Status:
RECRUITING
SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Aortic Stenosis
Valvular Heart Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 eval...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2031
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04454177
Start Date
July 15 2020
End Date
July 1 2031
Last Update
October 27 2020
Active Locations (1)
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1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000