NCT05478161已完成不适用
Investigation of the Safety and Performance of the NVT ALLEGRA THV System With a New Delivery System in Patients With Severe Calcified Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NVT GmbH
- 入组人数
- 137
- 试验地点
- 13
- 主要终点
- Device success at 7 days
研究概览
简要总结
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
The primary endpoint is device success rate at 7 days (discharge from index procedure or 7 days post implant, whichever comes first), as defined by VARC 2.
Based on the outcomes of a study with a similar device and considering a drop-out rate of 5%, 107 patients need to be enrolled in the study.
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
- •Symptomatic severe calcific stenosis of a native aortic valve with an AVA ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2), AND mean aortic pressure gradient ≥ 40mmHg OR maximal transaortic velocity ≥4.0m/s OR Doppler velocity index ≤0.25 on site-reported echocardiography OR symptomatic patients with degeneration of a surgical bioprosthetic valve (stenosis +/- insufficiency) on site-reported echocardiography
- •Local multi-disciplinary Heart Team and Central Screening Committee (CSC) agree on indication and eligibility for TAVI
- •Age ≥18 years
- •Patient has signed the Patient Informed Consent Form
- •Patient is willing and able to comply with requirements of the study, including all follow-up visits
排除标准
- •Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is <16.5 mm or >27 mm
- •Echocardiographic evidence of intracardiac thrombus or vegetation (site-reported)
- •Significant disease of the aorta that would preclude safe advancement of the ALLEGRA THV System
- •Severe ilio-femoral vessel disease that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access impossible
- •Porcelain aorta
- •Severe left ventricular dysfunction with ejection fraction (EF) <20% (site-reported)
- •Evidence of active endocarditis or other acute infections
- •Renal failure requiring continuous renal replacement therapy
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Any percutaneous interventional procedure (e.g. PCI with stenting) within 14 days prior of the index procedure
- •Acute MI ≤30 days prior to the index procedure
- •Symptomatic carotid or vertebral artery disease requiring intervention or carotid/vertebral intervention within the preceding 45 days
- •Cerebrovascular accident (CVA) or transient ischemic attack (TIA) ≤6 months or prior CVA with moderate or severe disability (e.g. modified Rankin scale score >2)
- •History of bleeding diathesis or coagulopathy; acute blood dyscrasias as defined: thrombocytopenia (platelets <80,000/µl), acute anemia (hemoglobin <10 g/dl), leukopenia (WBC <3000/ µl)
- •Active peptic ulcer or gastrointestinal (GI) bleeding ≤3 months
- •Severe (greater than 3+) mitral insufficiency (site-reported)
- •Uncontrolled atrial fibrillation
- •Required emergency surgery for any reason
- •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
- •Pregnancy or intend to become pregnant during study participation
- •Specific exclusions in patients with native aortic valve disease (site-reported):
- •Unicuspid or bicuspid aortic valve
- •Non-calcified aortic stenosis
- •Predominant aortic regurgitation > grade 3
- •Distance between native aortic valve basal plane and the orifice of the lowest coronary artery <8 mm
- •Specific exclusions in patients with degenerated surgical bioprosthetic aortic valves (valve-in-valve) (site-reported):
- •Low position of the coronary ostia, especially in combination with shallow sinuses (high risk of coronary occlusion)
- •Partially detached leaflets that may obstruct a coronary ostium
研究组 & 干预措施
treatment
Experimental
TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
干预措施: (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis (Device)
结局指标
主要结局
Device success at 7 days
时间窗: 7 day
* Absence of procedural mortality AND * Correct positioning of a single device in the proper anatomical location (site-reported) AND * Intended performance of the prosthetic heart valve (as determined by an independent Echo Core Lab at discharge from index procedure or 7 days post implant, whichever comes first) * Indexed Effective Orifice Area (iEOA) \> 0.85 cm2/m2 for BMI \< 30kg/m2 and iEOA \> 0.70 cm2/m2 for BMI ≥ 30kg/m2 * Mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s * No moderate or severe prosthetic valve regurgitation
次要结局
- All stroke(up to 12 months)
- TIA(up to 12 months)
- Transvalvular mean and peak pressure gradient as assessed by transthoracic echocardiogram (TTE)(up to 12 months)
- NYHA classification(30 days, 6 months, and 12 months)
- All-cause mortality(up to 12 months)
- Effective orifice area (EOA) as assessed by transthoracic echocardiogram (TTE)(up to 12 months)
- Trans- and paravalvular regurgitation as assessed by transthoracic echocardiogram (TTE)(up to 12 months)
- Early safety(up to 30 days)
- Quality of life as assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)(up to 12 months)
- Cardiovascular mortality(up to 12 months)
- Procedural success(assessed immediately after the procedure)
- Time-related valve safety(up to 12 months)
- New pacemaker implantation(up to 12 months)
- Delivery system related AEs(discharge from index procedure or 7 days post implant, whichever comes first)
研究者
研究点 (13)
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