Pacemaker Remote Follow-up Evaluation and Review
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 980
- 试验地点
- 45
- 主要终点
- Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months
研究概览
简要总结
The purpose of the study is to compare remote pacemaker follow-up to current standard of care follow-up. The study will compare the rate of first diagnosis of clinically actionable events between patients who utilize the Medtronic Carelink® Network (Remote arm) versus patients who are followed via routine office visits augmented by transtelephonic monitoring (TTM)(Control arm).
详细描述
The Clinically Actionable Events (CAE) were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The defined events are:
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Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes of greater than 48 hours defined as two consecutive days in which the device records at least 18 hours of AT/AF per day
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Ventricular pacing that has increased by 30 percent (relative) since the last device interrogation
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A sensed ventricular response of greater than 100 beats per minute (BPM) during atrial tachyarrhythmia for at least 20 percent of the time since the previous device interrogation
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Runs of non-sustained ventricular tachycardia (NSVT) greater than 5 beats
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New onset of AT/AF among patients with no history of AT/AF
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Loss of atrial capture
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Loss of ventricular capture
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Increase in atrial pacing voltage threshold greater than 1 volt (V)
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Increase in ventricular pacing voltage threshold greater than 1 volt (V)
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& 11. Significant change in atrial or ventricular lead impedance, defined as any of the following:
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Less than 200 or greater than 2000 ohms (Ω)
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Unstable lead impedance deemed to be clinically actionable
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Greater than 50 percent change in lead impedance since last interrogation
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Elective Replacement Indicator (ERI)/Battery End of Life (EOL) indicators
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been previously implanted with a dual-chamber or single-chamber EnPulse®, Kappa 900®, or Adapta® device
- •Patient agrees to complete all required follow-up transmissions and in-office visits
- •Patient is capable of operating the TTM monitor and Medtronic CareLink monitor
排除标准
- •Patient is an immediate candidate for an implantable cardioverter defibrillator (ICD)
结局指标
主要结局
Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months
时间窗: One year post-enrollment
Clinically Actionable Events (CAE) are 12 events that were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The CAEs consist of several arrhythmias and device performance parameters such as: Atrial Tachycardia/Atrial Fibrillation (AT/AF) and loss of capture.
次要结局
- Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events(One year post-enrollment)
- Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months(One year post-enrollment)
- Percentage of Participants With First Diagnosis of Sensed Ventricular Rate Greater Than 100 Beats Per Minute (BPM) During Atrial Tachycardia/Atrial Fibrillation at 12 Months(One year post-enrollment)
- Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months(One year post-enrollment)
- Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months(One year post-enrollment)
- Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months(One year post-enrollment)
- Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months(One year post-enrollment)
- Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months(One year post-enrollment)
- Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months(One year post-enrollment)
- Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months(One year post-enrollment)
- Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months(One year post-enrollment)
- Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months(One year post-enrollment)
- Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months(One year post-enrollment)