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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • HUAWEI watch

    Device

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: SMART watch1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

Incidence of pacemaker implantation

Incidence of pacemaker implantation.

Time frame
30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
4

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

Other outcomes

Sponsors and contacts

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