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Clinical Trials/ISRCTN19413194
ISRCTN19413194
Active, not recruiting
未知

A pilot study to assess the safety, effectiveness and practical utility of remote patient monitoring to guide the timing of valve intervention in patients with asymptomatic severe aortic stenosis (APRAISE-AS)

niversity of Birmingham0 sites66 target enrollmentMay 12, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Remote monitoring of patients with aortic stenosis
Sponsor
niversity of Birmingham
Enrollment
66
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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

Registry
who.int
Start Date
May 12, 2023
End Date
September 17, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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