An observational study in Aortic Valve Stenosis, sponsored by Aesculap AG. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Aesculap AG · Observational
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 198 is close to the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
adult patients
Exclusion Criteria:
Assessment of PremiCron suture for cardiac valve reconstruction and replacement
a composite endpoint of Myocardial infarction, Stroke, Mortality until discharge and rate of Endocarditis of the replaced / reconstructed valve until 6 months
a composite endpoint of * Myocardial infarction until discharge * Stroke until discharge * Mortality until discharge * Endocarditis of the replaced / reconstructed valve until 6 months
Time frame: from intervention up to 6 months postoperative
Comparison of mortality at different timepoints in postoperative course
Incidence of mortality until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of myocardial infarction (MI) at different timepoints in postoperative course
Incidence of myocardial infarction (MI) until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of stroke at different timepoints in postoperative course
Incidence of stroke until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of endocarditis of the replaced / reconstructed valve at different timepoints in postoperative course
Incidence of endocarditis of the replaced / reconstructed valve until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of superficial and deep chest wound infections valve at different timepoints in postoperative course
Incidence of superficial and deep chest wound infections until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of atrial fibrillation valve at different timepoints in postoperative course
Incidence of atrial fibrillation until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of renal failure at different timepoints in postoperative course
Incidence of renal failure until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of pneumonia at different timepoints in postoperative course
Incidence of pneumonia until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of mediastinitis at different timepoints in postoperative course
Incidence of mediastinitis until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Comparison of bleeding at different timepoints in postoperative course
Incidence of bleeding until discharge, 30 days and 6 months postop
Time frame: until discharge (approximately 10 days postoperative), 30 days and 6 months postop
Rate of adverse events
valve related reoperation, haemothorax, paravalvular leak, pacemaker insertion, embolism, valve insufficiency, gastrointestinal bleeding, surgery not valve related
Time frame: until 6 months postop
Length of intensive care unit stay
Number of days the patient has to stay in intensive care unit after intervention
Time frame: until discharge (approximately 10 days postoperative)
Length of hospital stay
Number of days the patient has to stay in hospital
Time frame: until discharge (approximately 10 days postoperative)
Intraoperative handling of the suture material
Intraoperative handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale), including pledget assessment
Time frame: intraoperative
Course of Health Status
EQ-5D is a standardized measure of health status developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D is designed for self-completion by respondents and it takes only a few minutes to complete. Instructions to respondents are included in the questionnaire. EQ-5D-5L consists of 2 pages - descriptive system and the EQ visual Analogue scale (EQ-VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the respondents self rated health on a 20 cm vertical , visual analogue scale with endpoints labelled "the best health you can imagine" and " the worst health you can imagine"
Time frame: until 6 months postoperative
Employment status
The employment status of the patient before / after the intervention to evaluate the influence of cardiac valve reconstruction or / and replacement on employment
Time frame: preoperative and 6 months postoperative
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Aesculap AG