Enable I Long-term Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Assess the Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis
研究概览
简要总结
This was a prospective, non-randomized, multi-center, non-interventional post-market study. The study was a post-market long-term follow-up study based on the same cohort of patients (148 patients) enrolled in a previous investigational study from March 2007 to December 2009 (ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005) involving 10 European sites. Patient follow-up took place on a yearly basis up to 10 years after the implant/enrollment. The primary objective of this study was to evaluate the safety and effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis during long-term follow-up.
As this was an observational study, safety and efficacy data were summarized and described. There was no statistically powered study hypothesis.
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 who were enrolled and implanted for the ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005
- •Patient willing to sign the new Data Release form (DRF) or Patient Informed Consent (PIC) for the post-market study (what is applicable for the study due to local requirements and regulations)
排除标准
- •ATS 3f Enable™ Aortic Bioprosthesis Model 6000 was explanted
- •Patient died
- •Patient lost to follow-up
- •Patient withdrew consent
结局指标
主要结局
Assess the Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis
时间窗: 10 Years Post-Procedure
Long-term safety will be assessed by collecting following reported adverse events addressed: Migration, Valve Related Thromboembolism, Valvular thrombosis, Haemorrhage, Perivalvular Leak, Endocarditis, Hmolysis, Structural valve Deterioration, Non-Structural Dysfunction, Reoperation, Explant and Death.
Assess the Long-term Clinical Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: NYHA Functional Classification
时间窗: 10 Years Post-Procedure
Long-term clinical effectiveness of the Aortic Bioprosthesis will be assessed by collecting the NYHA-class of enrolled subjects over a period of time, following surgery.
Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: Hemodynamic Performance
时间窗: 10 Years Post-Procedure
Hemodynamic performance of the Aortic Bioprosthesis will be assessed by specific echocardiography measurements
次要结局
未报告次要终点