NCT02726698已完成不适用
Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation - An Observational Exploratory Study on Pathophysiological Mechanisms of AF Progression and on the Role of LinQ/CareLink Guided Patient Tailored Therapy in Patients With Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 9
- 主要终点
- Progression of AF burden
研究概览
简要总结
The purpose of this study is to study clinical factors and (blood) biomarkers related to progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with special reference to hypercoagulability. All patients will be continuously monitored for their atrial rhythm to assess AF progression, either through an implantable loop recorder (Reveal LinQ) or via the atrial lead of a cardiac implantable electronic device (CIED), both in combination with the CareLink home monitoring system. Remote monitoring and interrogation will be installed and used on a daily basis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New onset or history of paroxysmal, self-terminating AF documented as:
- •AF on ECG or Holter-recording or loop recorder
- •Subclinical AF detected in implantable cardiac devices (atrial read > 190 beats per minute, lasting > 6 minutes).
- •Prior history of self-terminating AF is allowed;
- •Able and willing to sign informed consent for the registry;
- •Able and willing to undergo implantation of an implantable loop recorder (in patients without a CIED);
- •In patients already on oral anticoagulation drugs, the following inclusion criteria need to be met (to allow for safe temporary interruption of anti-thrombotic treatment for coagulation phenotyping):
- •CHA2DS2-VASc score ≤5 (history of Congestive heart failure, Hypertension, Age ≥ 75 years (doubled), Diabetes mellitus,Stroke/transient ischemic attack (doubled), Vascular disease, Age 65-75 years, female Sex);
- •No other indication for oral anticoagulation (e.g. mechanical valve prosthesis);
- •Patient is willing to temporarily stop oral anticoagulation drugs (OAC).
排除标准
- •Non-self-terminating, persistent AF;
- •Deemed unsuitable or not willing to undergo implantation of loop recorder (in patients without a CIED);
- •Refusing to temporarily stop OAC for coagulation phenotyping (in patients already on OAC before inclusion in this study);
- •On waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year;
- •Expected to start with amiodarone;
- •Pregnancy;
- •Life expectancy of less than 2.5 years.
结局指标
主要结局
Progression of AF burden
时间窗: 2.5 years
次要结局
- Major Adverse Cardiac and Cerebrovascular Events(2.5 years)
- Change in therapy due to continuous rhythm monitoring with the LinQ/Carelink system(2.5 years)
研究者
I.C. Van Gelder
Prof.dr.
University Medical Center Groningen
研究点 (9)
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