NCT01727297已完成不适用
REVEAL AF: Incidence of AF in High Risk Patients
Medtronic Cardiac Rhythm and Heart Failure114 个研究点 分布在 4 个国家目标入组 446 人开始时间: 2012年11月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 446
- 试验地点
- 114
- 主要终点
- 18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes
研究概览
简要总结
This study is to determine, through continuous monitoring with the Reveal implantable cardiac monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high risk for having AF and to understand how physicians manage these patients after AF has been detected. This study will also seek to identify what patient characteristics are most predictive of developing AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 否
入选标准
- •Patient meets the approved indications to receive the Reveal ICM
- •Patient is suspected, based on symptomatology and/or demographics, of having atrial fibrillation or at high risk of having AF, as determined by the clinical investigator
- •Patient has a Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, prior Stroke or transient ischemic attack (TIA) or thromboembolism (doubled) (CHADS2) score ≥ 3 OR has a CHADS2 score = 2 with at least one of the following documented: renal impairment (GFR 30-60 ml/min), sleep apnea, coronary artery disease, or chronic obstructive pulmonary disease. Note: stroke/TIA criterion as part of the CHADS2 score for this trial is limited to either an ischemic stroke or TIA, which occurred more than one year prior to enrollment.
- •Patient is 18 years of age or older
- •Patient has a life expectancy of 18 months or more
- •Patient, or legally authorized representative, is willing to sign and date the consent form
- •Patient is willing and able to be remotely monitored (i.e., eligible for enrollment into the Medtronic CareLink Network)
排除标准
- •Patient has a documented history of AF or atrial flutter
- •Patient had an ischemic stroke or TIA within past year prior to enrollment
- •Patient has a history of a hemorrhagic stroke
- •Patient is currently implanted with an implantable pulse generator (IPG), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), or cardiac resynchronization therapy defibrillator (CRT-D) device
- •New York Heart Association (NYHA) Class IV Heart Failure patient
- •Patient had heart surgery within previous 90 days prior to enrollment
- •Patient had a myocardial infarction (MI) within the previous 90 days prior to enrollment
- •Patient is taking chronic immuno-suppressant therapy
- •Patient is taking an anti-arrhythmic drug
- •Patient is contraindicated for long term anticoagulation medication
- •Patient is taking a long-term anticoagulation medication
- •Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional / psychological diagnosis)
- •Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager
- •Patient has a creatinine clearance <30 ml/min or is on dialysis
研究组 & 干预措施
REVEAL Implantable Cardiac Monitor
Other
干预措施: REVEAL Implantable Cardiac Monitor (Device)
结局指标
主要结局
18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes
时间窗: Implant to 18 months post device insertion
Incidence of adjudicated AF lasting six or more minutes at 18 months. Each arrhythmic episode detected by the patient's Reveal device will be reviewed to determine if it is 1) an actual atrial fibrillation episode, and (2) is at least 6 minutes in duration. The first such episode per patient occurring within 18 months will be utilized to determine the 18 month incidence rate.
次要结局
- Predictors of the Incidence of AF(Time from implant to date of last stored available device data (maximum of 30 months))
- Actions Taken in Response to Awareness of AF(Time from first identified episode of AF to study exit (maximum of 30 months))
研究者
研究点 (114)
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