Multicenter, Non-randomized Clinical Trial to Reinforce the Current Efficacy and Safety Clinical Data of the Dokimos Plus Aortic Valve
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Transvalvular gradient
研究概览
简要总结
This study intends to reinforce the current clinical information regarding safety and efficacy of the Dokimos Plus aortic valve prosthesis in patients in whom an aortic valve replacement with a bioprosthesis has been indicated.
详细描述
Multicenter, non-randomized, longitudinal case series clinical trial designed to reinforce the current safety and efficacy clinical data of the Dokimos Plus aortic valve and renew the CE mark.
The study foresees the inclusion of 80 patients recruited prospectively. Patients over 65 who have been diagnosed with a heart valve disease and who require surgical aortic valve replacement, or younger patients who are unsuitable for long-term anticoagulation due to medical contraindications or lifestyle considerations. The study will collect information on the Dokimos Plus aortic valve transvalvular gradient at 6 months and 12 months after the implantation. In addition, patients will be annually followed-up, up to 10 years after implantation.
The objective of the study valve is to improve life expectancy and quality of life of patients with a diseased aortic valve, replacing it with a bioprosthesis that can be safely implanted, with good hemodynamics and long durability.
Clinical studies carried out up to date have shown that the Dokimos Plus aortic valve presents satisfactory clinical and hemodynamic results, similar to those of other bioprothesis available on the market. In addition, the post-marketing surveillance carried out by the manufacturer has not revealed any relevant events regarding the Dokimos Plus aortic valve safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 over 18
- •Patients with the ability to understand the study requirements, be able to given written informed consent, and be willing and able to comply with the study requirements (including follow-up visits).
- •Patient candidates to an aortic bioprosthesis implantation according to the standard clinical practice guidelines.
- •Patients requiring isolated aortic valve replacement, or in combination with coronary artery bypass surgery and / or in combination with ascending aorta replacement surgery.
- •Women are eligible for the study if: a) are not pregnant or breastfeeding, b) are not of childbearing potential, c) if women of childbearing potential, a negative urine pregnancy test should be done within 48 hours before the intervention and must use an effective contraceptive method.
排除标准
- •Cardiac surgery contraindications.
- •Patients who require other interventions than the isolated aortic valve replacement or with coronary artery bypass surgery and / or in combination with ascending aorta replacement surgery as concomitant procedure.
- •Patients with LVEF < 30%.
- •Cardiac surgery reintervention.
- •Cardiogenic shock or hemodynamic instability within 24 hours prior to surgery.
- •Patient who are not willing to attend to the required follow-up visit.
- •Patients with active endocarditis (in the case of cured endocarditis, the presence of at least two negative blood cultures must be confirmed before their inclusion in the study).
- •Patient undergoing hemodialysis or with severe renal impairment (eGFR<30ml/min/1,7m2).
- •Pregnant women.
- •Patients with hyperparathyroidism.
- •Life expectancy less than 2 years.
- •Patients with a history or diagnosis of a medical problem or psychiatric illness or disorder that, according to the investigator evaluation, would make the patient not eligible to participate in the study.
结局指标
主要结局
Transvalvular gradient
时间窗: Up to 12 months
Dokimos Plus aortic valve transvalvular gradient at 6 months and at 12 months after the implantation.
次要结局
- Number of participants with abasence of valve deterioration(12 months)
- Number of participants with absence of endocarditis or thrombosis(10 years)
- Number of participants with absence of non-structural valve deterioration(12 months)
- Number of participants with need for prosthetic replacement(10 years)