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Aortic StenosisSMART TAVRNCT04454177

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

An observational study of Aortic Stenosis and Valvular Heart Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HUAWEI watch
Type of treatment
Medical device
How many people
100 participants
Where
1 siteChina
Study dates
15 Jul 2020to 1 Jul 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jiaqi Fan, MD contact

+86-15267029492

fanjiaqi@zju.edu.cn

Xianbao Liu, MD, PhD contact

+86-13857173887

liuxb2009@hotmail.com

China1 site, 1 recruiting

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310000

    Xianbao Liu, MD, PhD, +86-13857173887, liuxb2009@hotmail.com

    Jiaqi Fan, MD, +86-15267029492, fanjiaqi@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
HUAWEI watch
Medical subject headings
Aortic Valve Stenosis, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HUAWEI watchDevice

    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.

Study groups in NCT04454177
Study groupRoleWhat they receive
SMART watchMedical records from patients aged 18 years or older undergoing Transcatheter Aortic Valve Replacement
Receives: Device: HUAWEI watch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30-day

  2. 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.

    Measured: 30-day

Secondary outcomes (23)

  1. 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.

    Measured: 1-year, 2-year, and 3-year at follow-up

  2. 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.

    Measured: 1-year, 2-year, and 3-year at follow-up

  3. Incidence of pacemaker implantation

    Incidence of pacemaker implantation.

    Measured: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  4. Time of pacemaker implantation

    Time of pacemaker implantation will record the time point of the pacemaker implantation.

    Measured: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  5. 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.

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  6. 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.

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  7. Hemoglobin

    Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Hemoglobin is mg/dL.

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  8. Pro-BNP

    Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Pro-BNP is pg/mL.

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  9. Albumin

    Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Albumin is g/L.

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  10. Creatinine

    Laboratory examination include hemoglobin, pro-BNP, albumin, creatinine. The unit of Creatinine of umol/L.

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  11. 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.

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  12. Computed tomography examinations

    computed tomography examinations include CT assessment parameters, like annular area, perimeter, diameter, SOV, and Coronary height.

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  13. Rates of onset of conduction disturbance recorded by Watch

    Rates of onset of conduction disturbance recorded by Watch

    Measured: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  14. 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.

    Measured: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  15. 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.

    Measured: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  16. 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.

    Measured: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  17. Average daily step counts recorded by Watch

    Average daily step counts recorded by Watch is one assessment of daily activity.

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  18. Moderate to vigorous physical activity time recorded by Watch

    Moderate to vigorous physical activity time recorded by Watch is one assessment of daily activity.

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  19. SpO2 detected by Watch

    SpO2 detected by Watch

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  20. Heart rate assessment recorded by Watch

    Heart rate assessment includes average heart rate, resting heart rate, and premature beats ratio recorded by Watch

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  21. Assessment of sleep reported by Watch

    Assessment of sleep reported by Watch

    Measured: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  22. 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

    Measured: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

  23. 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

    Measured: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2020
  2. Study start15 Jul 2020
  3. Primary completion31 Aug 2021 (estimated)
  4. Study completion1 Jul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04454177
Sponsor's protocol ID
2020-330
Acronym
SMART TAVR
Status last verified
Jun 2020
First submitted
23 Jun 2020
Last updated
27 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fan J, Dai H, Guo Y, Xu J, Wang L, Jiang J, Lin X, Li C, Zhou D, Li H, Liu X, Wang J. Smartwatch-Detected Arrhythmias in Patients After Transcatheter Aortic Valve Replacement (TAVR): Analysis of the SMART TAVR Trial. J Med Internet Res. 2024 Jul 19;26:e41843. doi: 10.2196/41843.

    PubMed 39028996

  • Fan J, Liu Q, Dai H, Zhou D, Guo Y, Xu J, Wang L, Hu P, Jiang J, Lin X, Li C, Liu X, Wang J. Daily Physical Activity Measured by Wearable Smartwatch for Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the SMART TAVR Study. Circ Cardiovasc Qual Outcomes. 2024 Jan;17(1):e010066. doi: 10.1161/CIRCOUTCOMES.123.010066. Epub 2023 Dec 13.

    PubMed 38088154

  • 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.

    PubMed 35347997

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Stenosis and Valvular Heart Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiaqi Fan, MD (+86-15267029492, fanjiaqi@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Death and Rehospitalization (time frame: 30-day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04454177, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.

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