NCT00757666终止不适用
Assessment of Proper Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 566
- 试验地点
- 2
- 主要终点
- Mean Change in Functional Capacity (Peak VO2).
研究概览
简要总结
The APPROPRIATE study will compare differences in functional capacity (peak VO2) between chronotropically incompetent patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or an accelerometer (motion-based).
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
- Double (Participant, Outcomes Assessor)
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
- •Meets or met current pacemaker implantation indications
- •Willing and capable of providing informed consent for participation
- •Receiving a dual-chamber pacemaker or previously received a dual-chamber pacemaker with active atrial and ventricular leads
- •Plans to remain in the long-term care of his/her enrolling physician and is available for study follow-up for three months post-enrollment
排除标准
- •Mobitz II second degree heart block
- •Third degree heart block
- •Chronic atrial fibrillation or uncontrolled atrial arrhythmias within the past 90 days prior to consent
- •Neuromuscular, orthopedic, or vascular disability that prevents normal walking or weight carrying (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker)
- •A symptom-limited exercise protocol is thought to be dangerous or contra-indicated, including but not limited to changing pattern of chest discomfort or uncontrolled arrhythmias
- •Pulmonary disease as defined by any one of the following:
- •Forced Vital Capacity (FVC) or Forced Expiratory Volume in one second (FEV1) < 60% of predicted values
- •Use of two or more pulmonary inhalers
- •Use of supplemental oxygen
- •Chronic use of oral steroids for pulmonary disease treatment
- •Life expectancy is less than 12 months due to other medical conditions, per physician discretion
- •Has or indicated for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
- •Currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study.
- •Younger than 18 years of age
- •Pregnant or planning to become pregnant during the study (method of assessment upon physician's discretion)
- •Unable or unwilling to comply with the protocol requirements
结局指标
主要结局
Mean Change in Functional Capacity (Peak VO2).
时间窗: 1 month and 2 months post-implant
The APPROPRIATE Study compared differences in functional capacity (peak VO2) between CI patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or by an accelerometer (motion-based) sensor. The mean change in functional capactity will be compared against baseline; changes from baseline will be measured.
次要结局
- Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test(2 months post-implant)
- Metabolic Chronotropic Relationship (MCR) Slope(1 month and 2 months post-implant)
- Exercise Time(1 month and 2 months post-implant)
- VO2 at Ventilatory Threshold(1 month and 2 months post-implant)
研究者
研究点 (2)
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