Study to Improve Outcomes in Aortic Stenosis

Study Overview
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Brief Summary
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Multi-centre, multi-national, observational, prospective registry in four central full access centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per hub (smaller hospitals / office based cardiologists (OBC) without access to surgical and percutaneous aortic valve (AV) interventions). The hypothesis is that the management of patients with severe AS will differ between sites with on-site access to all treatment modes and those without such facilities.

Detailed Description
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Data from existing studies indicate that the treatment pathways for patients with severe aortic stenosis with or without symptoms are insufficiently defined. This lack of definition can contribute both to delay in treatment and inappropriate treatment decisions. While this has been confirmed in hospitals with a full complement of treatment modalities for severe aortic stenosis, including surgery and percutaneous options, it is not known whether delay in treatment or appropriateness of treatment decisions are better or worse in smaller hospitals without equivalent on-site access. The aim of this study is to delineate the case load of patients with aortic stenosis, outline the management of these patients and determine appropriateness in participating centres with and without on-site access to surgery and percutaneous treatment.

Official Title
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IMPULSE Enhanced - Study to Improve Outcomes in Aortic Stenosis - International, Multi-centre, Prospective, Observational Cohort Study

Conditions
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Aortic Valve Stenosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 years identified on echocardiography with severe aortic stenosis, defined as at least one of: aortic valve area < 1 cm2 indexed valve area < 0.6 cm2/m2 maximum jet velocity > 4.0 m/sec mean transvalvular gradient > 40 mmHg Exclusion Criteria: non-severe aortic stenosis previous aortic valve repair

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| symptomatic AS<br>Patients diagnosed with severe aortic stenosis in echocardiography who display one or more of the following symptoms: exertional shortness of breath, chest pain, exertional dizziness or syncope. | |
| asymptomatic AS<br>Patients diagnosed with severe aortic stenosis in echocardiography who do not display symptoms | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Referral rates of intervention or conservative treatment in symptomatic severe AS (SAVR vs. TAVI vs. medical treatment) in different types of hospitals | The purpose of this study is to determine treatment pathways for patients with severe AS and to find out about the critical steps in this pathway with respect to the time-course and treatment decisions made. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transition of asymptomatic in symptomatic severe aortic stenosis (clinical evaluation of shortness of breath, chest pain and/or dizziness or syncope) | Time course for the transition from asymptomatic in symptomatic severe AS and analysis of multivariables predictors for the development of symptoms (based on echo data and comorbidities at baseline) | 12 months | 
| Outcomes (survival) (intervention vs. conservative treatment) | rates of death | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Care, aortic stenosis, transcatheter aortic valve implantation, surgical aortic valve replacement, facilitated data relay