Study of the Effects of Cardiac Resynchronization Therapy (CRT) and Left Ventricular Assist Devices (LVAD) Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Ventricular Tachycardia Episodes
研究概览
简要总结
Cardiac resynchronization therapy (CRT) or biventricular pacing is a useful treatment for heart failure and those suffering from arrhythmias. The purpose of this research study is to determine the effect left-ventricular pacing has on patients who have a ventricular assist device.
详细描述
As part of the study participation the following two visits will be completed as listed below.
Baseline Visit: The following procedures will be conducted at this visit:
- Review of past medical history and medical records;
- A limited echocardiogram will be performed. This is a test that uses ultrasound to evaluate the size of the heart and how well the heart is pumping blood.
- The investigators will use a computer-like device, called a programmer, that "talks" to the CRT device using radio signals or by using wanded telemetry to adjust the CRT device's programmed settings. The left ventricular lead of your device will be turned off. The defibrillator will continue to function and back-up pacing will continue if needed.
- Complete the Kansas City Cardiomyopathy Questionnaire (KCCQ).
- A 6 minute walk test will be done.
Regularly Scheduled Clinic Visit: At the next regularly scheduled Left Ventricular Assist Devices (LVAD) clinic visit, approximately 4 weeks after the baseline visit, the following procedures will be done:
- A second limited echocardiogram.
- The investigator will use a computer-like device, called a programmer, that "talks" to the CRT device using radio signals or by using a wand to obtain a report that will give the current program settings and any heart rhythm events that have occurred since the last CRT device was checked. Once the information from the CRT is obtained, the study doctor will reprogram the device to its original settings.
- Complete the Kansas City Cardiomyopathy Questionnaire (KCCQ).
- A 6 minute walk test will be done.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Presence of LVAD support and CRT device with working LV lead in patients > 18years of age
- •Left ventricular pacing at time of enrollment
排除标准
- •LV lead dysfunction
- •Prior AV node ablation
- •Presence of total heart block
- •Presence of significant bradycardia/lack of underlying rhythm
- •Inability to complete 6 minute walk test
- •Inability to return to clinic for repeat assessment
- •Any LVAD programmed speed change within the prior 30 days
- •Any CRT programming changes within the prior 30 days
结局指标
主要结局
Number of Ventricular Tachycardia Episodes
时间窗: Change in baseline to 30 days
At baseline and again at 30 days CRT device interrogation will be done to count the number of ventricular tachycardia episodes with LV pacing on and off.
Change in echocardiographic parameters
时间窗: Change in baseline to 30 days
A comparison of the echocardiogram completed at enrollment and at 30 days.
Quality of Life
时间窗: Change in baseline to 30 days
A comparison of the questionnaires completed at enrollment and at 30 days.
6 minute walk distance
时间窗: Change in baseline to 30 days
A trained staff member will supervise participants in the completion of a 6 minute walk test. They will be instructed to walk on a level surface, on a clearly marked indoor course. heart rate and oxygen level will be monitored. The total distance completed at the end of 6 minutes will be noted.
次要结局
未报告次要终点