Quality of Care in AS IMPULSE Study
- Conditions
- Aortic Valve Stenosis
- Registration Number
- NCT02241447
- Lead Sponsor
- Institut für Pharmakologie und Präventive Medizin
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2173
- Aortic valve area < 1cm2
- Indexed aortic valve area <0.6 cm/m2
- Maximum Jet velocity > 4.0 m/sec
- Mean transvalvular gradient > 40 mmHg
- Non-severe aortic Stenosis (AS)
- Previous aortic valve replacement (AVR)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Referral rates at 3 months for Intervention (SAVR or TAVI) 3 months
- Secondary Outcome Measures
Name Time Method Time to next out-patient appointment or clinical review 15 months Appropriateness of treatment decisions made in collaboration with the valve specialist 3 months Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment) 3 months Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment 3 months Referral rates at 3 months for exercise testing or stress echocardiography 3 months
Trial Locations
- Locations (23)
IKEM - Institute for Clinical and Experimental Medicine
🇨🇿Prag, Czechia
Westpfalz Klinikum
🇩🇪Kaiserslautern, Germany
Herzzentrum Universitätsklinikum Köln
🇩🇪Köln, Germany
IRCCS San Matteo Hospital
🇮🇹Pavia, Italy
Policlinico Umberto I Rom
🇮🇹Rom, Italy
University of Torino
🇮🇹Torino, Italy
Santa Creu Barcelona
🇪🇸Barcelona, Spain
AMC Medical Center
🇳🇱Amsterdam, Netherlands
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
Bart Heart Center
🇬🇧London, United Kingdom
Krankenhaus Hietzing
🇦🇹Wien, Austria
Centre Hospitalier d'Annecy
🇫🇷Annecy, France
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Bichat Hospital
🇫🇷Paris, France
Charité - Campus Benjamin Franklin
🇩🇪Berlin, Germany
UKSK Campus Kiel, Klinik für Kardiologie und Angiologie
🇩🇪Kiel, Germany
Städtisches Klinikum München
🇩🇪München, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Krankenhaus der Barmherzigen Brüder
🇩🇪Trier, Germany
Università degli Studi di Bari Aldo Moro
🇮🇹Bari, Italy
University "Magna Græcia" of Catanzaro
🇮🇹Catanzaro, Italy
UniversitätsSpital Zürich
🇨🇭Zürich, Switzerland