Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2173 participants
OBSERVATIONAL
2014-08-08
2018-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Indexed aortic valve area \<0.6 cm/m2
* Maximum Jet velocity \> 4.0 m/sec
* Mean transvalvular gradient \> 40 mmHg
Exclusion Criteria
* Previous aortic valve replacement (AVR)
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Institut für Pharmakologie und Präventive Medizin
NETWORK
Responsible Party
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Principal Investigators
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Richard Steeds, MD
Role: PRINCIPAL_INVESTIGATOR
Queen Elizabeth Hospital, Birmingham, UK
Norbert Frey, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology and Angiology, University of Kiel, Germany
Davia Messika-Zeitoun, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Bichat, Paris FR
Locations
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Krankenhaus Hietzing
Vienna, , Austria
IKEM - Institute for Clinical and Experimental Medicine
Prague, , Czechia
Centre Hospitalier d'Annecy
Annecy, , France
Bichat Hospital
Paris, , France
Charité - Campus Benjamin Franklin
Berlin, , Germany
Herzzentrum Universitätsklinikum Köln
Cologne, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Westpfalz Klinikum
Kaiserslautern, , Germany
UKSK Campus Kiel, Klinik für Kardiologie und Angiologie
Kiel, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Städtisches Klinikum München
München, , Germany
Krankenhaus der Barmherzigen Brüder
Trier, , Germany
Università degli Studi di Bari Aldo Moro
Bari, , Italy
University "Magna Græcia" of Catanzaro
Catanzaro, , Italy
IRCCS San Matteo Hospital
Pavia, , Italy
Policlinico Umberto I Rom
Rome, , Italy
University of Torino
Torino, , Italy
AMC Medical Center
Amsterdam, , Netherlands
Santa Creu Barcelona
Barcelona, , Spain
UniversitätsSpital Zürich
Zurich, , Switzerland
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Bart Heart Center
London, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Countries
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References
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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.
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 Links
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Related Info
Related Info
Other Identifiers
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IMPULSE
Identifier Type: -
Identifier Source: org_study_id
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