Timing an intervention for aortic stenosis with remote patient monitoring

Not Applicable

• Conditions: Remote monitoring of patients with aortic stenosis; Circulatory System

• Registration Number: ISRCTN19413194
• Lead Sponsor: niversity of Birmingham

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38858149/ (added 11/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-12
• Last Update Posted: 24 June 2024
• Study Completion: 2024-09-17

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Patients diagnosed with asymptomatic sAS of a native valve
2. Aortic valve area <1cm2 and mean pressure gradient >40mmHg and left ventricular ejection fraction (LVEF) >50% (in the last 6 months)
3. Able to give written informed consent
4. Aged =18 years old
5. Able to access and use app-based programmes (using the English language)

Exclusion Criteria

1. Lack of capacity to understand the nature of the study and possible consequences as assessed by their attending clinician
2. Significant disease of other valves e.g. mitral stenosis/regurgitation
3. Co-morbidities that in the opinion of the cardiac surgeon/cardiologist preclude successful valve intervention e.g. life expectancy of fewer than 2 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary measures are measured using data from the app at the conclusion of the follow-up period:<br>1. Assess the utility of the app” measured using quantitative app usage data and data completeness recorded in the app and qualitative interview data<br>2. Assess engagement with the intervention <br>3. Recruitment rate per month <br>4. Number of withdrawals and losses to follow up (with reasons)