PremiCron Suture for Cardiac Valve Repair
- Conditions
- Aortic Valve Stenosis
- Registration Number
- NCT04096859
- Lead Sponsor
- Aesculap AG
- Brief Summary
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
- Patients undergoing an elective primary open or minimal invasive surgery for a single or multiple cardiac valve reconstruction or / and replacement.
- Age ≥18 years
- Written informed consent
- Patients undergoing an elective primary cardiac valve reconstruction or / and replacement in combination with a coronary arterial bypass graft surgery.
- Emergency surgery
- Pregnancy
- Infective endocarditis
- Previous cardiac surgical intervention
- Known immunodeficiency or immunosuppression
- Participation or planned participation in another cardiovascular study before study follow-up is completed.
- Inability to give informed consent due to mental condition, mental retardation, or language barrier.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a composite endpoint of Myocardial infarction, Stroke, Mortality until discharge and rate of Endocarditis of the replaced / reconstructed valve until 6 months from intervention up to 6 months postoperative a composite endpoint of
* Myocardial infarction until discharge
* Stroke until discharge
* Mortality until discharge
* Endocarditis of the replaced / reconstructed valve until 6 months
- Secondary Outcome Measures
Name Time Method Comparison of renal failure at different timepoints in postoperative course until discharge (approximately 10 days postoperative), 30 days and 6 months postop Incidence of renal failure until discharge, 30 days and 6 months postop
Comparison of mortality at different timepoints in postoperative course until discharge (approximately 10 days postoperative), 30 days and 6 months postop Incidence of mortality until discharge, 30 days and 6 months postop
Comparison of stroke at different timepoints in postoperative course until discharge (approximately 10 days postoperative), 30 days and 6 months postop Incidence of stroke until discharge, 30 days and 6 months postop
Comparison of pneumonia at different timepoints in postoperative course until discharge (approximately 10 days postoperative), 30 days and 6 months postop Incidence of pneumonia until discharge, 30 days and 6 months postop
Comparison of atrial fibrillation valve at different timepoints in postoperative course until discharge (approximately 10 days postoperative), 30 days and 6 months postop Incidence of atrial fibrillation until discharge, 30 days and 6 months postop
Intraoperative handling of the suture material intraoperative Intraoperative handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale), including pledget assessment
Comparison of myocardial infarction (MI) at different timepoints in postoperative course until discharge (approximately 10 days postoperative), 30 days and 6 months postop Incidence of myocardial infarction (MI) until discharge, 30 days and 6 months postop
Rate of adverse events until 6 months postop valve related reoperation, haemothorax, paravalvular leak, pacemaker insertion, embolism, valve insufficiency, gastrointestinal bleeding, surgery not valve related
Employment status preoperative and 6 months postoperative The employment status of the patient before / after the intervention to evaluate the influence of cardiac valve reconstruction or / and replacement on employment
Comparison of endocarditis of the replaced / reconstructed valve at different timepoints in postoperative course until discharge (approximately 10 days postoperative), 30 days and 6 months postop Incidence of endocarditis of the replaced / reconstructed valve until discharge, 30 days and 6 months postop
Comparison of superficial and deep chest wound infections valve at different timepoints in postoperative course until discharge (approximately 10 days postoperative), 30 days and 6 months postop Incidence of superficial and deep chest wound infections until discharge, 30 days and 6 months postop
Comparison of mediastinitis at different timepoints in postoperative course until discharge (approximately 10 days postoperative), 30 days and 6 months postop Incidence of mediastinitis until discharge, 30 days and 6 months postop
Length of hospital stay until discharge (approximately 10 days postoperative) Number of days the patient has to stay in hospital
Course of Health Status until 6 months postoperative 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"
Comparison of bleeding at different timepoints in postoperative course until discharge (approximately 10 days postoperative), 30 days and 6 months postop Incidence of bleeding until discharge, 30 days and 6 months postop
Length of intensive care unit stay until discharge (approximately 10 days postoperative) Number of days the patient has to stay in intensive care unit after intervention
Trial Locations
- Locations (2)
Hospital de la Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Robert Bosch KH Stuttgart
🇩🇪Stuttgart, Germany