Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Indeed, mortality increases once symptoms appears.
For several decades, surgical aortic valve replacement (SAVR) has been the standard of care for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to a paradigm shift in the treatment of severe AS, representing a less invasive alternative to surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly available evidence has led to an expansion of guideline recommendations for TAVI. Furthermore, newer generations of transcatheter heart valve (THV) design, better patient selection, and technical enhancements have driven improvement in safety and reduction of procedural complications over time.
This observational study aim to prospectively evaluate the safety and efficacy of the procedure and clinical outcomes in patients undergoing TAVI.
详细描述
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Indeed, mortality increases once symptoms appears.
For several decades, surgical aortic valve replacement (SAVR) has been the standard of care for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to a paradigm shift in the treatment of severe AS, representing a less invasive alternative to surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly available evidence has led to an expansion of guideline recommendations for TAVI.
This observational study aim to prospectively evaluate the safety and efficacy of the procedure and clinical outcomes in patients undergoing TAVI.
EffectTAVI is an observational, monocentric registry promoted by Department of Advanced Biomedical Sciences of University of Naples Federico II.
The aim is to collect clinical, procedural, echocardiographic data and to evaluate the clinical outcomes of TAVI procedure.
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
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic severe AS or degenerated bioprosthetic aortic valve and suitable for TAVI according to Heart Team evaluation;
- •Ability to provide informed consent.
排除标准
- •Contraindications to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis;
- •Poor adherence to scheduled follow-up;
- •Unable to understand and follow study-related instructions.
结局指标
主要结局
All cause mortality
时间窗: 1 year
All cause mortality
次要结局
- Number of participants with leaflet thickening(1 year)
- Cardiovascular mortality(1 year)
- Vascular and access-related complications(1 year)
- Number of participants with myocardial infarction(1 year)
- Cardiac structural complications(1 year)
- Number of participants with leaflet reduced motion(1 year)
- Number of participants with bleeding events(1 year)
- Number of participants with acute kidney injury(1 year)
- Hospitalization or re-hospitalization(1 year)
- Number of participants with neurological events(1 year)
- Number of participants with new conduction disturbances and arrhythmias(1 year)
- Number of participants with bioprosthetic valve dysfunction(1 year)
- Number of participants with clinically significant valve thrombosis(1 year)
研究者
Giovanni Esposito
Professor
Federico II University