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

Recruiting now

Conditions studied: Aortic Stenosis, Valvular Heart Disease, Transcatheter Aortic Valve Replacement

In brief

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.

Key facts

Study ID

NCT04454177

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

100

Starts

2020-07-15

Expected to finish

2031-07-01

Last updated by the study team

2020-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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