The main objective is to assess the long-term quality of life, as assessed with the SF-36v2* Health Survey, mortality and the cardiac functions as assessed with an echocardiogram in asymptomatic patients with severe aortic stenosis. Moreover,…
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary Objective(s): The secondary objective is to depict the emanated
complications occurred during follow-up.
Background summary
Provide insight in aortic valve replacement in asymptomatic patients with
severe aortic stenosis.
Study objective
The main objective is to assess the long-term quality of life, as assessed with
the SF-36v2* Health Survey, mortality and the cardiac functions as assessed
with an echocardiogram in asymptomatic patients with severe aortic stenosis.
Moreover, complications during follow-up will be regarded as secondary
objective.
Study design
hospital-based retrospective/ prospective cohort study
Study burden and risks
The expected burden is that of emotional, while filling the SF-36v2* Health
Survey. However, organizational burden may also take place, (i.e. taking a day
off, planning the travel route). We anticipate that there will be no adverse
effect while performing the echocardiogram as the risk associated with an
echocardiogram is negligible. Further data will be collected through the use of
the hospital data systems, wherefore we are assured that this will not bring
any harm to the patient. Moreover, patients may have benefit knowing that there
is a potential chance in their cardiac hemodynamic as evaluated with an
echocardiogram, which may lead to an altered, improved treatment strategy
's Gravendijkwal 230
ROTTERDAM 3015 CE
NL
's Gravendijkwal 230
ROTTERDAM 3015 CE
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57943.078.16 |