NCT03600662招募中不适用
TriRec - Trileaflet Reconstruction of the Aortic Valve
Deutsches Herzzentrum Muenchen2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2018年1月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Effective orifice area
研究概览
简要总结
Reconstruction of the aortic valve using the tri-leaflet repair technique is non-inferior with regard to effective orifice area (EOA) to surgical aortic valve replacement (SAVR) with a biological prosthesis (St. Jude Trifecta GT) as gold- standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 50 years
- •Documented symptomatic moderate or greater aortic stenosis or severe insufficiency
- •Aortic annulus > 19 mm
- •Written informed consent of the patient.
排除标准
- •Concomitant intervention of the aortic root
- •Concomitant intervention of the aortic arch
- •Concomitant valve surgery
- •Emergency surgery for any reason
- •Neurological events (i.e. stroke, TIA) within 6 months preoperatively
- •Coagulation disorders (including thrombocytopenia < 100.000/ml)
- •Porcelain aorta
- •Active endocarditis or other active systemic infections
- •Participating in another trial that may influence the outcome of this trial
- •Pregnancy
- •Dual antiplatelet therapy
- •Previous cardiac surgery (excluding percutaneous procedures)
研究组 & 干预措施
TriRec
Experimental
Trileaflet Reconstruction of the Aortic Valve
干预措施: TriRec (Other)
Aortic valve replacement
Experimental
Biological prosthesis, Device: St. Jude Medical Trifecta GT
干预措施: Aortic valve replacement (Other)
结局指标
主要结局
Effective orifice area
时间窗: 10th postoperative day +/- 4 days
Effective orifice area in cm2 (EOA) either after the TriRec- procedure or surgical valve replacement with the St. Jude Medical Trifecta GT Valve, measured by echocardiography
次要结局
- Effective orifice area(after 6 months, 1 year and thereafter annually until the 10th postoperative year)
- Maximum and mean aortic pressure gradients(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.)
- Estimation of aortic regurgitation, if applicable(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year)
- Left ventricular ejection fraction(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year)
- Left ventricular endsystolic and -diastolic diameter(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year)
- Left ventricular endsystolic and -diastolic volume(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year)
- Left atrial diameter(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year)
- Freedom from aortic valve reintervention at discharge(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year)
- Freedom from Mortality(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.)
- Freedom from Stroke(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.)
- Freedom from Myocardial infarction(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.)
- Freedom from conduction disturbances leading to permanent pacemaker implantation(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.)
- Freedom from Endocarditis(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.)
- Freedom from Bleeding requiring re-thoracotomy(10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
不适用
Image Fusion and Calcification Raising in Trans Aortic Valve ImplantationSymptomatic Aortic StenosisNCT03247465Nantes University Hospital
已完成
不适用
CardioCel Tri-leaflet Repair StudyAortic StenosisAortic InsufficiencyNCT02629328Anteris Technologies Ltd.28
已完成
不适用
Examination of aortic arch reconstruction method in the Norwood procedureHypoplastic left heart syndromeJPRN-UMIN000046796Osaka Women's and Children's Hospital Department of Cardiovascular Surgery31
已完成
Unknown
Tricuspid valve repair for tricuspid valve regurgitation in pediatric patients: Its mid-term results.tricuspid valve regurgitationJPRN-UMIN000049925Hyogo Prefectural Amagasaki General Medical Center31
招募中
3 期
A novel aortic valve reconstruction with autologous pericardium for aortic valve diseaseAortic valve stenosis and/or regurgitationJPRN-UMIN000011193Deparment of General and Cardiothoracic Surgery, Graduate School of Medicine, Gifu University10