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

NCT04454177 | Recruiting

• 1 other identifier: 2020-330
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis; Valvular Heart Disease; Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (2)

• Composite of Death and Rehospitalization

  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.

  30-day

• Days Alive and Out of Hospital (DAOH)

  Kaplan-Meier Estimate of Days Alive and Out of Hospital (DAOH) from date of discharge, compared to a historical control.

  30-day

Secondary Outcomes (23)

• Composite of Death and Rehospitalization

  1-year, 2-year, and 3-year at follow-up

• Days Alive and Out of Hospital (DAOH)

  1-year, 2-year, and 3-year at follow-up

• Incidence of pacemaker implantation

  30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

• Time of pacemaker implantation

  30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

• New York Heart Association (NYHA) Functional Class

  baseline, 30-day, 6-month, 1-year, 2-year, and 3-year at follow-up

Study Arms (1)

SMART watch

Medical records from patients aged 18 years or older undergoing Transcatheter Aortic Valve Replacement

Device: HUAWEI watch

Interventions

HUAWEI watch DEVICE

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.

SMART watch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18 years or older who undergoing Transcatheter Aortic Valve Replacement were the initial target population.

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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (3)

• Fan J, Dai H, Guo Y, Xu J, Wang L, Jiang J, Lin X, Li C, Zhou D, Li H, Liu X, Wang J. Smartwatch-Detected Arrhythmias in Patients After Transcatheter Aortic Valve Replacement (TAVR): Analysis of the SMART TAVR Trial. J Med Internet Res. 2024 Jul 19;26:e41843. doi: 10.2196/41843.

  PMID: 39028996 DERIVED

• Fan J, Liu Q, Dai H, Zhou D, Guo Y, Xu J, Wang L, Hu P, Jiang J, Lin X, Li C, Liu X, Wang J. Daily Physical Activity Measured by Wearable Smartwatch for Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the SMART TAVR Study. Circ Cardiovasc Qual Outcomes. 2024 Jan;17(1):e010066. doi: 10.1161/CIRCOUTCOMES.123.010066. Epub 2023 Dec 13.

  PMID: 38088154 DERIVED

• Liu X, Fan J, Guo Y, Dai H, Xu J, Wang L, Hu P, Lin X, Li C, Zhou D, Li H, Wang J. Wearable Smartwatch Facilitated Remote Health Management for Patients Undergoing Transcatheter Aortic Valve Replacement. J Am Heart Assoc. 2022 Apr 5;11(7):e023219. doi: 10.1161/JAHA.121.023219. Epub 2022 Mar 29.

  PMID: 35347997 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Jian-an Wang, MD, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaqi Fan, MD

CONTACT

+86-15267029492; fanjiaqi@zju.edu.cn

Xianbao Liu, MD, PhD

CONTACT

+86-13857173887; liuxb2009@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 1, 2020
• Study Start: July 15, 2020
• Primary Completion: August 31, 2021
• Study Completion (Estimated): July 1, 2031
• Last Updated: October 27, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)