NCT03613246进行中（未招募）不适用
Clinical Outcomes of the NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population With Elevated Surgical Risk
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- NVT GmbH
- 入组人数
- 346
- 试验地点
- 14
- 主要终点
- Cardiovascular death
研究概览
简要总结
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Symptomatic degeneration of severe calcified aortic heart valve OR failing surgical aortic bioprosthetic valve
- •Acceptable candidate for elective treatment with the ALLEGRA TAVI System TF (according to the most recent version of the ALLEGRA Instructions For Use)
- •High risk for surgery as assessed by the heart team
- •Has signed the Patient Informed Consent Form >= 18 years
排除标准
- •Echocardiographic evidence of intracardiac 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 ventricular dysfunction with LVEF <20%
- •Evidence of active endocarditis or other acute infections
- •Renal failure requiring continuous renal replacement therapy
- •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
- •Life expectancy ≤ 12 months due to other medical illness
- •Currently participating in another investigational drug or device study
- •Patients with native aortic valve disease:
- •Unicuspid or bicuspid aortic valve
- •Non-calcified aortic stenosis
- •Combined aortic valve disease with predominant aortic regurgitation > 3
- •Distance between aortic valve basal plane and the orifice of the lowest coronary artery < 8 mm
- •Patients with degenerated surgical bioprosthetic aortic valves:
- •Low position of the coronary ostia, especially in combination with shallow sinuses
- •Internal diameter of the bioprosthesis is ≤16 mm or >28 mm
- •Partially detached leaflets that in the aortic position may obstruct a coronary ostium
结局指标
主要结局
Cardiovascular death
时间窗: 30 days post-index procedure
次要结局
- All-cause mortality(up to five years)
- Technical success of implantation(day of procedure)
- Assesment of NYHA classification(30 days, 12 month, 24 month, 36 month, 48 month, 60 month)
- Safety profile according to VARC II(30 days)
- In-hospital mortality(date of procedure till date of estimated discharge, assessed up to two weeks)
- Quality of life (EQ5D 5L)(30 days, 12 month, 24 month, 36 month, 48 month, 60 month)
- New pacemaker implantation(up to five years)
- assessment of mean aortic gradient post-implantation(up to five years)
研究者
研究点 (14)
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