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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| symptomatic AS | 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 | Patients diagnosed with severe aortic stenosis in echocardiography who do not display symptoms |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged over 18years identified on echocardiography with severe AS (irrespective of symptoms).
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Balduss, Prof | University of Cologne | Study Chair |
| Norbert Frey, Prof | University of Kiel, Germany | Study Chair |
| Richard Steeds, Prof | Queen Elizabeth Hospital, Birmingham, UK | Study Chair |
| David Messika-Zeitoun, Prof | Bichat Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bichat Hospital Paris | Paris | 75018 | France | |||
| Department of Cardiology and Angiology, University of Kiel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36657962 | Derived | Rudolph TK, Messika-Zeitoun D, Frey N, Lutz M, Krapf L, Passefort S, Fryearson J, Simpson H, Mortensen K, Rehse S, Tiroke A, Dodos F, Mies F, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Steeds RP; IMPULSE enhanced investigators. Severe aortic stenosis management in heart valve centres compared with primary/secondary care centres. Heart. 2023 May 26;109(12):944-950. doi: 10.1136/heartjnl-2022-321566. | |
| 31413844 |
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no sharing of individual patient data is planned
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Outcomes (survival) (intervention vs. conservative treatment) | rates of death | 12 months |
| Kiel |
| Schleswig-Holstein |
| 24105 |
| Germany |
| Derived |
| Rudolph TK, Messika-Zeitoun D, Frey N, Lutz M, Krapf L, Passefort S, Fryearson J, Simpson H, Mortensen K, Rehse S, Tiroke A, Dodos F, Mies F, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Steeds RP. Caseload management and outcome of patients with aortic stenosis in primary/secondary versus tertiary care settings-design of the IMPULSE enhanced registry. Open Heart. 2019 Jul 21;6(2):e001019. doi: 10.1136/openhrt-2019-001019. eCollection 2019. |
| D014694 |
| Ventricular Outflow Obstruction |