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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | 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 | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Referral rates at 3 months for Intervention (SAVR or TAVI) | 3 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged over 18years identified on echocardiography with severe AS
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| Name | Affiliation | Role |
|---|---|---|
| Richard Steeds, MD | Queen Elizabeth Hospital, Birmingham, UK | Principal Investigator |
| Norbert Frey, MD | Department of Cardiology and Angiology, University of Kiel, Germany | Principal Investigator |
| Davia Messika-Zeitoun, MD | Hôpital Bichat, Paris FR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Hietzing | Vienna | 1130 | Austria | |||
| IKEM - Institute for Clinical and Experimental Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31549578 | Derived | Steeds RP, Lutz M, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Rudolph TK, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle-Karth G, Rieber J, Indolfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Frey N, Messika-Zeitoun D. Facilitated Data Relay and Effects on Treatment of Severe Aortic Stenosis in Europe. J Am Heart Assoc. 2019 Oct;8(19):e013160. doi: 10.1161/JAHA.119.013160. Epub 2019 Sep 24. | |
| 31302639 |
| Label | URL |
|---|---|
| Related Info | View source |
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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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| 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 |
| Prague |
| 140 21 |
| Czechia |
| Centre Hospitalier d'Annecy | Annecy | 74374 | France |
| Bichat Hospital | Paris | 75018 | France |
| Charité - Campus Benjamin Franklin | Berlin | 10233 | Germany |
| Herzzentrum Universitätsklinikum Köln | Cologne | 50924 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Westpfalz Klinikum | Kaiserslautern | 67655 | Germany |
| UKSK Campus Kiel, Klinik für Kardiologie und Angiologie | Kiel | 24105 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Städtisches Klinikum München | München | 80337 | Germany |
| Krankenhaus der Barmherzigen Brüder | Trier | 54292 | Germany |
| Università degli Studi di Bari Aldo Moro | Bari | 70121 | Italy |
| University "Magna Græcia" of Catanzaro | Catanzaro | 88100 | Italy |
| IRCCS San Matteo Hospital | Pavia | 27100 | Italy |
| Policlinico Umberto I Rom | Rome | 00161 | Italy |
| University of Torino | Torino | Italy |
| AMC Medical Center | Amsterdam | 1105 | Netherlands |
| Santa Creu Barcelona | Barcelona | 08025 | Spain |
| UniversitätsSpital Zürich | Zurich | 8091 | Switzerland |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Bart Heart Center | London | E1 1BB | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Derived |
| Frey N, Steeds RP, Rudolph TK, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle Karth G, Rieber J, Indorfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Lutz M, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Messika-Zeitoun D; IMPULSE registry group. Symptoms, disease severity and treatment of adults with a new diagnosis of severe aortic stenosis. Heart. 2019 Nov;105(22):1709-1716. doi: 10.1136/heartjnl-2019-314940. Epub 2019 Jul 13. |
| Related Info | View source |
| D014694 |
| Ventricular Outflow Obstruction |