BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Valve performance
研究概览
简要总结
Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.
详细描述
Study Design Study Design: prospective non-interventional multicenter registry Screening: MSCT submitted to core lab & sizing strategy pre-declared (annular sizing, supra-annular sizing, mix of both methods) Follow up: MSCT and TTE to cooper lab
TAVI treatment Predilatation according to aortic annulus Dmin Evolut Pro (23-26-29) and Evolut R 34 XL Annular anchoring of the THV Postdilatation according to the operators' discretion Study Population All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Inclusion Criteria 1. Age ≥18 years. 2. NYHA≥2 and/or syncope and/or angina. 3. Patient judged by the Heart Team as indicated for TAVI. 4. Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.
5. Estimated life-expectancy>1 year.
Exclusion Criteria 1. Age <18 years 2. Asymptomatic patients 3. Estimated life expectancy<1 year 4. Pure aortic regurgitation. 5. LVEF<20% 6. No baseline MSCT evaluation. 7. Unsuitable aortic root anatomy for Evolut Pro or XL. 8. Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL. Primary Endpoint Valve performane Secondary endpoints 30 day and 1 year mortality Patient-prosthesis mismatch Ellipticity index at 30 days Follow-up 30 days: physical examination, ECG, TTE /MSCT upon operators' judgement
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.
- •Patient judged by the Heart Team as indicated for TAVI.
- •Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, 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.
- •No baseline MSCT evaluation.
- •Unsuitable aortic root anatomy for Evolut Pro or XL.
- •Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL.
结局指标
主要结局
Valve performance
时间窗: one year
effective orifice area\<0.85 cm2/m2 and/or mean gradient\>20 mmHg and/or aortic regurgitation\>moderate
次要结局
- mortality(30 days and one year)
- Patient-prosthesis mismatch(30 days and 1 year)
- Ellipticity index at 30 days(30 days)
研究者
Didier TCHETCHE
Head of structural heart disease program
Clinique Pasteur