Using SMART watches to monitor patients after heart valve replacement

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

This study tests if using a HUAWEI smartwatch to track heart rate, oxygen levels, and activity can help patients who have had heart valve replacement spot problems early and recover better.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT04454177 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of the HUAWEI Watch in monitoring biometric parameters such as heart rate, oxygen saturation, and daily activity levels in patients who have undergone Transcatheter Aortic Valve Replacement (TAVR). Patients will wear the watch before and after the procedure to help identify any early warning signs of complications. The study will follow participants over a period of up to 36 months, with regular outpatient visits and data collection through the HUAWEI phone application. The goal is to assess how well this technology can facilitate early discharge and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with severe aortic stenosis undergoing elective transfemoral TAVR.

Not a fit: Patients with severe complications from TAVR or those with a life expectancy of less than 12 months due to non-heart disease conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer early discharges and better monitoring of patients after heart valve replacement.

How similar studies have performed: While the use of wearable technology in monitoring health is gaining traction, this specific application in TAVR patients is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Principal investigator: Jian-an Wang, MD, PhD — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Jiaqi Fan, MD

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