NL-OMON52528已完成3 期
Rotterdam Edoxaban Leaflet Evaluation in Patients after Transcatheter Aortic Valve Implantation - REDOX TAVI
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients completed successful elective TAVI for severe aortic valve stenosis
- •with any commercially-available transcatheter heart valve (THV).
- •-Correct positioning of a single prosthetic heart valve into the proper
- •anatomical location
- •-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 VARC-3 consensus, No formal
- •indication for oral anticoagulation
- •- No cardiac structural complication defined by the VARC-3 consensus
- •- 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 >= BARC 3b definitions
- •within the last year
- •Other conditions with a high risk of bleeding
- •- Active peptic ulcer or upper gastrointestinal bleeding within last 3 months
- •prior to enrolment
- •- 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
- •- Atriovenous malformations with high risk of bleeding
- •- Vascular aneurysms
- •- Major intraspinal or intracerebral vascular abnormalities
- •Hypersensitivity or contraindications to edoxaban
- •Requirement for dual-antiplatelet therapy (DAPT) within 1 month prior to
- •Concomitant percutaneous coronary intervention (PCI) during the TAVI procedure,
- •requiring DAPT after the procedure.
- •Renal impairment defined as by dialysis-dependency or GFR < 30 mL/min at
- •time of enrollment
- •Active bleeding or bleeding diasthesis including thrombocytopenia (platelet
- •count < 50.000 cells/UL), thrombobasthenia, haemophilia or von Willebrand
- •Patients unable to adhere to or complete the investigational protocol for any
- •reason including but not limited to geographical residence, psychiatric
- •condtition or life-threatening disease
- •Pregnant or breast-feeding subjects
- •Current participation in clinical trials that potentially interfere with the
- •current study
研究者
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