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

Quality of life in asymptomatic patients with severe aortic stenosis; up to 10-years of follow-up - AVARIJN 2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43077

Enrollment

Registered

2016-10-10

Start date

2017-05-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aortic valve stenosis

Interventions

open heart surgery

severe aortic valve stenosis

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patients who are not able to give informed consent

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary Objective(s): The secondary objective is to depict the emanated complications occurred during follow-up.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)