A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Presence of leaflet thrombosis
研究概览
简要总结
Aortic regurgitation (AR) is not uncommon. Transcatheter aortic valve implantation (TAVI) for treating pure aortic regurgitation is a potential future treatment option for pure AR especially in patients having high risk for open heart surgery.
TAVI using dedicated device for pure AR has a different anchor mechanism to TAVI for aortic stenosis (AS). AR patientsalso have different cardiac flow pattern, aortic root pathology and left ventricular remodeling pattern compared to AS patients. Subclinical leaflet thrombosis has been described in AS patient receiving TAVI, which will affect the durability and antithrombotic regime. Follow-up imaging for dedicated TAVI device in AR patient is limited.
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
- •receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH
- •with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy
- •Deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)
- •Capable of providing informed consent
排除标准
- •Evidence of intracardiac mass, thrombus or vegetation
- •Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
- •Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
- •Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
- •Chronic Kidney Disease with eGFR <30 ml/min/1.73m
- •Cardiogenic shock or other hemodynamic instability requiring inotropic support or ventricular assist device
- •Contraindicated for CT or MRI assessment
结局指标
主要结局
Presence of leaflet thrombosis
时间窗: 6 month
Presence of hypoattenuation affecting motion (HAM) detected on 6 month follow-up computed tomography
次要结局
- All-cause mortality(1-year)
- heart failure hospitalization(1-year)
- Magnetic Resonance Imaging (MRI)(1 month)
- Myocardial Infarction event(12 months post OP)
- New onset renal failure event(12 months post OP)
- Severe Bleeding event(12 months post OP)
- Non-elective aortic valve surgery event(12 months post OP)
- Non-elective transcatheter re-intervention event(12 months post OP)
- Major cardiac structural complications(12 months post OP)
- Major access site complications(12 months post OP)
- Computed Tomographic Endpoints(1-year)
- Echocardiographic Endpoints(12 months post OP)
- cardiovascular Mortality events(12 months post OP)
- Stroke event(12 months post OP)
- New pacemaker implantation event(12 months post OP)
- Acute Device Success Rate(immediately post-OP)
- Procedural Success Rate(immediately post-OP)
- NYHA Functional Class(12-month Post-OP)
研究者
Dr So Chak Yu kent
Clinical Assistant Professor
Prince of Wales Hospital, Shatin, Hong Kong