Daily Physical Activity Measured by Wearable Smartwatch for Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the SMART TAVR Study.
Jiaqi Fan, Qiong Liu, Hanyi Dai...
https://pubmed.ncbi.nlm.nih.gov/38088154/Actively Recruiting
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2020-10-27
100
Participants Needed
1
Research Sites
513 weeks
Total Duration
Researchers are observing patients who have undergone Transcatheter Aortic Valve Replacement TAVR to study conduction disturbances, daily activity levels, heart rates, and oxygen saturation. The study aims to evaluate how well the HUAWEI Watch can provide early warnings of changes in heart rate, rhythm, oxygen levels, activity, and sleep patterns after TAVR, especially in the setting of a new early discharge protocol. Patients will receive a HUAWEI Watch within 24 hours before their TAVR procedure. This device continuously tracks heart rate, step counts, sleep cycles, oxygen saturation, and certain heart rhythm features like QRS complexes and P waves. After TAVR, patients will follow a schedule of outpatient visits at 1, 6, 12, 24, and 36 months. They will use the watch to record biometric readings at least twice daily for the week after discharge, a few times weekly during the following month, and at least weekly thereafter. They also record readings during any cardiovascular symptoms. The collected health data is transmitted to a phone app and then securely stored and reviewed by a heart team member. The team monitors for concerning changes that may require further action. The study measures include death and rehospitalization rates, days alive and out of hospital within 30 days, and long-term follow-up of heart function, arrhythmias, physical activity, oxygen levels, and cardiac events over three years.
CONDITIONS
SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement
J
Jiaqi Fan, MD
X
Xianbao Liu, MD, PhD
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day before TAVR
Participants are assigned a HUAWEI Watch within 24 hours before the Transcatheter Aortic Valve Replacement (TAVR) procedure to monitor multiple biometric parameters.
1 visit (in-person)
Duration - Up to 36 months post-TAVR
Participants use the HUAWEI Watch to continuously monitor heart rate, step counts, sleep cycles, pulse oxygen saturation, and ECG readings. They activate watch readings at least twice daily for the first week after discharge, at least twice a week for the next month, and at least once weekly thereafter, including during any cardiovascular symptoms.
Outpatient clinic visits at 1, 6, 12, 24, and 36 months; ongoing remote monitoring via the watch
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Jiaqi Fan, Qiong Liu, Hanyi Dai...
https://pubmed.ncbi.nlm.nih.gov/38088154/Xianbao Liu, Jiaqi Fan, Yuchao Guo...
https://pubmed.ncbi.nlm.nih.gov/35347997/Jiaqi Fan, Hanyi Dai, Yuchao Guo...
https://pubmed.ncbi.nlm.nih.gov/39028996/Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor