Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PremiCron® | Assessment of PremiCron suture for cardiac valve reconstruction and replacement |
Not provided
| 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
| from intervention up to 6 months postoperative |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
adult patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ulrich FW Franke, Prof. Dr. med. | Robert Bosch KrankenhausDepartment for Thoracic and Vascular Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Bosch KH Stuttgart | Stuttgart | 70376 | Germany | |||
| Hospital de la Santa Creu I Sant Pau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37113912 | Result | Rufa M, Ursulescu A, Baumann P, Ferrer MT. A prospective, international, bicentric study to evaluate PremiCron suture material for cardiac valve surgery - PREMIVALVE a cohort study. Ann Med Surg (Lond). 2023 Apr 4;85(4):835-841. doi: 10.1097/MS9.0000000000000442. eCollection 2023 Apr. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Barcelona |
| 08026 |
| Spain |
| D014694 |
| Ventricular Outflow Obstruction |