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

Recruiting

• Conditions: Valvular Heart Disease; Transcatheter Aortic Valve Replacement; Aortic Stenosis
• Interventions: Device: HUAWEI watch

• Registration Number: NCT04454177
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-01
• Study Start: 2020-07-15
• Last Update Submitted: 2020-10-25
• Last Update Posted: 2020-10-27
• Primary Completion: 2021-08-31
• Study Completion: 2031-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SMART watch	HUAWEI watch	Medical records from patients aged 18 years or older undergoing Transcatheter Aortic Valve Replacement

Primary Outcome Measures

Name	Time	Method
Composite of Death and Rehospitalization	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.
Days Alive and Out of Hospital (DAOH)	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

Name	Time	Method
Echocardiography examinations	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.
Composite of Death and Rehospitalization	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.
Days Alive and Out of Hospital (DAOH)	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.
Creatinine	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.
Kansas City Cardiomyopathy Questionnaire (KCCQ)	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.
Hemoglobin	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.
Albumin	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.
Rates of onset of conduction disturbance recorded by Watch	30-day, 6-month, 1-year, 2-year, and 3-year at follow-up	Rates of onset of conduction disturbance recorded by Watch
Time of onset of conduction disturbance recorded by Watch	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.
Rates of onset of new atrial fibrillation or ventricular arrhythmia recorded by Watch	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.
Incidence of pacemaker implantation	30-day, 6-month, 1-year, 2-year, and 3-year at follow-up	Incidence of pacemaker implantation.
Time of pacemaker implantation	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.
Pro-BNP	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.
Average daily step counts recorded by Watch	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.
Assessment of sleep reported by Watch	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up	Assessment of sleep reported by Watch
Rates of cardiac event identified by the watch leading to change of therapy or intervention	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
New York Heart Association (NYHA) Functional Class	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.
Computed tomography examinations	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.
Heart rate assessment recorded by Watch	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
Moderate to vigorous physical activity time recorded by Watch	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.
Time of cardiac event identified by the watch leading to change of therapy or intervention	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 onset of new atrial fibrillation or ventricular arrhythmia recorded by Watch	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.
SpO2 detected by Watch	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up	SpO2 detected by Watch

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China