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

October 25, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jian-an Wang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite of Death and Rehospitalization
Time Frame: 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.
30-day
Days Alive and Out of Hospital (DAOH)
Time Frame: 30-day
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Composite of Death and Rehospitalization
Time Frame: 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.
1-year, 2-year, and 3-year at follow-up
Days Alive and Out of Hospital (DAOH)
Time Frame: 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.
1-year, 2-year, and 3-year at follow-up
Incidence of pacemaker implantation
Time Frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Incidence of pacemaker implantation.
30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Time of pacemaker implantation
Time Frame: 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.
30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
New York Heart Association (NYHA) Functional Class
Time Frame: 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.
baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 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.
baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Hemoglobin
Time Frame: 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.
baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Pro-BNP
Time Frame: 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.
baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Albumin
Time Frame: 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.
baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Creatinine
Time Frame: 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.
baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Echocardiography examinations
Time Frame: 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.
baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Computed tomography examinations
Time Frame: 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.
baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Rates of onset of conduction disturbance recorded by Watch
Time Frame: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
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 Frame: 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.
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
Time Frame: 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.
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 Frame: 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.
30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Average daily step counts recorded by Watch
Time Frame: 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.
baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Moderate to vigorous physical activity time recorded by Watch
Time Frame: 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.
baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
SpO2 detected by Watch
Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
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
Time Frame: 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
baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
Assessment of sleep reported by Watch
Time Frame: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up
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
Time Frame: 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
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 Frame: 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
30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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