NCT03287856已完成不适用
Investigation of the Safety and Performance of the NVT ALLEGRA TAVI System TF in Patients With Failed Surgical Aortic Bioprosthesis and Elevated Surgical Risk
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NVT GmbH
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Mean pressure gradient
研究概览
简要总结
The study investigates the technical feasibility of the replacement of failed surgical bioprosthetic aortic valves by the ALLEGRA Transcatheter Heart Valve (THV) and describes the safety and performance profile
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •≥18 years
- •Symptomatic degeneration of aortic bioprosthesis showing echocardiographically mean aortic gradient >40mmHg or peak jet velocity >4.0m/s and AVA<1.0cm2 OR symptomatic patients with severe bioprosthetic valve insufficiency.
- •High risk for redo surgery defined by STS ≥10% / EuroScore II ≥7% OR as assessed by the heart team
- •Has signed the Patient Informed Consent Form
- •Willing and able to comply with requirements of the study, including all follow-up visits
- •Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
排除标准
- •Low position of the coronary ostia, especially in combination with shallow sinuses
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- •Significant aortic disease such as severe obstructive calcification or marked tortuosity or kinking which will preclude a safe advancement of the ALLEGRA TAVI System TF
- •Iliofemoral vessel conditions such as severe obstructive calcification, severe tortuosity or kinking that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access to the aortic valve impossible
- •Severe mitral insufficiency
- •Internal diameter of the bioprosthesis is ≤16 mm or >28 mm
- •Patient prosthesis mismatch (EOAi ≤0.65 cm2/m2) as the underlying cause of the poor valve function and need for re-intervention
- •Non-valvular stenosis as the underlying cause of the poor valve function and need for re-intervention
- •Failing pre-existing prosthetic heart valve or prosthetic ring in any other position than aortic
- •Partially detached leaflets that in the aortic position may obstruct a coronary ostium.
- •Existence of aortic conduit, aortic arch replacement, stentless bioprosthesis and autologous valve replacement
- •Paravalvular leak of the failing surgical bioprosthesis (between failing surgical bioprosthesis and native annulus)
- •LVEF <20%
- •Evidence of active endocarditis or other acute infections
- •End stage renal disease requiring chronic dialysis or creatinine clearance <20 ml/min or serum creatinine >3.0 mg/dl (264 µmol/l)
- •Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to Nitinol alloy or to bovine tissue
- •Evidence of an acute myocardial infarction within the past 30 days
- •Cerebral vascular accident (TIA, Stroke) within past 6 months (≤180 days)
- •Evidence of active peptic ulcer or upper gastrointestinal bleeding within past 90 days
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Hemodynamic instability (e.g. cardiogenic shock) requiring inotropic support or mechanical heart assistance (e.g. VAD, IABP)
- •Uncontrolled (therapy resistant) atrial fibrillation
- •Need for emergency surgery for any reason
- •Life expectancy ≤ 12 months due to other medical illness
- •Currently participating in another investigational drug or device study
结局指标
主要结局
Mean pressure gradient
时间窗: immediately after index-procedure
30-days survival
时间窗: 30 days
Proportion of participants with overall survival at 30 days
次要结局
- Early safety(30 days)
- Technical success of implantation(immediately after index-procedure)
- New Pacemaker implantation(up to 12 months)
- NYHA classification(up to 12 months)
- Cardiovascular mortality(30 days)
- Hemodynamic parameters(up to12 months)
- Time related valve safety(up to 12 months)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
不适用
Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance StudyPrimary OsteoarthritisSecondary OsteoarthritisPrimary Total Hip Replacement (THR)Avascular NecrosisNCT04425603Smith & Nephew Orthopaedics AG270
已完成
不适用
Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial FoldsNasolabial FoldsNCT05612958Dongkook Pharmaceutical Co., Ltd.82
尚未招募
不适用
Men and Women With Different Designs and Semi-individual Total Knee ReplacementArthroplasty, Replacement, KneeNCT04976400Peking University Third Hospital1,600
招募中
不适用
Clinical Performance of Dual-cantilevered Single-implant BridgeDental Implant FailedNCT06099717University of Bern50
招募中
不适用
Assessing the Usability and Reliability of the Prototype Prosthesis DevicesAmputationTraumatic AmputationsLeg AmputationNCT06616402Fondazione Don Carlo Gnocchi Onlus15