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

SMART TAVR: 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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis; Transcatheter Aortic Valve Replacement; Valvular Heart Disease
• Intervention / Treatment: Device: HUAWEI watch

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jiaqi Fan, MD; Phone Number: +86-15267029492; Email: fanjiaqi@zju.edu.cn
• Study Contact Backup: Name: Xianbao Liu, MD, PhD; Phone Number: +86-13857173887; Email: liuxb2009@hotmail.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Jiaqi Fan, MD; Phone Number: +86-15267029492; Email: fanjiaqi@zju.edu.cn
      • Contact: Xianbao Liu, MD, PhD; Phone Number: +86-13857173887; Email: liuxb2009@hotmail.com
      • Principal Investigator: Jian-an Wang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients aged 18 years or older who undergoing Transcatheter Aortic Valve Replacement were the initial target population.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SMART watch; Medical records from patients aged 18 years or older undergoing Transcatheter Aortic Valve Replacement	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Incidence of pacemaker implantation	Incidence of pacemaker implantation.	30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
SpO2 detected by Watch	SpO2 detected by Watch	baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
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
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
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

General Publications

• Liu X, Fan J, Guo Y, Dai H, Xu J, Wang L, Hu P, Lin X, Li C, Zhou D, Li H, Wang J. Wearable Smartwatch Facilitated Remote Health Management for Patients Undergoing Transcatheter Aortic Valve Replacement. J Am Heart Assoc. 2022 Apr 5;11(7):e023219. doi: 10.1161/JAHA.121.023219. Epub 2022 Mar 29.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2020
• Primary Completion (ANTICIPATED): August 31, 2021
• Study Completion (ANTICIPATED): July 1, 2031

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (ACTUAL): July 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction; Heart Diseases; Aortic Valve Stenosis; Heart Valve Diseases
• Other Study ID Numbers: 2020-330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No