Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of aortic valve leaflet thickening after TAVI as assessed by cardiac 4D computed tomography scan (4DCT)
研究概览
简要总结
A single-center, investigator-initiated, single arm interventional study in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the Erasmus Medical Center in Rotterdam (NL). Study population will be patients undergoing TAVR with no formal indication for oral anticoagulant (OAC) and no dual antiplatelet therapy (DAPT) requirement for coronary stents. Primary endpoint is the incidence of leaflet thickening on MSCT after three months of edoxaban treatment.
详细描述
Rationale: Thromboembolic- and bleeding events can occur after TAVI and can have great consequences. There is currently no evidence-based guideline on prevention of thromboembolic events after TAVI and the current standard of care with DAPT 3-6 months is based on expert opinion. Recently multislice computed tomography (MSCT) studies identified bioprosthesis leaflet thickening and impaired leaflet motion after TAVI. The goal of this study is to investigate whether in TAVI patients, treatment with edoxaban leads to a reduction in leaflet thickening incidence after 3 months and whether it is safe and clinically efficient.
Objective: To investigate whether treatment with edoxaban leads to a decrease in incidence of leaflet thickening and is clinical efficient and safe.
Study design: A single-center, investigator-initiated, open-label, observational study.
Study population: Patients undergoing transfemoral transcatheter aortic valve replacement in the Erasmus University Medical Center with no formal novel oral anticoagulants/vitamin-K-antagonist (NOAC/VKA) indication.
Intervention (if applicable): Patients will be treated with edoxaban for a period of 3 months following TAVI. Afterwards they will switch to acetylsalicylic acid.
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
- •Completed successful elective TAVI for severe native aortic valve stenosis with any commercially-available transcatheter heart valve (THV).
- •Correct positioning of a single prosthetic heart valve
- •Device success, defined by:
- •Mean aortic valve gradient < 20 mmHg
- •Peak transvalvular velocity < 3.0 m/s
- •Aortic valve regurgitation of 2 or less
- •No periprocedural complications.
- •No overt stroke
- •No uncontrolled bleeding
- •No major vascular complication defined by the Valve academic research committee 2 (VARC-2) consensus
- •No formal indication for oral anticoagulation
- •Prevention of thromboembolic complications in patients with atrial fibrillation
- •Prevention for recurrent venous thromboembolism
- •Prevention for recurrent pulmonary embolism
排除标准
- •History of life-threatening or major bleeding event ≥ Bleeding academic research committee (BARC) 3b definitions within the last year.
- •Conditions with a high risk of bleeding
- •Active peptic ulcer or upper gastrointestinal bleeding (< 3 months)
- •Malignancy with high risk of bleeding
- •Recent unresolved brain of spinal injury
- •Spinal or ophthalmic surgery within last 3 months prior to enrolment
- •Intracranial haemorrhage
- •Esophagal varices
- •Arteriovenous malformations with high risk of bleeding
- •Vascular aneurysms
- •Major intraspinal or intracerebral vascular abnormalities
- •Hypersensitivity or contraindications to edoxaban
- •No percutaneous coronary intervention within 6 months prior to randomization (requiring DAPT after TAVR)
- •Dialysis-dependency or glomerular filtration rate < 30 mL/min at time of enrollment
- •Active bleeding or bleeding diathesis including thrombocytopenia (platelet count < 50.000 cells/UL), thromboasthenia, haemophilia or von Willebrand disease
- •Patients unable to adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life-threatening disease
- •Pregnant or breast-feeding subjects
- •Current participation in clinical trials that potentially interfere with the current study
研究组 & 干预措施
Edoxaban
treatment with edoxaban
干预措施: Edoxaban (Drug)
结局指标
主要结局
Incidence of aortic valve leaflet thickening after TAVI as assessed by cardiac 4D computed tomography scan (4DCT)
时间窗: 3 months after TAVI
total of participants with aortic valve thickening after TAVI
次要结局
未报告次要终点
研究者
Nicolas van Mieghem
Principal investigator
Erasmus Medical Center