Clinical trial NCT02241447: Quality of Care in AS IMPULSE Study
Official title: Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: aortic valve Stenosis
Echo
TAVI
SAVR
referral
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Edwards Lifesciences
First posted: 2014-09-16
Enrollment: 2173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged over 18years identified on echocardiography with severe AS

Brief summary: 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: 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

Eligibility criteria: 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)

Primary outcomes:
measure: Referral rates at 3 months for Intervention (SAVR or TAVI)
timeFrame: 3 months
Secondary outcomes:
measure: Referral rates at 3 months for exercise testing or stress echocardiography
timeFrame: 3 months
measure: Time to next out-patient appointment or clinical review
timeFrame: 15 months
measure: Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment)
timeFrame: 3 months
measure: Appropriateness of treatment decisions made in collaboration with the valve specialist
timeFrame: 3 months
measure: Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Krankenhaus Hietzing
city: Prag
country: Czechia
facility: IKEM - Institute for Clinical and Experimental Medicine
city: Annecy
country: France
facility: Centre Hospitalier d'Annecy
city: Paris
country: France
facility: Bichat Hospital
city: Berlin
country: Germany
facility: Charité - Campus Benjamin Franklin
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Kaiserslautern
country: Germany
facility: Westpfalz Klinikum
city: Kiel
country: Germany
facility: UKSK Campus Kiel, Klinik für Kardiologie und Angiologie
city: Köln
country: Germany
facility: Herzzentrum Universitätsklinikum Köln
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: München
country: Germany
facility: Städtisches Klinikum München
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Bari
country: Italy
facility: Università degli Studi di Bari Aldo Moro
city: Catanzaro
country: Italy
facility: University "Magna Græcia" of Catanzaro
city: Pavia
country: Italy
facility: IRCCS San Matteo Hospital
city: Rom
country: Italy
facility: Policlinico Umberto I Rom
city: Torino
country: Italy
facility: University of Torino
city: Amsterdam
country: Netherlands
facility: AMC Medical Center
city: Barcelona
country: Spain
facility: Santa Creu Barcelona
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: Bart Heart Center
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
Study officials:
affiliation: Queen Elizabeth Hospital, Birmingham, UK
name: Richard Steeds, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology and Angiology, University of Kiel, Germany
name: Norbert Frey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Bichat, Paris FR
name: Davia Messika-Zeitoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.