SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Bioprosthetic Valve Failure
研究概览
简要总结
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
详细描述
Transcatheter aortic valve replacement (TAVI) has become the gold standard treatment for moderate-to-high risk elderly patients with severe symptomatic aortic stenosis. Based on the results of randomized trials including low risk patients, this treatment has been progressively applied to younger (in the sixties and seventies) patients with a low co-morbidity burden. Life expectancy in this group is expected to extend beyond 5 years from intervention in the vast majority of patients, and beyond 10 years in a high proportion. Thus, the issue of valve durability has become one of the most important aspects in the TAVI field in recent years. To date, the rates of bioprosthetic valve failure at 8-10 years after TAVI have been consistently <10%, but some studies have shown some degree of valve structural degeneration in close to one third of the patients at 8-year follow-up. This subclinical valve degeneration before the 10-year follow-up landmark would represent the initial step in the process of bioprosthetic valve failure, and further valve degeneration leading to clinical symptoms is likely to occur in a significant proportion of these cases.
This prospective registry will evaluate the clinical outcomes and the valve performance of the SAPIEN 3 Ultra RESILIA valve over 10 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adult patients (≥18 years)
- •Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve
- •Patient is willing to attend the follow-up visits up to 10 years at the center
排除标准
- •Lack of written informed consent
- •Emergency procedure
- •Pregnancy at time of TAVI
- •Critieria for long-term observation (1y-10y):
- •Technical success at exit from procedure room (VARC-3):
- •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 PTA and stenting without major bleeding) or to a major vascular or access related, or cardiac structural complication
- •Absence of the following severe procedural and in-hospital complications (VARC-3 definitions):
- •All stroke
- •Bleeding type 3-4
- •Myocardial infarction
- •Need for a second valve
- •Valve embolization
- •Coronary obstruction
- •Annular rupture
结局指标
主要结局
Bioprosthetic Valve Failure
时间窗: 3-5 years
Bioprosthetic valve failure (defined as valve-related mortality OR aortic valve re-operations/re-intervention OR stage 3 hemodynamic valve deterioration (VARC-3))
Early Safety
时间窗: 1-3 months
Early safety acc. to VARC-3
Device Success
时间窗: 1-3 months
Device Success acc. to VARC-3
Bioprosthetic Valve Failure
时间窗: 9-10 years
Bioprosthetic valve failure (defined as valve-related mortality OR aortic valve re-operation/re-intervention OR stage 3 hemodynamic valve deterioration (VARC-3))
Structural Valve Deterioration
时间窗: 9-10 years
Structural Valve Deterioration ≥ stage 2 (VARC-3)
次要结局
- Hemodynamic Valve Performance(All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year))
- Bioprosthetic Valve Failure(All follow-ups (1-3month, 1year, 3-5 year, 6-8year 9-10 year))
- Bioprosthetic Valve Dysfunction(All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year))
- Patient reported outcomes(1-3month, 1+3year Follow Up compared to BL)
- Cumulated incidence rate BVD or BVF(Up to 10 years)
- Clinical Events(All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year))
- Hemodynamic valve deterioration stage 2 and 3 (VARC-3)(All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year))