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临床试验/NCT02954380
NCT02954380撤回不适用

The Comparative Efficacy of the Zio Patch vs Implantable Loop Recorder in Atrial Fibrillation

University of Florida2 个研究点 分布在 1 个国家开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Agreement between the assessment of events between the two devices

研究概览

简要总结

The aim of our study is to investigate if LTCM's are superior to implantable loop recorders in detecting atrial fibrillation after pulmonary vein isolation. This study will provide insights on a possible alternative for detection of arrhythmia.

详细描述

Summary Atrial fibrillation (AF) is the most common arrhythmia, increasing in prevalence with age characterized by chaotic contraction of the atrium. An estimated 2.2 million people in the United States and 4.5 million in the European Union have AF.[1,2] AF is associated with heart failure, hemodynamic impairment, and symptoms affecting quality of life. Patients have an increased risk of thromboembolic events, including stroke, resulting in significant morbidity, mortality, and costs. [1-5]

Diagnosis of atrial fibrillation is made via an electrocardiogram (ECG) recording. Any arrhythmia that has the ECG characteristics of AF and lasts sufficiently long for a 12-lead ECG to be recorded, or at least 30 seconds on a rhythm strip, should be considered an AF episode.[6] The diagnosis requires an ECG or rhythm strip demonstrating: 1) "absolutely" irregular RR intervals (in the absence of complete AV block), 2) Absence of distinct P waves on the surface ECG, and 3) an atrial cycle length (when visible) that is usually variable and less than 200 msec. [7]

During the past decade, catheter ablation of atrial fibrillation (AF) has evolved rapidly from an investigational procedure to its current status as a commonly performed ablation procedure in many major hospitals throughout the world. The goal of the ablation is to isolate the pulmonary veins from which in the majority of the population atrial fibrillation originates. During the past several years a large number of meta analyses have been performed in the hope of better defining the efficacy of AF ablation. Overall, the success rate was 77.8% in the ablation arm as compared with 23.3% in the control group.

Catheter ablation has decreased the recurrence of AF by 71% (relative risk 0.29). Several other meta analyses of randomized clinical trials have confirmed these findings [8-12].

Background and Significance Arrhythmia monitoring in patients undergoing atrial fibrillation ablation is challenging. Trans-telephonic monitors (TTMs) are cumbersome to use and provide limited, temporal assessment. Implantable loop recorders may overcome these limitations. The ABACUS study sought to evaluate the utility of implantable loop recorders (ILRs) versus conventional monitoring (CM) in patients undergoing AF ablation. In AF ablation patients, ILR detected more arrhythmias than CM. However, false detection remained a challenge including the inability to the ILR to detect atrial fibrillation less than 2 minutes in duration. The investigators concluded that with adequate oversight, ILRs may be useful in monitoring these patients after ablation. [13] ILR's have been convenient to patients due to the fact that they do not require electrodes or patches. In addition there is no external monitor that must be accompanied with the electrode adhesive pair.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of paroxysmal or persistent atrial fibrillation documented on electrocardiography
  • Patients must already have a Medtronic LINQ ILR as standard of care already implanted as standard of care
  • Patients must be available for at least 7 but maximum of 14 days after patch application
  • Patients must be greater than or equal to 18 years old.

排除标准

  • Patients with a history of permanent atrial fibrillation
  • Patients with an implanted pacemaker or implantable cardioverter defibrillator
  • Patients with cognitive delay and or dementia
  • Patients unable to give Consent.
  • Patients with adhesive allergy

结局指标

主要结局

Agreement between the assessment of events between the two devices

时间窗: 10 days

次要结局

  • Sensitivity, Specificity, PPV, Accuracy and Reliability(10 days)
  • Signal quality(10 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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