NCT06375590尚未招募不适用
NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 30-day device success (Rate)
研究概览
简要总结
The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring).
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
- •Age ≥ 18 years.
- •NYHA ≥ 2 and/or syncope and/or angina.
- •Symptomatic severe calcified aortic stenosis with AVA < 1 cm2 AND peak velocity > 4 m/s or mean gradient > 40 mmHg or DVI < 0.25'.
- •Patient judged by the Heart Team as indicated for TAVI.
- •Anatomical suitability for transfemoral-TAVI with Navitor, based on MSCT assessment.
- •Estimated life-expectancy > 1 year.
排除标准
- •Age < 18 years
- •Asymptomatic patients
- •Estimated life expectancy < 1 year
- •Pure aortic regurgitation.
- •LVEF < 20%
- •No baseline MSCT evaluation.
- •Unsuitable aortic root anatomy for Navitor.
- •Unsuitable peripheral vasculature for transfemoral Navitor.
- •Type 2 bicuspid aortic valve
- •Excessive leaflet calcifications
- •Moderate or severe raphe calcifications
- •Severe LVOT calcifications
- •Perimeter-derived annular dimension exceeding IFU recommendation
- •Dilated ascending aorta >45 mm
结局指标
主要结局
30-day device success (Rate)
时间窗: 30-day
as indicated in the VARC-3 criteria
次要结局
- 1 year at least moderate bioprosthetic valve deterioration(1-year)
- 30 days and 1 year all-cause and cardiovascular mortality(1-year)
- 30 days and 1 year stroke(1-year)
- 1 year severe patient-prosthesis mismatch(1-year)
研究者
Didier TCHETCHE
Head of structural heart disease program
Clinique Pasteur
研究点 (1)
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