PremiCron Suture for Cardiac Valve Repair

Study Overview
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Brief Summary
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The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.

Official Title
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Assessment of PremiCron Suture for Cardiac Valve Reconstruction and Replacement. A Multi-centric, Prospective, Single Arm Observational Study in Daily Practice.

Conditions
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Aortic Valve Stenosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PremiCron®<br>Assessment of PremiCron suture for cardiac valve reconstruction and replacement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | from intervention up to 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of mortality at different timepoints in postoperative course | Incidence of mortality until discharge, 30 days and 6 months postop | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | until 6 months postop | 
| Length of intensive care unit stay | Number of days the patient has to stay in intensive care unit after intervention | until discharge (approximately 10 days postoperative) | 
| Length of hospital stay | Number of days the patient has to stay in hospital | 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 | 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 | 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 | preoperative and 6 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elective surgery, minimally invasive surgery, cardiac valve reconstruction, cardiac valve replacement