Title Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Transvalvular gradient
研究概览
简要总结
The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity burden. The SAPIEN 3 Ultra RESILIA valve represents the last generation of the SAPIEN valve system and includes several important iterations (newer leaflet calcium-blocking technology targeting calcium-attracting free aldehydes, dry tissue storage, newer skirt textile design) that should translate into a favorable impact on valve durability at mid- to long- term follow-up
详细描述
Prospective observational registry including patients with severe aortic stenosis undergoing TAVR with the SAPIEN 3 Ultra RESILIA valve. All patients who will survive the procedure will undergo a clinical and echocardiographic follow-up at 1-3 months (± 15 days), at 1-year (±30 days), 3-5 year (±30 days), 6-8 year (±30 days) and 9-10 year (±30 days) after valve implantation. Transthoracic echocardiography (TTE) exams (baseline, 1-3-month, 1 year, 3-5 years, 6-8 years, and 9-10 years post-procedure) will be evaluated in a Centralized Echocardiographic Core Lab at the Quebec Heart and Lung Institute. The measurements obtained in the Core Lab regarding transvalvular gradient, EOA, PPM and PVL at 1-3 months will determine the primary outcome of the study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria - Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.
- •Successful valve implantation of the SAPIEN 3 Ultra RESILIA valve.
- •VARC-3- defined technical success defined as:
- •Freedom from mortality
- •Successful access, delivery of the device, and retrieval of the delivery system
- •Correct positioning of a single prosthetic heart valve into the proper anatomical location
- •Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access related, or cardiac structural complication - Absence of severe procedural or in-hospital complications (VARC-3 definitions): mortality, stroke, bleeding type 2-4, myocardial infarction, need for a second valve, valve embolization, coronary obstruction, annular rupture.
排除标准
- •Age >80 years
- •Severe pulmonary disease (FEV1 <50% predicted or need for home oxygen)
- •Severe renal dysfunction (eGFR <30 ml/min/1.73m2)
- •Frailty (Clinical Frailty Scale > 4)
- •Severe coronary disease (SYNTAX score >32)
- •Left ventricular ejection fraction ≤30%
- •Moderate-to-severe mitral regurgitation
- •Severe tricuspid regurgitation
- •Pulmonary systolic pressure >60 mmHg
- •STS-PROM >5%
- •Any disease leading to a life expectancy <5 years
结局指标
主要结局
Transvalvular gradient
时间窗: 1-3 months
Residual (peak and mean) transvalvular gradient
Paravalvular leaks
时间窗: 1-3 months
Paravalvular leaks evaluated by echocardiography imaging
Effective orifice area (EOA)
时间窗: 1-3 months
EOA evaluated by echocardiography imaging
Prosthesis-patient mismatch
时间窗: 1-3 months
Moderate or severe prothesis-patient mismatch (defines as an index aortic valve area 0.85-0.66 cm2/m2 (moderate), ≤0.65 cm2/m2 (severe) for patient with BMI ˂30km/m2 and 0.70-0.56 cm2/m2 (moderate), ≤0.55 cm2/m2 (severe) for patient with BMI ≥30km/m2 and/or moderate-severe aortic regurgitation (AR) (VARC-3 definition).
次要结局
- Bioprosthetic valve dysfunction(yearly)
- Bioprosthetic valve failure(1-, 3-5-, 6-8-, and 9-10-year follow-up.)
- Transvalvular gradient(1-, 3-5-, 6-8-, and 9-10-year follow-up.)
- Clinical events(1month and yearly up to 10-year)
- Valve thrombosis(1-3 months and yearly up to 10-year)
- Effective orifice area (EOA)(1-, 3-5-, 6-8-, and 9-10-year follow-up.)
- Paravalvular leaks(1-, 3-5-, 6-8-, and 9-10-year follow-up.)
- Valve endocarditis(1-3 months and yearly up to 10-year)
- Bioprosthetic valve dysfunction(1-, 3-5-, 6-8-, and 9-10-year follow-up.)
- Bioprosthetic valve failure(yearly)
研究者
Josep Rodes-Cabau
Principal Investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval