We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

Severe Aortic Stenosis in Patients Referred for Valve Surgery (SAS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Amjad Iqbal Hussain, Oslo University Hospital.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: February 20, 2013
Last Update Posted: April 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amjad Iqbal Hussain, Oslo University Hospital
February 16, 2013
February 20, 2013
April 3, 2014
February 2010
April 2014   (Final data collection date for primary outcome measure)
Death due cardiovascular events [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT01794832 on ClinicalTrials.gov Archive Site
MACE ( Major cardiovascular events ) [ Time Frame: 30 days ]
Cerebral complications (stroke/bleeding), bleeding, renal failure, arrythmias, needs for pacemaker, prolong ICU stay, wound infections
Cerebrovascular events du to surgical interventions [ Time Frame: 30 days ]
  • 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 ]
Kidney failure due surgical intervention [ Time Frame: 30 days ]
Severe Aortic Stenosis in Patients Referred for Valve Surgery
A Prospective Longitudinal Study of Severe Aortic Stenosis in Elderly and Outcome of Aortic Surgery.
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.

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.

Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
1 Year
Retention:   Samples With DNA
Serum, myocardial biopsi
Non-Probability Sample
Inclusion: Patients above 18 years with symptomatic AS referred to preoperative examination will be included. Patients will undergo standard investigations with regard to assessment of the clinical indication for operation
  • Aortic Stenosis
  • Valvular Heart Disease
  • Symptomatic Aortic Stenosis
Not Provided
Elderly with severe aortic stenosis
Patients with severe symptomatic aortic stenosis referred for consideration of surgical aortic valve replacement
Hussain AI, Garratt AM, Brunborg C, Aakhus S, Gullestad L, Pettersen KI. Eliciting Patient Risk Willingness in Clinical Consultations as a Means of Improving Decision-Making of Aortic Valve Replacement. J Am Heart Assoc. 2016 Mar 18;5(3):e002828. doi: 10.1161/JAHA.115.002828.
Unknown status
June 2014
April 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Amjad Iqbal Hussain, Oslo University Hospital
Oslo University Hospital
Not Provided
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
Oslo University Hospital
April 2014