SMART TAVR: SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Composite of Death and Rehospitalization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Composite of Death and Rehospitalization
时间窗: 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.
Days Alive and Out of Hospital (DAOH)
时间窗: 30-day
Kaplan-Meier Estimate of Days Alive and Out of Hospital (DAOH) from date of discharge, compared to a historical control.
次要结局
- Echocardiography examinations(baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up)
- Composite of Death and Rehospitalization(1-year, 2-year, and 3-year at follow-up)
- Days Alive and Out of Hospital (DAOH)(1-year, 2-year, and 3-year at follow-up)
- Creatinine(baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up)
- Hemoglobin(baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up)
- Average daily step counts recorded by Watch(baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up)
- Albumin(baseline, 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(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)
- Incidence of pacemaker implantation(30-day, 6-month, 1-year, 2-year, and 3-year at follow-up)
- Time of pacemaker implantation(30-day, 6-month, 1-year, 2-year, and 3-year at follow-up)
- Pro-BNP(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(30-day, 6-month, 1-year, 2-year, and 3-year at follow-up)
- New York Heart Association (NYHA) Functional Class(baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up)
- Computed tomography examinations(baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up)
- Heart rate assessment recorded by Watch(baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up)
- Moderate to vigorous physical activity time recorded by Watch(baseline, 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(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)
- SpO2 detected by Watch(baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up)