Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 22
- 主要终点
- Reduction in Leaflet Motion
研究概览
简要总结
This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.
详细描述
This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant, on patients that are off anticoagulation for at least 30 days. A minimum of 75 subjects with evaluable 4D CT scans will be enrolled at approximately 11 investigational sites where the devices are commercially available. For asymptomatic subjects, PIs and subjects will be blinded from the CT imaging results and from the Core Lab findings.
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
- •The subject has been successfully implanted with a commercially approved LivaNova bioprosthetic valve according to the instructions for use (IFU)
- •The subject has signed the informed consent.
- •The subject is at least 18 years of age at the time of implant and consent signature
- •The subject will be available for post-operative follow-up through one year
排除标准
- •The subject has a planned concomitant cardiac procedure other than coronary artery bypass graft (CABG) and septal myectomy, including MAZE procedures, atrial fibrillation surgery, and left atrial appendage exclusion or resection, or has a prosthetic heart valve or annuloplasty ring in any position
- •The subject has any medical condition requiring long term (> 6 months) anticoagulation or dual antiplatelet therapy
- •The subject has any clinical condition precluding the use of CT imaging with contrast
- •The subject had a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days of the planned valve implant surgery
- •The subject has active endocarditis, myocarditis, or sepsis
- •The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support
- •The subject is already included in another clinical trial that could confound the results of this clinical investigation
研究组 & 干预措施
Aortic Valve
LivaNova bioprosthetic aortic heart valve replacement
干预措施: 4D Cardiac CT Scan (Diagnostic Test)
Aortic Valve
LivaNova bioprosthetic aortic heart valve replacement
干预措施: LivaNova Bioprothetic Aortic Valve Implant (Device)
结局指标
主要结局
Reduction in Leaflet Motion
时间窗: 1 year post-implant
Report the overall incidence of reduced leaflet motion identified by CT imaging in commercially approved LivaNova bioprosthetic aortic heart valves up to 1 year post implant on patients that are off anticoagulation for at least 30 days. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (\<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (\>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion).
次要结局
- Reduced Leaflet Motion Through 4D Volume-rendered CT Scan(up to 1 year post-implant)
- Freedom From Valve Re-intervention(up to 1 year post-implant)
- Freedom From Valve Thrombosis(up to 1 year post-implant)
- New York Heart Association (NYHA) Assessment(1 year post-implant)
- Aortic Mean Gradient Through Transthoracic Echocardiogram (TTE)(up to 1 year post-implant)
- Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)(up to 1 year post-implant)
- Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes(up to 1 year post-implant)
- Reduction in Leaflet Motion by Relationship to Devices or Procedure(up to 1 year post-implant)
- Freedom From All-cause Mortality(up to 1 year post-implant)
- Freedom From Myocardial Infarction(up to 1 year post-implant)
- Freedom From Moderate or Severe Valve Regurgitation(up to 1 year post-implant)
- Effective Orifice Area Through Transthoracic Echocardiogram (TTE)(up to 1 year post-implant)
- Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)(up to 1 year post-implant)
- Freedom From Structural Valve Deterioration(up to 1 year post-implant)
- Freedom From Valve Endocarditis(up to 1 year post-implant)
- Freedom From Thromboembolic Events(up to 1 year post-implant)
- Freedom From Hemolysis(up to 1 year post-implant)
- Freedom From Major Bleeding(up to 1 year post-implant)
- Aortic Peak Gradient Through Transthoracic Echocardiogram (TTE)(up to 1 year post-implant)
- Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)(up to 1 year post-implant)