About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 < 1.0 cm2;
Disqualifiers
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;
Trial population
Patients aged 18 years or older who undergoing Transcatheter Aortic Valve Replacement were the initial target population.
Trial design
Cohort
Prospective
Treatments tested in this trial
HUAWEI watch
DeviceHUAWEI 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
Incidence of pacemaker implantation
Incidence of pacemaker implantation.
Time of pacemaker implantation
Time of pacemaker implantation will record the time point of the pacemaker implantation.
Sponsors and contacts
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