NCT04096859已完成不适用
Assessment of PremiCron Suture for Cardiac Valve Reconstruction and Replacement. A Multi-centric, Prospective, Single Arm Observational Study in Daily Practice.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- a composite endpoint of Myocardial infarction, Stroke, Mortality until discharge and rate of Endocarditis of the replaced / reconstructed valve until 6 months
研究概览
简要总结
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
a composite endpoint of Myocardial infarction, Stroke, Mortality until discharge and rate of Endocarditis of the replaced / reconstructed valve until 6 months
时间窗: 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
次要结局
- Comparison of renal failure at different timepoints in postoperative course(until discharge (approximately 10 days postoperative), 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)
- Comparison of stroke at different timepoints in postoperative course(until discharge (approximately 10 days postoperative), 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)
- Comparison of atrial fibrillation valve at different timepoints in postoperative course(until discharge (approximately 10 days postoperative), 30 days and 6 months postop)
- Intraoperative handling of the suture material(intraoperative)
- Comparison of myocardial infarction (MI) at different timepoints in postoperative course(until discharge (approximately 10 days postoperative), 30 days and 6 months postop)
- Rate of adverse events(until 6 months postop)
- Employment status(preoperative and 6 months postoperative)
- 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)
- 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)
- Comparison of mediastinitis at different timepoints in postoperative course(until discharge (approximately 10 days postoperative), 30 days and 6 months postop)
- Length of hospital stay(until discharge (approximately 10 days postoperative))
- Course of Health Status(until 6 months postoperative)
- Comparison of bleeding at different timepoints in postoperative course(until discharge (approximately 10 days postoperative), 30 days and 6 months postop)
- Length of intensive care unit stay(until discharge (approximately 10 days postoperative))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Optilene® Suture for Coronary Artery Bypass Graft SurgeryMulti Vessel Coronary Artery DiseaseCoronary Heart DiseaseNCT02546557Aesculap AG245
Unknown
不适用
VIenna Pilot Study for Automated Annular Suturing TechnologyAortic Valve DiseaseMitral Valve DiseaseNCT04659655Medical University of Vienna30
终止
不适用
Perceval S Aortic Heart Valve Study- North AmericaAortic Valve StenosisAortic Valve Stenosis With InsufficiencyRegurgitation, Aortic ValveAortic Valve IncompetenceNCT01810679Sorin Group USA, Inc.355
已完成
不适用
The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE TrialChronic Heart FailureNCT01166347Medtronic Cardiac Rhythm and Heart Failure451
已完成
不适用
Vicryl Plus and Monocryl Plus in Breast SurgeryBreast Cancer SurgeryNCT00830271Cardiff and Vale University Health Board150