SAS: Severe Aortic Stenosis in Patients Referred for Valve Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Elderly with severe aortic stenosis Patients with severe symptomatic aortic stenosis referred for consideration of surgical aortic valve replacement |
Outcome Measures
Primary Outcome Measures
- Death due cardiovascular events [one year]
Secondary Outcome Measures
- MACE ( Major cardiovascular events ) [30 days]
Cerebral complications (stroke/bleeding), bleeding, renal failure, arrythmias, needs for pacemaker, prolong ICU stay, wound infections
Other Outcome Measures
- Change in Health related Quality and function one year after inclusion [one year]
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 [30 days]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oslo University hospital- Rikshospitalet | Oslo | Norway |
Sponsors and Collaborators
- Oslo University Hospital
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAS