Prospective Non-randomized Single Arm Multi-center Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65 (RESILIENCE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- Time to bioprosthetic valve failure due to valve deterioration
研究概览
简要总结
The objective of this observational trial is to determine time to valve failure due to valve deterioration requiring re-intervention and collect/investigate early potential predictors of valve durability (e.g., calcification and hemodynamic deterioration) in RESILIA tissue valves.
详细描述
Multicenter, prospective, non-randomized, single-arm, observational trial. Subjects will be evaluated at 5, 7, 9, and 11 years post-implant. Up to two hundred fifty (250) total subjects at up to fifteen (15) investigational sites will be enrolled.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Subject currently has an Edwards pericardial aortic bioprosthesis with RESILIA tissue
- •Provides voluntary written informed consent prior to the first trial related procedure
- •Subject agrees to attend follow-up assessments as specified in the protocol
排除标准
- •Age 65 years or older at time of aortic valve replacement
- •The Subject is pregnant or planning to become pregnant at the time of screening
- •Re-intervention required on the bioprosthetic aortic valve prior to screening
- •Active endocarditis or history of endocarditis on bioprosthetic aortic valve
- •Estimated life expectancy <24 months
- •Subjects with history of or current renal failure requiring dialysis
- •Altered mineral metabolism (hyperparathyroidism, parathyroid tumors)
- •Has prior organ transplant or is currently an organ transplant candidate
结局指标
主要结局
Time to bioprosthetic valve failure due to valve deterioration
时间窗: 11 years post-implant
Time to bioprosthetic valve failure due to valve deterioration is defined as subject requiring valve re-intervention (redo surgery, valve-in-valve) or confirmed study valve-related death.
次要结局
- Collection of early possible predictors of valve failure including leaflet calcification and morphological/hemodynamic valve deterioration(5, 7, 9, and 11 years post-implant)