SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement
SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement
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.
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 < 1.0 cm2;

 -  Patient who undergoing elective 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.