Glotzer Taya V, Daoud Emile G, Wyse D George, Singer Daniel E, Holbrook Reece, Pruett Khadeeja, Smith Kenneth, Hilker Christopher E
Hackensack University Medical Center, Hackensack, NJ, USA.
J Interv Card Electrophysiol. 2006 Jan;15(1):9-14. doi: 10.1007/s10840-006-7622-y.
Sustained atrial fibrillation (AF) is a common risk factor for stroke. While intermittent AF also appears to pose a substantial stroke risk, the quantitative relationship between the percentage of time spent in AF and stroke risk is poorly specified and "intermittent" AF is not the same as paroxysmal AF. Improved assessment of the impact of AF burden on stroke risk will allow more targeted and safer use of antithrombotic therapy.
The primary objective of this study is to determine if AT/AF (all device detected atrial tachyarrhythmias, including atrial flutter, atrial fibrillation, and atrial tachycardia) burden over a 30 day period is an independent predictor of the occurrence of ischemic stroke, transient ischemic attack (TIA) and/or systemic embolism in subjects not receiving anticoagulation therapy. TRENDS is a prospective, post-market, non-randomized, multicenter study designed to enroll 3100 subjects who have an independent Class I/II indication for cardiac rhythm device implantation and who have demographic features suggestive of an increased risk for thromboembolic complications related to AT/AF. All implanted devices will have the ability to collect long-term AT/AF burden trending data and will be equivalently programmed to ensure consistent data collection. All subjects will be followed with device interrogations every 3 months and clinic visits every 6 months for 1 year. Subjects with a documented history of AT/AF prior to enrollment and those who develop AT/AF during the 12-month follow-up will be followed until the last subject enrolled in the study has completed their 24-month follow-up.
The results of the TRENDS study should help clarify the implications of data retrieved from an implantable device with regard to the risk for thromboembolic complications from atrial arrhythmias, even in the absence of symptoms.
持续性心房颤动（AF）是中风的常见危险因素。虽然间歇性AF似乎也构成重大中风风险，但AF持续时间百分比与中风风险之间的定量关系尚不明确，且“间歇性”AF与阵发性AF不同。改善对AF负荷对中风风险影响的评估将有助于更有针对性且更安全地使用抗血栓治疗。
本研究的主要目的是确定在30天期间的AT/AF（所有设备检测到的房性快速性心律失常，包括心房扑动、心房颤动和房性心动过速）负荷是否是未接受抗凝治疗的受试者发生缺血性中风、短暂性脑缺血发作（TIA）和/或系统性栓塞的独立预测因素。TRENDS是一项前瞻性、上市后、非随机、多中心研究，旨在招募3100名有心脏节律设备植入的I/II类独立适应症且有人口统计学特征提示与AT/AF相关的血栓栓塞并发症风险增加的受试者。所有植入设备都将有能力收集长期AT/AF负荷趋势数据，并将进行等效编程以确保一致的数据收集。所有受试者将每3个月进行一次设备问询，每6个月进行一次门诊随访，为期1年。入组前有AT/AF记录史的受试者以及在12个月随访期间发生AT/AF的受试者将接受随访，直到研究中最后一名入组受试者完成其24个月随访。
TRENDS研究的结果应有助于阐明从可植入设备检索到的数据对于房性心律失常血栓栓塞并发症风险（即使无症状）的意义。
