Clinical trial NCT04454177: SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement
Official title: SMART TAVR: SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis
Valvular Heart Disease
Transcatheter Aortic Valve Replacement
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older who undergoing Transcatheter Aortic Valve Replacement were the initial target population.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite of Death and Rehospitalization
timeFrame: 30-day
measure: Days Alive and Out of Hospital (DAOH)
timeFrame: 30-day
Secondary outcomes:
measure: Composite of Death and Rehospitalization
timeFrame: 1-year, 2-year, and 3-year at follow-up
measure: Days Alive and Out of Hospital (DAOH)
timeFrame: 1-year, 2-year, and 3-year at follow-up
measure: Incidence of pacemaker implantation
timeFrame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Time of pacemaker implantation
timeFrame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: New York Heart Association (NYHA) Functional Class
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Hemoglobin
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Pro-BNP
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Albumin
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Creatinine
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Echocardiography examinations
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Computed tomography examinations
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Rates of onset of conduction disturbance recorded by Watch
timeFrame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Time of onset of conduction disturbance recorded by Watch
timeFrame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Rates of onset of new atrial fibrillation or ventricular arrhythmia recorded by Watch
timeFrame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Time of onset of new atrial fibrillation or ventricular arrhythmia recorded by Watch
timeFrame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Average daily step counts recorded by Watch
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Moderate to vigorous physical activity time recorded by Watch
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: SpO2 detected by Watch
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Heart rate assessment recorded by Watch
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Assessment of sleep reported by Watch
timeFrame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Rates of cardiac event identified by the watch leading to change of therapy or intervention
timeFrame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
measure: Time of cardiac event identified by the watch leading to change of therapy or intervention
timeFrame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jian-an Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.