EUCTR2021-000442-18-PL进行中（未招募）1 期
Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions (STOP CLOT Trial) - STOP CLOT
ational Institute of Cardiology0 个研究点目标入组 410 人开始时间: 2021年6月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 410
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age above 18 years
- •2.Planned treatment of mitral regurgitation with MitraClip implantation or planned left atrial appendage closure with Watchman Left Atrial Appendage Closure Device (Boston Scientific) or Amplatze LAA ocluder (Abbott)
- •3.The patient is willing to comply will all study procedures
- •4.The patient is willing to sign informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 164
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 246
排除标准
- •1.Pregnant or breast feeding women or women with childbearing potential who do not agree to use at least two contraceptive measures (oral contraconception, mechanical contraconception, approved contraceptive implant, intrauterine device, tubal ligation) The criterion does not apply to postmenopausal women (defined as at least one year of no menstrual periods) at least 2 years prior to the enrollment or women who underwent surgical sterilization procedure. Otherwise female younger that 55 years must have negative pregnancy test within 24 hours prior to randomization.
- •2.Congenital or acquire bleeding disorders (i.e.diagnosed thrombophilia, bleeding diathesis)
- •3.INR > 1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists.
- •4.Last dose of new oral anticoagulant < 48 hours prior to the procedure.
- •5.Last dose of low molecular weight heparin <12 hours prior to the procedure.
- •6.Contraindications to MR imaging (i.e. claustrophobia, ferromagnetic metalic prostheses)
- •7. Implanted cardiac devices for electrotherapy if:
- •- device or leads are labeled as MR unsafe
- •- the patient has implanted CRT or device with epicardial leads
- •- left disconnected electrodes or non-functional or damaged devices including those within abdominal wall
- •- the patient is pacemaker dependant
- •- the device was implanted or exchanged within 6 weeks prior to the MR examination
- •- device mulfunction identified during the control performed immediately prior to the MR examination
- •- low voltage of the device battery - the battery on the examination day should have at least 30% of the voltage value between the nominal value and elective replacement indicator (ERI) value, or the expected battery life calculated by the device should equal or exceed one year.
研究者
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