Skip to content

Severe Aortic Stenosis in Patients Referred for Valve Surgery

A Prospective Longitudinal Study of Severe Aortic Stenosis in Elderly and Outcome of Aortic Surgery.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01794832
Acronym
SAS
Enrollment
500
Registered
2013-02-20
Start date
2010-02-28
Completion date
2014-06-30
Last updated
2014-04-03

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

Conditions

Aortic Stenosis, Symptomatic Aortic Stenosis, Valvular Heart Disease

Keywords

HRQoL, Aortic stenosis, Aortic valve surgery

Brief summary

Our main hypothesis on the present study is that new parameters such as risk-taking behavior, patients motivation, health related quality of life, new biomarkers and more precise echocardiography measures in addition to traditional parameters will improve pre-operative risk assessment in patients with AS and better guide patients and doctors in decision whether to operate or not.

Detailed description

Patients referred for surgery are included thorough reading referral letter. Data collected in the study wil be compared with data from Medical records and clinical examination. Data entered will be controlled by two investigators. Data wil be compared to national norms and from result of other studies.

Interventions

None listed

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients above 18 years with symptomatic AS referred to preoperative examination.

Exclusion criteria

* Exclusion: Patients who do not want to participate. Patients not able to speak and read Norwegian.

Design outcomes

Primary

MeasureTime frame
Death due cardiovascular eventsone year

Secondary

MeasureTime frameDescription
MACE ( Major cardiovascular events )30 daysCerebral complications (stroke/bleeding), bleeding, renal failure, arrythmias, needs for pacemaker, prolong ICU stay, wound infections

Other

MeasureTime frameDescription
Change in Health related Quality and function one year after inclusionone yearPatients in the study perform Short Form-36, EuroQual-5D at inclusion and one year after. We want to compare the result of their scoring to obtain the gain in HRQoL of the intervention
Hospital visit and use of Health services last years30 days

Countries

Norway

Contacts

Primary ContactAmjad I Hussain, Md
amhu@ous-hf.no0047 98043412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026