Using SMART watches to monitor patients after heart valve replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Second Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Jian-an Wang, MD, PhD — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Jiaqi Fan, MD
• Email: fanjiaqi@zju.edu.cn
• Phone: +86-15267029492

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DELINEATE-Prospective: AI-assisted echocardiogram analysis for valve disease

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• Registry for patients undergoing Transcatheter Aortic Valve Replacement

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• Exercise and nutrition support before and after TAVI for older adults with aortic stenosis

  This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.

  Recruiting University Hospital of Ferrara · Ferrara, FE · NCT07895719

• SYMmetric Valve expansion to reduce hypoattenuated leaflet thickening after balloon-expandable TAVI

  This trial tests whether the Double-TAP post-dilatation strategy can reduce HALT and improve valve function in patients 70 or older undergoing balloon-expandable TAVI.

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• Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI

  This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.

  Recruiting Istanbul University - Cerrahpasa · Istanbul, Istanbul · NCT07794436

• Systematic 14-day ambulatory heart monitoring after TAVI

  After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.

  Recruiting Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Québec, Quebec · NCT07739316

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.