Prospective Post-Market Clinical Follow-Up Registry to Assess the Long-term Safety and Effectiveness for the Treatment of Severe Symptomatic Aortic Valve Stenosis Using Valvosoft Non-Invasive Ultrasound Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Rate of MACE
研究概览
简要总结
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the Valvosoft® non-invasive ultrasound therapy (NIUT) device in patients with severe symptomatic calcific aortic stenosis (sSAS).
Valvosoft® delivers focused, high-intensity, short-duration ultrasound pulses to the aortic valve via a trans-thoracic approach, inducing non-thermal mechanical softening of calcified valve tissue.
This registry will enroll up to 200 participants across approximately 20 clinical sites in Europe following CE marking. Participants will be followed from discharge through 12 months post-procedure to assess clinical outcomes, quality of life, echocardiographic parameters, and safety events in a real-world setting.
详细描述
Severe symptomatic calcific aortic stenosis is associated with high morbidity and mortality, and some patients are not eligible for or decline standard valve replacement therapies (TAVR/SAVR).
Valvosoft® is an ultrasound image-guided, non-invasive therapy designed to mechanically soften calcified aortic valve leaflets using focused ultrasound energy without thermal damage.
The VALOR-PMCF registry is a prospective, multicenter study conducted to confirm the safety, clinical performance, and benefit-risk profile of Valvosoft® in real-world practice following CE marking.
Participants will be followed for up to 12 months to assess safety events, clinical status (NYHA), quality of life (KCCQ), and echocardiographic parameters, including aortic valve area and transvalvular gradients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Suffering from calcific sSAS according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease.
- •Not recommended by the local heart team for immediate TAVR/SAVR, or refusing such an intervention.
- •Willing to provide a written informed consent prior to participating in this Registry.
- •Able to comply with the follow up schedule or other Study requirements.
排除标准
- •Prosthetic aortic valve;
- •Chest deformity preventing optimal contact between Patient's chest and Valvosoft Applicator;
- •Thoracic injured skin, presence of scar(s) and/or burn(s) on thorax that may be in contact or close proximity with Valvosoft Applicator;
- •Pregnant or breastfeeding Patient.
研究组 & 干预措施
observational group
patients suffering from severe AS, not recommended for immediate AVR by local HEART Team or refusing an AVR and are treated with Valvosoft
干预措施: Valvosoft Treatment (Device)
结局指标
主要结局
Rate of MACE
时间窗: at 30 days post procedure
Rate of MACE defined as a composite endpoint including all-cause mortality, myocardial infarction, stroke, myocardial infarction and rehospitalization for heart failure, up to 30-days post procedure(s)
次要结局
未报告次要终点