SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HUAWEI watch.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis, Valvular Heart Disease, Transcatheter Aortic Valve Replacement. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SMART TAVR: SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement
Overview
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.
Interventions
- 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.
Primary outcome measures
- Composite of Death and Rehospitalization [Time frame: 30-day]
- Days Alive and Out of Hospital (DAOH) [Time frame: 30-day]
Secondary outcome measures (12)
- Composite of Death and Rehospitalization [Time frame: 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]
- Incidence of pacemaker implantation [Time frame: 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]
- New York Heart Association (NYHA) Functional Class [Time frame: 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]
- Hemoglobin [Time frame: 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]
- Albumin [Time frame: 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]
- Echocardiography examinations [Time frame: 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
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. PMID 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. PMID 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. PMID 35347997
Identifiers
NCT: NCT04454177 · 2020-330