Quality of life in asymptomatic patients with severe aortic stenosis; up to 10-years of follow-up

Completed

• Conditions: aortic valve stenosis; 10046973; 10007593

• Registration Number: NL-OMON43077
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

- Adult patients, mentally competent and 18 years of age or older
- Inclusion in the AVARIJN study;* Echocardiographic criteria:
- Aortic valve area <=1 cm2
- Maximal trans aortic jet velocity >=4 m/s
- Aortic valve / left ventricular outflow tract velocity time integral ratio >=4;* Signed informed consent by patient and investigator

Exclusion Criteria

Patients who are not able to give informed consent

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective(s): The primary objective is to determine the quality of life<br /><br>assessed with the SF-36V2* questionnaire in asymptomatic patients with severe<br /><br>aortic stenosis, the mortality (all-cause and specific cause) as well as the<br /><br>determination of the aortic valve function by an echocardiogram.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s): The secondary objective is to depict the emanated<br /><br>complications occurred during follow-up. </p><br>