Severe Aortic Stenosis in Patients Referred for Valve Surgery (SAS)
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.
Valvular Heart Disease
Symptomatic Aortic Stenosis
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration:||1 Year|
|Official Title:||A Prospective Longitudinal Study of Severe Aortic Stenosis in Elderly and Outcome of Aortic Surgery.|
- Death due cardiovascular events [ Time Frame: one year ] [ Designated as safety issue: No ]
- MACE ( Major cardiovascular events ) [ Time Frame: 30 days ] [ Designated as safety issue: No ]Cerebral complications (stroke/bleeding), bleeding, renal failure, arrythmias, needs for pacemaker, prolong ICU stay, wound infections
- Change in Health related Quality and function one year after inclusion [ Time Frame: one year ] [ Designated as safety issue: No ]Patients 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 years [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Serum, myocardial biopsi
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Elderly with severe aortic stenosis
Patients with severe symptomatic aortic stenosis referred for consideration of surgical aortic valve replacement
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794832
|Contact: Amjad I Hussain, Md||0047 firstname.lastname@example.org|
|Oslo University hospital- Rikshospitalet||Recruiting|
|Contact: Lars Gullestad, professor email@example.com|
|Principal Investigator: Amjad Iqbal Hussain|
|Principal Investigator: Andreas Auensen, Md|
|Study Director:||Kjell I Pettersen, MD||University of Oslo|
|Principal Investigator:||Amjad I Hussain, MD||Oslo University Hosptial|
|Study Chair:||Lars Gullestad, Professor||Oslo University Hospital|