Quality of Care in AS IMPULSE Study

Study Overview
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Brief Summary
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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
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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

Official Title
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Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry

Conditions
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Aortic Valve Stenosis

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation<br>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 | |
| Early information<br>in this arm, 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Referral rates at 3 months for Intervention (SAVR or TAVI) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Referral rates at 3 months for exercise testing or stress echocardiography |  | 3 months | 
| Time to next out-patient appointment or clinical review |  | 15 months | 
| Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment) |  | 3 months | 
| Appropriateness of treatment decisions made in collaboration with the valve specialist |  | 3 months | 
| Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve Stenosis, Echo, TAVI, SAVR, referral