Trifecta™ Durability Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,151
- 试验地点
- 1
- 主要终点
- Actuarial Freedom From Reintervention Due to Structural Valve Deterioration
研究概览
简要总结
The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve. The Trifecta™ valve is a stented surgical aortic bioprosthesis with bovine pericardial leaflets designed for supra annular placement.
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
- •Patients implanted for less than 9 months with a Trifecta™ valve, or patients who are candidates for implant with a Trifecta™ valve, as per current guidelines
- •Patient requires aortic valve replacement.
- •Patient is legal age in host country.
- •Patients must be able and willing to provide written informed consent to participate in this investigation
- •Patients must be willing and able to comply with all follow-up requirements
排除标准
- •Patients with contraindication for cardiac surgery
- •Patients who are pregnant.
- •Patient is unwilling to or has an inability that reduces his mobility in order to attend the required follow-up visits.
- •Patient has active endocarditis
- •Patient has had an acute preoperative neurological event defined as patient has not returned to baseline 30 days prior to the planned valve implantation surgery.
- •Patient is undergoing renal dialysis.
- •Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate.
- •Patient has a documented thrombus in left atrium or left ventricle.
- •Patient had in the past mitral or tricuspid valve replacement.
- •Patient needs mitral and/or tricuspid valve replacement.
- •Patient has an Ejection Fraction < 25%
- •Patient had the Trifecta™ valve implanted as part of this study, but then had the device explanted
- •Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
- •Patient has a life expectancy less than two years.
结局指标
主要结局
Actuarial Freedom From Reintervention Due to Structural Valve Deterioration
时间窗: 10 years
Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve intervention for treatment of structural deterioration of the Trifecta™ valve through 10 years post-implant. This percentage is estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation.
次要结局
- Actuarial Freedom From All-cause Mortality(10 years)
- Freedom From Structural Valve Deterioration(10 years)
- Freedom From Valve Related Mortality(10 years)