Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- All-cause mortality
研究概览
简要总结
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).
详细描述
Aortic stenosis (AS) is a narrowing of the aortic valve opening causing restricted blood flow from the left ventricle to the aorta and may also affect the pressure in the left atrium. Aortic regurgitation (AR) is a condition where the aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of AS and AR may include fatigue and shortness of breath. Aortic valve disease can affect both elderly and younger populations. TAVIS Registry will collect data from patients suffering from either AS or AR using a minimally invasive transcatheter aortic valve implantation procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 who have signed ICF and are indicated by their doctors to be treated with Trilogy Heart Valve System in line with the medical standard of care
- •Patients with symptomatic severe aortic regurgitation (AR) or symptomatic, severe aortic stenosis (AS), who are at high risk for SAVR as documented by the heart team and Heart Team agrees that patient can undergo SAVR for "bail out"/to address unfavorable circumstances if necessary
- •Patients 18 years of age or older
- •Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the study
- •The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
排除标准
- •Patients who have known hypersensitivity or contraindication to Nitinol (titanium and/or nickel), an anti-coagulation/anti-platelet regimen or contrast medium that cannot be managed with premedication
- •Patients who have active bacterial endocarditis or other active infections
- •Pediatric (<18 years) and/or pregnant/nursing patients
- •Congenital/functional unicuspid, bicuspid or quadricuspid native aortic valve morphology
- •Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
- •Echocardiographic evidence of current left heart thrombus
- •Hypertrophic cardiomyopathy with or without obstruction.
- •Access vessel characteristics that would preclude safe placement of the JenaValve 20Fr introducer sheath, such as severe obstructive calcification, severe tortuosity, or vessel diameter <7mm.
研究组 & 干预措施
Trilogy TAVI
Patients receiving JenaValve Trilogy Heart Valve System for management of symptomatic, severe aortic stenosis (AS)/ aortic regurgitation (AR) who are at high risk for surgical aortic valve replacement (SAVR)
干预措施: Transcatheter Aortic Valve Implantation (TAVI) (Device)
结局指标
主要结局
All-cause mortality
时间窗: 30-days post-index procedure
Mortality from any cause in patients receiving TAVI for AR or AS
次要结局
- Acute kidney injury stage 2-3(7 days)
- Major vascular complications(30 days)
- Stroke(30 days and 1 year)
- Death(1 year)
- New conduction defects requiring permanent pacemaker(30 days)
- Major and life-threatening bleeding(30 days)
- New onset atrial fibrillation(30 days)