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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Composite of Death and Rehospitalization [Срок оценки: 30-day]
• Days Alive and Out of Hospital (DAOH) [Срок оценки: 30-day]

Вторичные конечные точки (12)

• Composite of Death and Rehospitalization [Срок оценки: 1-year, 2-year, and 3-year at follow-up]
• Days Alive and Out of Hospital (DAOH) [Срок оценки: 1-year, 2-year, and 3-year at follow-up]
• Incidence of pacemaker implantation [Срок оценки: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up]
• Time of pacemaker implantation [Срок оценки: 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up]
• New York Heart Association (NYHA) Functional Class [Срок оценки: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up]
• Kansas City Cardiomyopathy Questionnaire (KCCQ) [Срок оценки: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up]
• Hemoglobin [Срок оценки: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up]
• Pro-BNP [Срок оценки: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up]
• Albumin [Срок оценки: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up]
• Creatinine [Срок оценки: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up]
• Echocardiography examinations [Срок оценки: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up]
• Computed tomography examinations [Срок оценки: baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Second Affiliated Hospital, School of Medicine, Zhejiang University — Ханчжоу

Публикации

• 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

Идентификаторы

NCT: NCT04454177 · 2020-330

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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