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Clinical Trials in China / NCT04454177
Recruiting Observational

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

NCT04454177 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2020-07-15
Last updated
2020-10-27

Condition(s) studied

Aortic StenosisValvular Heart DiseaseTranscatheter Aortic Valve Replacement

Investigational drug(s) / intervention(s)

HUAWEI watch

HUAWEI watch: HUAWEI Watch will be assigned to patients within 24 hours before TAVR. HUAWEI Watch GT series can continuously monitor and record multiple biometric parameters heart rate, step counts, sleep cycles and can detect and record the pulse oxygen saturation, as well as analyze QRS complexes and P waves after triggering.

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Composite of Death and Rehospitalization — 30-day
    Kaplan-Meier Estimate of Death or Rehospitalization from date of discharge, compared to a historical control. Rehospitalization is defined as any hospitalization related to the procedure, the valve or heart failure.
  • Days Alive and Out of Hospital (DAOH) — 30-day
    Kaplan-Meier Estimate of Days Alive and Out of Hospital (DAOH) from date of discharge, compared to a historical control.

Trial sites (1)

FacilityCityRegionStatus
Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang Recruiting

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Other trials for the same condition

Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA Enrolling by invitation
Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University Recruiting
Mechanism and Effect of Novel Metabolites on Valvular Heart Disease Recruiting
Can a Smartphone Listen to Your Heart? A Performance Study on Detecting Abnormalities in Your Heart Sounds Active, not recruiting
TAVR for Aortic Regurgitation Under TEE Guidance Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04454177 on ClinicalTrials.gov ↗ ← All trials in China