Optimize RV Selective Site Pacing Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 205
- 试验地点
- 22
- 主要终点
- The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up
研究概览
简要总结
The purpose of the Optimize RV study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of select site pacing is to improve how the heart contracts when paced in the ventricle. By pacing in select sites, it is possible to better copy the natural pattern of contraction of the heart.
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
- Single (Participant)
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
- •Subjects that are expected to be paced in the right ventricle (RV) greater than 90 percent of the time
- •Subjects with an ejection fraction of greater than 40 percent within 3 months prior to enrollment
- •Subjects greater than 18 yrs of age
- •Subjects that are indicated for a dual chamber pacemaker
- •Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle
排除标准
- •Subjects indicated for cardiac resynchronization therapy (CRT) device (based on American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines)
- •Subjects indicated for an implantable cardiac defibrillator (ICD)
- •Subjects with permanent atrial fibrillation (AF)
- •Subjects with expected managed ventricular pacing turned on
- •Subjects with a previously implanted pacemaker, ICD, or CRT device
- •Subjects with an myocardial infarction (MI) within 3 months prior to enrollment
- •Subjects that received bypass surgery within 3 months prior to enrollment
- •Subjects that had valve replacement within 3 months prior to enrollment
- •Subjects where a RV lead cannot be placed, (i.e., complex congenital heart disease
- •Subjects with a mechanical right heart valve
- •Women who are pregnant or nursing
- •Significant co-morbidity preventing study completion
- •Terminal conditions with a life expectancy of less than two years
- •Participation in another study that would confound the results of this study
结局指标
主要结局
The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up
时间窗: Baseline and 24 months
Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.
次要结局
- The Change in LVEF From Two Week Visit to Two Year Follow-up(Baseline and 24 months)
- The Change in Six-minute Hall Walk Distance(Baseline and 24 months)
- The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up(Baseline and 24 months)
- Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up(Baseline and 24 months)
- Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up(Baseline and 24 months)