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

Aortic Stenosis Clinical Trial

— SMART TAVR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04454177
• Other study ID #: 2020-330
• Status: Recruiting
• Start date: July 15, 2020
• Est. completion date: July 1, 2031

Study information

• Verified date: June 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jiaqi Fan, MD
• Phone: +86-15267029492
• Email: fanjiaqi[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2031
• Est. primary completion date: August 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Heart Diseases
• Heart Valve Diseases
• Transcatheter Aortic Valve Replacement
• Valvular Heart Disease

Intervention

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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30-day
Primary	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.	30-day
Secondary	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.	1-year, 2-year, and 3-year at follow-up
Secondary	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.	1-year, 2-year, and 3-year at follow-up
Secondary	Incidence of pacemaker implantation	Incidence of pacemaker implantation.	30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	Time of pacemaker implantation	Time of pacemaker implantation will record the time point of the pacemaker implantation.	30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	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.	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	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.	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	Hemoglobin	Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Hemoglobin is mg/dL.	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	Pro-BNP	Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Pro-BNP is pg/mL.	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	Albumin	Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Albumin is g/L.	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	Creatinine	Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Creatinine of umol/L.	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	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.	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	Computed tomography examinations	computed tomography examinations include CT assessment parameters, like annular area, perimeter, diameter, SOV, and Coronary height.	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	Rates of onset of conduction disturbance recorded by Watch	Rates of onset of conduction disturbance recorded by Watch	30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	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.	30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	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.	30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	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.	30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	Average daily step counts recorded by Watch	Average daily step counts recorded by Watch is one assessment of daily activity.	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	Moderate to vigorous physical activity time recorded by Watch	Moderate to vigorous physical activity time recorded by Watch is one assessment of daily activity.	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	SpO2 detected by Watch	SpO2 detected by Watch	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	Heart rate assessment recorded by Watch	Heart rate assessment includes average heart rate, resting heart rate, and premature beats ratio recorded by Watch	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	Assessment of sleep reported by Watch	Assessment of sleep reported by Watch	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	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	30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Secondary	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	30-day, 6-month, 1-year, 2-year, and 3-year at follow-up