PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,043
- 试验地点
- 27
- 主要终点
- Time to all-cause death
研究概览
简要总结
Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world. Per year, about 1.8-1.9% of these patients develop aortic valve stenosis which will eventually be treated by TAVI (Transcatheter aortic valve implantation).
The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, hereafter referred to as the ACURATE neo2™ and transfemoral delivery system in the context of an observational investigator initiated trial (IIT).
详细描述
There are four leading causes of valvular aortic valve stenosis, namely: calcific aortic stenosis, congenital aortic valve malformations, rheumatic aortic valve stenosis, and endocarditis. Calcific aortic valve stenosis is a chronic progressive disease, and the predominant cause of aortic valve stenosis in the Western world. Multiple mechanisms influencing the progression of aortic valve stenosis have been identified. However, there is still no sufficient drug therapy to stop or reverse the process.
If high-grade aortic valve stenosis becomes symptomatic, death rates increase up to 50% in 2 years.Many patients with severe and symptomatic aortic stenosis are successfully treated with surgical aortic valve replacement (SAVR), which can reduce symptoms and improve survival. However, up to one-third of symptomatic patients are considered inoperable due to comorbidities and the high risk of surgery. This treatment gap forced the development of less invasive approaches for patients with aortic stenosis considered inoperable and led to the development of TAVI. Later, TAVI has also been considered in the European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2017 and American Heart Association/American College of Cardiology (AHA/ACC) guidelines for the management of patients with valvular heart disease and intermediate surgical risk and recently, new landmark studies have expanded the use of TAVI into the low surgical risk field.
For the establishment of TAVI as the first line treatment option in lower risk patients, further improvement with regard to adverse outcomes associated with TAVI (e.g. vascular complications, rates of paravalvular leak/aortic regurgitation and the need for permanent pacemakers) will be essential. Therefore, large registries are needed to detect rare events and tendencies in a real-world setting.
The PROVE study will collect baseline, procedural and follow-up data. In addition, it will serve as an imaging library (angiography, echocardiography and cardiac computed tomography) to evaluate the potential advantages and disadvantages of the ACURATE neo2.
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
- •Planned transcatheter treatment of severe aortic stenosis with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.
- •Age ≥ 18 years of age
- •Written informed consent by patient and/or legal representative
排除标准
- •Patient is unlikely to be able or willing to follow the investigator's instructions during study participation.
- •Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
- •Patients placed in an institution by official or court order
结局指标
主要结局
Time to all-cause death
时间窗: through study completion, an average of 1 year
The individual survival time is calculated from the day of procedure up to death of any cause or up to the last last date on which the patient was known to be alive.
次要结局
- Neurological events (count)(through study completion, an average of 1 year)
- Bleeding events (rate)(through study completion, an average of 1 year)
- Cardiac structural complications (count)(through study completion, an average of 1 year)
- Bioprosthetic valve dysfunction (count)(through study completion, an average of 1 year)
- Mortality (count)(through study completion, an average of 1 year)
- Myocardial infarction (count)(through study completion, an average of 1 year)
- Vascular and access-related complications (count)(through study completion, an average of 1 year)
- Mortality (rate)(through study completion, an average of 1 year)
- Re-hospitalization (count)(through study completion, an average of 1 year)
- Re-hospitalization (cumulative incidence)(through study completion, an average of 1 year)
- Transfusions(through study completion, an average of 1 year)
- Conduction disturbances and arrhythmia (rate)(through study completion, an average of 1 year)
- Acute kidney injury (count)(through study completion, an average of 1 year)
- Neurological events (rate)(through study completion, an average of 1 year)
- Myocardial infarction (rate)(through study completion, an average of 1 year)
- Bleeding events (count)(through study completion, an average of 1 year)
- Cardiac structural complications (rate)(through study completion, an average of 1 year)
- Other acute procedural and technical valve related complications (count)(through study completion, an average of 1 year)
- Other acute procedural and technical valve related complications (rate)(through study completion, an average of 1 year)
- Conduction disturbances and arrhythmia (count)(through study completion, an average of 1 year)
- Vascular and access-related complications (rate)(through study completion, an average of 1 year)
- Acute kidney injury (rate)(through study completion, an average of 1 year)
- Bioprosthetic valve dysfunction (rate)(through study completion, an average of 1 year)
- Clinically significant valve thrombosis (rate)(through study completion, an average of 1 year)
- Patient-reported outcomes and health status(through study completion, an average of 1 year)
- Clinically significant valve thrombosis (count)(through study completion, an average of 1 year)
研究者
Holger Thiele
Prof. Dr.
University of Leipzig