year at follow-up
Incidence of pacemaker implantation
Incidence of pacemaker implantation.
Time frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Time of pacemaker implantation
Time of pacemaker implantation will record the time point of the pacemaker implantation.
Time frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
New York Heart Association (NYHA) Functional Class
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.
Time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Hemoglobin
Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Hemoglobin is mg/dL.
Time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Pro-BNP
Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Pro-BNP is pg/mL.
Time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Albumin
Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Albumin is g/L.
Time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Creatinine
Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Creatinine of umol/L.
Time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Echocardiography examinations
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.
Time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Computed tomography examinations
computed tomography examinations include CT assessment parameters, like annular area, perimeter, diameter, SOV, and Coronary height.
Time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Rates of onset of conduction disturbance recorded by Watch
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
Time of onset of conduction disturbance recorded by Watch
Time of onset of conduction disturbance will record the time point of the onset of conduction disturbance.
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
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
Time of onset of new atrial fibrillation or ventricular arrhythmia recorded by Watch
Time of new atrial fibrillation or ventricular arrhythmia will record the time point of the onset of new atrial fibrillation or ventricular arrhythmia.
Time frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Average daily step counts recorded by Watch
Average daily step counts recorded by Watch is one assessment of daily activity.
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
Moderate to vigorous physical activity time recorded by Watch is one assessment of daily activity.
Time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
SpO2 detected by Watch
SpO2 detected by Watch
Time frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Heart rate assessment recorded by Watch
Heart rate assessment includes average heart rate, resting heart rate, and premature beats ratio recorded 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
Assessment of sleep reported by Watch
Time frame: baseline, 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
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
Time of cardiac event identified by the watch leading to change of therapy or intervention
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
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Second Affiliated Hospital, School of Medicine, Zhejiang University