Study on the evaluation of the optimal timing of intervention in patients with combined aortic stenosis and mitral insufficiency
Summary description of the study
The aim of this study is to investigate the safety and efficacy of an earlier versus a later intervention on the aortic valve, in patients with moderate aortic stenosis, who also have significant leakage of another heart valve (the so-called mitral valve).
(BASEC)
Intervention under investigation
In our research project, we want to find out whether patients with aortic stenosis, who also have leakage of another heart valve (the so-called mitral valve), benefit from earlier treatment of the aortic valve.
(BASEC)
Disease under investigation
Moderate aortic stenosis and additionally at least one moderate mitral insufficiency
(BASEC)
- Moderate aortic stenosis - At least one moderate mitral insufficiency - At least 18 years old (BASEC)
Exclusion criteria
- Life expectancy of less than one year - Too low left ventricular ejection fraction (<30% or LVESD >70mm) (BASEC)
Trial sites
Bern, Geneva, Zurich
(BASEC)
Sponsor
Insel Gruppe AG Inselspital Bern Universitätsklinik für Kardiologie
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Thomas Pilgrim
0041 31 632 50 00
kardio.studien@clutterinsel.chInselspital Bern Medizinbereich Herz/Gefäss Freiburgstrasse 3010 Bern
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
20.04.2022
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with mitral regurgitation: a randomized clinical trial (BASEC)
Academic title
not available
Public title
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Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
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Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available