EUCTR2017-000058-21-DE进行中（未招募）1 期
eft atrial appendage CLOSURE in patients with Atrial Fibrillation at high risk of stroke and bleeding compared to medical therapy: a prospective randomized clinical trial - CLOSURE-AF-DZHK16
Charité – Universitätsmedizin Berlin, Campus Benjamin Franklin0 个研究点目标入组 970 人开始时间: 2017年8月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 970
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
- •- Signed Written Informed Consent
- •- Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)
- •- CHA2DS2VASc-Score =2
- •- High risk of bleeding under oral anticoagulation or contraindication for (N)OAC therapy, in particular patients with at least one of the following conditions:
- •*HAS-BLED-Score =3
- •*Prior intracranial/intraspinal bleed, intraocular bleed compromising vision (BARC: type 3c)
- •*Hemorrhagic/bleeding complication fulfilling BARC type 3a or 3b: gastrointestinal tract, genitourinary tract or respiratory tract bleeding, where the patient is considered to be at a persistently increased risk of bleeding, e.g. the cause of bleeding cannot be successfully eliminated
- •*Chronic kidney disease with eGFR 15-29 ml/min/1.73 m2
- •* Any recurrent bleeding making chronic anticoagulation not feasible
- •- Subject eligible for an LAA occluder device
- •- Age =18 years
- •- Willing and capable of providing informed consent, participating in all associated study activities
- •- negative SARS-CoV-2 PCR test (no longer than 48 hours prior to randomization in outpatients or not older than 14 days in continuously hospitalized patients without signs of COVID-19 infection) or negative SARS-CoV-2 rapid antigen test (no longer than 24 hours prior to randomization)
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 700
排除标准
- •- Absolute contraindication to acetylsalicylic acid
- •- Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis
- •- Symptomatic carotid disease (if not treated)
- •- Complex aortic atheroma with mobile plaque (Kronzon classification grade V)
- •- Heart transplant
- •- Active infection or symptoms suggestive of COVID-19 infection or active endocarditis or other infections resulting in bacteremia
- •- Cardiac Tumor
- •- Severe liver failure (Child–Pugh class C or liver failure with coagulopathy)
- •- Severe renal failure (GFR <15 ml/min/1.73m2 or current requirement for dialysis (defined as current, regular renal replacement therapy performed at least weekly (including hemodialysis and peritoneal dialysis) within the last 30 days))
- •- Pregnancy or breastfeeding
- •- For female patients of reproductive potential: Unwilling to agree to use a highly effective method of contraception (Pearl index <1) throughout the study period
- •- Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial.
- •- Known terminating disease with life expectancy <1 year (including those with end-stage heart failure)
- •- Subjects, who are committed to an institution due to binding official or court order
- •- Subject who is dependent on the Site, the Site Investigator, any sub-investigator, his/her representative and/or the sponsor
- •- Persons who are not proficient in the German language
- •- Unstable/ not fully recompensated acute heart failure corresponding to NYHA class III and/or IV
- •-Subject with known antiphospholipid syndrome
研究者
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