NCT04454177 SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement
| NCT ID | NCT04454177 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Aortic Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-07-15 |
| Primary Completion | 2021-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2020-07-15 with a primary completion date of 2021-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Jian-an Wang, MD, PhD
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT04454177 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04454177 currently recruiting?
Yes, NCT04454177 is actively recruiting participants. Contact the research team at fanjiaqi@zju.edu.cn for enrollment information.
Where is the NCT04454177 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT04454177 clinical trial?
NCT04454177 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Jian-an Wang, MD, PhD at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 100 participants.