Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation: a Real-world, Prospective, Multicenter Study (TRUST TAVR 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
- Combined clinical efficacy outcomes
研究概览
简要总结
The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected
详细描述
Pure native aortic valve regurgitation (NAVR) is a multifactorial valvular disease, with a prevalence of moderate or severe NAVR ranging from 0.5% to 2.7%. Patients with severe NAVR have a poor prognosis, conservative management has a 1-year mortality rate of more than 20%. Currently, surgical aortic valve replacement (SAVR) is the recommended treatment strategy for patients with NAVR. However, data showed that only 20% of patients with severe NAVR and left-ventricular ejection fraction (LVEF) of 30-50% undergo SAVR, while only 3% of those with an LVEF below 30% receive SAVR. Therefore, a less invasive surgical alternative therapy is needed for high surgical-risk patients from SAVR.
Transcatheter aortic valve replacement (TAVR) is now considered the first-choice treatment for elderly patients with aortic stenosis, regardless of surgical risk. Recently, it has also been used to treat patients with NAVR in an "off-label" setting. The latest European guidelines suggest that TAVR may be considered in experienced centers for selected patients with AR who are not eligible for SAVR. However, the role of TAVR in patients with severe NAVR is still debatable. Current studies on this topic are limited by their retrospective design and small sample sizes.
Dedicated devices for aortic regurgitation, such as the JenaValve, have shown promising results in terms of technical success and short-term outcomes. However, TAVR for patients with NAVR using on-label devices has a relatively high rate of pacemaker implantation. Additionally, the dedicated device was designed only for tricuspid valve anatomy, making TAVR with off-label devices the main invasive strategy for high-surgical risk patients with bicuspid valves. It's worth noting that the dedicated device is not yet commercially available worldwide. Therefore, further investigation into TAVR using off-label devices for NAVR patients, including those with bicuspid and tricuspid valves, is necessary.
The objective of this study was to evaluate the safety and efficacy of TAVR in patients with NAVR in a real-world setting.
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 diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.
- •Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form
排除标准
- •Patients who cannot provide informed consent
- •Patients who are treated with TAVR for aortic stenosis
- •Patients who are participating in other clinical trials
结局指标
主要结局
Combined clinical efficacy outcomes
时间窗: 1 year
Combined clinical efficacy outcomes as composed by all-cause mortality, all strokes, any hospitalization
次要结局
- Combined early safety and clinical efficacy outcomes(30 days)
- Rate of device success(discharge or 30 days)
- Valve-related long-term clinical efficacy(5 years and 10 years)
- Rate of technical success(at exit from procedure room)
- Rate of all-cause mortality(5years and 10years)
- Combined clinical efficacy outcomes(2 years, 3 years, 4 years)
研究者
LingTao
Professor in Cardiology, Director of the department of Cardiology
Xijing Hospital