NCT02209298已完成不适用
Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study.
Medtronic Bakken Research Center25 个研究点 分布在 4 个国家目标入组 202 人开始时间: 2014年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 25
- 主要终点
- Lack of significant aortic stenosis or insufficiency
研究概览
简要总结
This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).
详细描述
To collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for TAVI in patients with failing surgical aortic bioprosthesis who are at high risk for redo surgery.
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
- •Patient is > 18 years old
- •Patient has a symptomatic degeneration of aortic bioprosthesis
- •Acceptable candidate for elective treatment with the Medtronic CoreValveTM System (according to the most recent version of the Medtronic CoreValveTM Instructions For Use) and in conformity with the local regulatory and reimbursement context
- •Logistical Euroscore > 20% or STS > 10% or presence of comorbidities responsible of contra-indication(s) for redo surgery as assessed by at least one cardiac surgeon or patients in whom heart team has assessed the redo surgery at high risk
- •The patient or legal representative has been informed of the nature of the procedure and the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")
- •The patient is willing and able to comply with requirements of the study, including the 24 months follow-up
- •Patient will receive the CoreValveTM device in a degenerated surgical bioprosthesis
排除标准
- •Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
- •Patient in whom heart team considers that risk of TAVI is too high with a particular attention for the risk of coronary occlusion
- •Patient with prior endocarditis on failed bioprosthesis
- •Patient has other medical illness associated with a limited life expectancy (i.e., less than 1 year)
- •Patient with LVEF <20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices
- •Patient with severe mitral disease associated with severe pulmonary hypertension
- •Acute coronary syndrome less than 7 days before intervention
- •Currently participating in another investigational drug or device study.
- •Patient with significant paravalvular regurgitation
- •Patient in whom internal diameter prosthesis is equal to 17 mm
结局指标
主要结局
Lack of significant aortic stenosis or insufficiency
时间窗: 1 year Follow-up
Cardiovascular death
时间窗: 30 days post-index procedure
次要结局
- Safety composite endpoint based on VARC-II endpoint definitions(At 30 days and during follow-up visits)
- Peri-procedural myocardial infarction, major and minor access site complications, major bleeding, stroke, acute kidney injury stage III, new pacemaker implantation, and post-implantation aortic gradient(At 30 days and during follow-up visits)
研究者
研究点 (25)
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