Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to first ICD shock following LVAD implant
研究概览
简要总结
We propose to study a strategy empirically applied for the past 6 months at a high volume LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative device programming strategy to maximize battery longevity, avoid inappropriate implantable cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in overall shock burden, and potentially avoid unnecessary device generator changes prior to transplant. Avoiding CIED (cardiac implantable electronic device) change out device procedures prior to transplant is desirable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Advanced Heart Failure
- •Scheduled for Heartmate II LVAD implant
- •With existing ICD
排除标准
- 未提供
研究组 & 干预措施
Ultra Conservative ICD Programming
ICD will be set to ultra conservative settings post LVAD implant.
干预措施: Ultra Conservative ICD Programming (Other)
Traditional ICD Programming
ICD will be set to pre-LVAD settings post LVAD implant.
干预措施: Traditional ICD Programming (Other)
结局指标
主要结局
Time to first ICD shock following LVAD implant
时间窗: Within 12 months following LVAD implant
次要结局
- Frequency of ICD generator change prior to definitive therapy(Within 12 months following LVAD implant)
- Hospitalization frequency for decompensated congestive heart failure(Within 12 months following LVAD implant)
- Cardiac implantable electronic device (CIED) battery voltage/estimated longevity changes(Within 12 months following LVAD implant)
- Frequency of anti-tachycardia pacing (ATP) therapy administration for appropriate or inappropriate arrhythmia detection(Within 12 months following LVAD implant)
- Frequency of arrhythmic syncope(Within 12 months following LVAD implant)
- Determine survival to heart transplantation following LVAD implant(Within 12 months following LVAD implant)
研究者
Christopher Ellis
Assistant Professor
Vanderbilt University Medical Center