Severe Aortic Stenosis in Patients Referred for Valve Surgery

Aortic Stenosis Clinical Trial

— SAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01794832
• Other study ID #: SAS
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2013
• Last updated: April 2, 2014
• Start date: February 2010
• Est. completion date: June 2014

Study information

• Verified date: April 2014
• Source: Oslo University Hospital
• Contact: Amjad I Hussain, Md
• Phone: 0047 98043412
• Email: amhu[@]ous-hf.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Heart Valve Diseases
• Symptomatic Aortic Stenosis
• Valvular Heart Disease

Locations

Country	Name	City	State
Norway	Oslo University hospital- Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Health related Quality and function one year after inclusion	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	one year	No
Other	Hospital visit and use of Health services last years		30 days	No
Primary	Death due cardiovascular events		one year	No
Secondary	MACE ( Major cardiovascular events )	Cerebral complications (stroke/bleeding), bleeding, renal failure, arrythmias, needs for pacemaker, prolong ICU stay, wound infections	30 days	No