Rotterdam Edoxaban Leaflet Evaluation in Patients after Transcatheter Aortic Valve Implantation - REDOX-TAVI

Thoraxcentrum Erasmus MC0 个研究点目标入组 100 人开始时间: 2019年4月24日最近更新: 2024年4月8日

适应症

试验速览

暂无简介。

•Patients completed successful elective TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV).
•oCorrect positioning of a single prosthetic heart valve into the proper anatomical location
•oDevice 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
•oNo overt stroke
•oNo uncontrolled bleeding
•oNo major vascular complication defined by the VARC-3 consensus
•oNo cardiac structural complication defined by the VARC-3 consensus
•No formal indication for oral anticoagulation
•oPrevention of thromboembolic complications in patients with atrial fibrillation
•oPrevention for recurrent venous thromboembolism
•oPrevention for recurrent pulmonary embolism
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•History of life-threatening or major bleeding event = BARC 3b definitions within the last year
•Other conditions with a high risk of bleeding
•oActive peptic ulcer or upper gastrointestinal bleeding within last 3 months prior to enrolment
•oMalignancy with high risk of bleeding
•oRecent unresolved brain of spinal injury
•oSpinal or ophthalmic surgery within last 3 months prior to enrolment
•oIntracranial haemorrhage
•oEsophagal varices
•oAtriovenous malformations with high risk of bleeding
•oVascular aneurysms
•oMajor intraspinal or intracerebral vascular abnormalities
•Hypersensitivity or contraindications to edoxaban
•Requirement for dual-antiplatelet therapy (DAPT) within 1 month prior to randomization.
•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 disease
•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

发起方

Thoraxcentrum Erasmus MC