Severe Aortic Stenosis in Patients Referred for Valve Surgery

• Conditions: Aortic Stenosis; Symptomatic Aortic Stenosis; Valvular Heart Disease

• Registration Number: NCT01794832
• Lead Sponsor: Oslo University Hospital

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.

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2013-02-16
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-20
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Last Update Submitted: 2014-04-02
• Last Update Posted: 2014-04-03
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death due cardiovascular events	one year

Secondary Outcome Measures

Name	Time	Method
MACE ( Major cardiovascular events )	30 days	Cerebral complications (stroke/bleeding), bleeding, renal failure, arrythmias, needs for pacemaker, prolong ICU stay, wound infections

Trial Locations

Locations (1)

Oslo University hospital- Rikshospitalet; 🇳🇴 Oslo, Norway