Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
- Enrollment
- 2173
- Locations
- 23
- Primary Endpoint
- Referral rates at 3 months for Intervention (SAVR or TAVI)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to narrow the gap between patients being diagnosed with severe aortic stenosis and those being appropriately monitored and treated. For this purpose a prospective survey of current practice (3 months) will be conducted followed by a six month period of intervention during which a variety of quality improvements measures will be implemented. There will then be a 3 month follow-up period during which the legacy of this initiative will be monitored during which no intervention will be carried out.
Detailed Description
All patients meeting pre-specified criteria (severe aortic stenosis whether with or without symptoms) will be collected. There will be three phases at each site observation A, intervention, observation B. Observation A: In this phase, the nurse identifies cases with severe AS and collects their data. Baseline data for each patient will be collected and a follow-up will be done after three months for each patient to determine his/her outcome and the treatment that was decided on. There will also be an optional telephone follow-up to find out the patient's outcome. Intervention: In this phase, the physician referring a patient for echocardiography will be notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the attention of the referring physician within a week (via phone, e-mail or letter) to make them aware of the diagnosis. Baseline and follow-up data will be collected for each patient as before. Moreover, more detailed data with regard to the patient's health status will be documented. Observation B: Same as Observation Phase A
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aortic valve area \< 1cm2
- •Indexed aortic valve area \<0.6 cm/m2
- •Maximum Jet velocity \> 4.0 m/sec
- •Mean transvalvular gradient \> 40 mmHg
Exclusion Criteria
- •Non-severe aortic Stenosis (AS)
- •Previous aortic valve replacement (AVR)
Outcomes
Primary Outcomes
Referral rates at 3 months for Intervention (SAVR or TAVI)
Time Frame: 3 months
Secondary Outcomes
- Time to next out-patient appointment or clinical review(15 months)
- Appropriateness of treatment decisions made in collaboration with the valve specialist(3 months)
- Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment)(3 months)
- Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment(3 months)
- Referral rates at 3 months for exercise testing or stress echocardiography(3 months)