Severe Aortic Stenosis in Patients Referred for Valve Surgery (SAS)
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|ClinicalTrials.gov Identifier: NCT01794832|
Recruitment Status : Unknown
Verified April 2014 by Amjad Iqbal Hussain, Oslo University Hospital.
Recruitment status was: Recruiting
First Posted : February 20, 2013
Last Update Posted : April 3, 2014
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|Condition or disease|
|Aortic Stenosis Valvular Heart Disease Symptomatic Aortic Stenosis|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||A Prospective Longitudinal Study of Severe Aortic Stenosis in Elderly and Outcome of Aortic Surgery.|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||June 2014|
Elderly with severe aortic stenosis
Patients with severe symptomatic aortic stenosis referred for consideration of surgical aortic valve replacement
- Death due cardiovascular events [ Time Frame: one year ]
- MACE ( Major cardiovascular events ) [ Time Frame: 30 days ]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 ]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 ]
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Patients above 18 years with symptomatic AS referred to preoperative examination.
- Exclusion: Patients who do not want to participate. Patients not able to speak and read Norwegian.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Amjad Iqbal Hussain, Md, Oslo University Hospital|
|Other Study ID Numbers:||
|First Posted:||February 20, 2013 Key Record Dates|
|Last Update Posted:||April 3, 2014|
|Last Verified:||April 2014|
Aortic valve surgery
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical
Aortic Valve Disease
Ventricular Outflow Obstruction