Cardiac Rehab Retrospective Review (CR3)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Number of Arrhythmias (as recorded by clinic or WCD)
研究概览
简要总结
All patients enrolled in the Austrian LifeVest Registry will be retrospectively screened for successfully completed ambulatory or stationary rehabilitation program. Baseline characteristics, complete rehab data, outcomes and follow up data, as well as wearable cardioverter defibrillator(WCD)-derived data will be collected from these patients.
Specifically, performance data from the start of the exercise training (ET) will be compared to the end of ET; including type of training, exertion, time and duration will be collected. In addition, WCD recorded data such as automatically and manually recorded ECGs, compliance, and TRENDS data will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Prescribed WCD as part of the Austrian WCD registry population from 2014-2018
- •Partial (>50%) or full completion of a rehabilitation program when wearing the WCD in Austria
- •≥18 years old and able to give informed consent
排除标准
- 未提供
结局指标
主要结局
Number of Arrhythmias (as recorded by clinic or WCD)
时间窗: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the following data on Arrhythmias captured via WCD or Surface ECG will be collected: * Atrial tachycardia * Ventricular tachycardia * Bradycardia
Number of inadequate WCD alarms (as recorded by WCD) per patient
时间窗: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inadequate WCD alarms will be recorded
Number of other issues with WCD
时间窗: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, every data with an issue with WCD disturbing the normal rehabilitation activities will be collected.
Number of adequate WCD alarms (as recorded by WCD) per patient
时间窗: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of adequate WCD alarms will be recorded
Number of patients with abnormal blood pressure (measured in mmHg)
时间窗: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the following data for abnormal blood pressure will be collected: * Occurrence of Hypotension * Occurrence of Hypertension
Number of patients with Syncopes/Presyncopes
时间窗: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, data of Syncopes or Pre-Syncopes will be collected.
Number of patients with inappropriate WCD Shocks
时间窗: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inappropriate WCD shocks (captured via LifeVestNetwork) will be collected.
Number of patients with appropriate WCD Shocks
时间窗: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of appropriate WCD shocks will be collected.
Number of other Adverse Events
时间窗: 3 months
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, other adverse events recorded by staff during therapy session that stopped ET session (notWCD specific) will be collected.
次要结局
- Performance in ergometry - measured in watts (difference between initial Evaluation and final Evaluation)(3 months)
- Body weight - measured in kilogram (difference between initial Evaluation and final Evaluation)(3 months)
- diastolic dysfunction (measured in grade)(3 months)
- Body Position derived from the WCD(3 months)
- Step count derived from the WCD (steps/day)(3 months)
- Intraventricular septum (diastolic, measured in mm)(3 months)
- Difference in physical exercise capacity - measured in METs(3 months)
- Body Mass Index (BMI, weight and height will be combined to report BMI in kg/m^2); (difference between initial Evaluation and final Evaluation)(3 months)
- Blood pressure - measured in mmHg (difference between initial Evaluation and final Evaluation)(3 months)
- Size of the Left atrial (measured in mm)(3 months)
- Left ventricular ejection fraction - measured in % (difference between initial Evaluation and final Evaluation)(3 months)
- Left ventricular end diastolic diameter (measured in mm)(3 months)
- Right atrial diameter (measured in mm)(3 months)
- Heart rate derived from the WCD (measured in beats per Minute)(3 months)