ACURATE neo2™ Post Market Clinical Follow up Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 19
- 主要终点
- Primary Safety Endpoint:
研究概览
简要总结
The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic stenosis.
详细描述
ACURATE neo2 PMCF is a prospective, open-label, single-arm, multicenter, observational post-market surveillance study. All subjects deemed treatable with the ACURATE neo2 valve will be approached to participate in the study.
A subject who provides an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC) and signed by the subject or the subject's legally authorized representative is considered enrolled once an attempt is made to insert the commercially available ACURATE neo2 Transfemoral Delivery System. Approximately 200 subjects will be enrolled.
Follow-up will occur at pre-discharge, 30 days, 1 year, and then annually from 2 through 5 years post index procedure per standard of care. Visits are in-person through 1 year and in-person (preferred) or via telephone interview in years 2 through 5. All subjects will undergo 4D computed tomography (CT) imaging at 30 days and 1 year.
ACURATE neo2 PMCF Study Design Overview Abbreviations: CT=computed tomography; ICF=Informed Consent Form
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
- •There are no specific inclusion criteria set for this post-market surveillance study. A subject must sign an IEC-approved ICF and the ACURATE neo2 Transfemoral Aortic Valve System should be used according to the commercial IFU.
排除标准
- •Subject has a previous bioprosthesis in the aortic position.
- •Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).
- •Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm.
- •Subject is expected to undergo chronic anticoagulation therapy after the TAVI procedure
- •Note : Subjects treated with short-term anticoagulation post-procedure can be included; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.
结局指标
主要结局
Primary Safety Endpoint:
时间窗: 30 days
All-cause mortality after the index implant procedure
Primary Imaging Endpoint:
时间窗: 30 days
Hypoattenuated leaflet thickening (HALT) as measured by 4D CT
次要结局
- Assessments using 4D CT-scan(30 days 1 year)
- Safety endpoints adjudicated by an independent Clinical Events Committee(all 5 years)
- Additional Safety Endpoints(all 5 years)
- EuroQoL Quality of Life questionnaire (EQ-5D-5L)(Baseline, 30-day, 1-year)
- Prosthetic Aortic Valve Performance as measured by transthoracic echocardiography (TTE)(Discharge, 30 days, annually from year 1 to 5)
- New York Heart Association (NYHA) functional classification(Baseline, Discharge, 30 days, annually from year 1 to 5)