NL-OMON52989招募中3 期
on-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes - NOAH * AFNET 6
Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork]0 个研究点目标入组 75 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
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
- 65 至 99（—）
入选标准
- •-Pacemaker, defibrillator or insertable cardiac monitor implanted for any
- •reason with feature of detection of AHRE, implanted at least 2 months prior to
- •randomisation.
- •-AHRE detection feature activated for adequate detection of AHRE
- •-AHRE (* 170 bpm atrial rate and * 6 min duration) documented by the implanted
- •device via its atrial lead and stored digitally.
- •Any AHRE episode recorded is potentially eligible, but AHRE episodes detected
- •in the first 2 months after implantation of a new device involving placement or
- •repositioning of atrial electrodes are not eligible. AHRE episodes recorded in
- •the first two months after a simple *box change* operation, i.e. exchange of a
- •pacemaker or defibrillator device without exchange or repositioning of atrial
- •electrodes, are eligible.
- •-Age * 65 years
- •-In addition, at least one of the following cardiovascular conditions leading
- •to a modified CHA2DS2VASc score of 2 or more:
- •--Age * 75 years,
- •--heart failure (clinically overt or LVEF < 45%),
- •--arterial hypertension (chronic treatment for hypertension, estimated need
- •for continuous antihypertensive therapy or resting blood pressure 145/90 mmHg),
- •--diabetes mellitus,
- •--prior stroke or transient ischemic attack (TIA),
- •--vascular disease (previous myocardial infarction, peripheral,
- •carotid/cerebral, or aortic plaques on transesophageal echocardiogram [TEE]).
- •-- Provision of signed informed consent
排除标准
- •- Patients with history of overt AF or atrial flutter
- •- patients with a clear contraindication for oral anticoagulation,
- •- patients with a clear need for oral anticoagulation,
- •- patients with indication for long-term antiplatelet therapy other than
- •acetylsalicylic acid (ASA) or a need for treatment with any antiplatelet agent
- •in addition to edoxaban, especially dual antiplatelet therapy (DAPT), are not
- •suitable for NOAH - AFNET 6.
研究者
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