NCT00944125终止不适用
Dual Site LV Pacing Study: Prospective Randomized Blinded Crossover Study of Patients Meeting Current CRT-D Indication to be Implanted With Dual LV Pacing Leads and Paced Chronically for at Least 6 Months Post-implant.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in Left Ventricular End Systolic Volume (LVESV)
研究概览
简要总结
The purpose of this study is to compare Dual LV (left ventricular) pacing to standard single LV pacing (BiV pacing) to see if Dual LV pacing:
- Improves the way the heart's left ventricle functions
- Decreases the number of hospital and clinic visits for heart failure related symptoms
- Slows the rate patients experience certain heart failure symptoms
- Reduces uncoordinated heart contractions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate or severe heart failure, defined as NYHA Class III-IV despite optimal pharmacological heart failure therapy
- •On heart failure medical regimen (beta blockers and ACE-I or ARB's) for at least one month before randomization
- •A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a QRS duration > 120 ms
- •Left ventricular ejection fraction (LVEF) < 35% or equal
- •Willing and capable of undergoing the device implant procedure and participating in all testing associated with this clinical study
- •Have a life expectancy of more than 180 days, per physician discretion
- •Age 40 or above, ensuring of legal age to give informed consent specific to state and national law
排除标准
- •Have had previous cardiac resynchronization therapy or a previous coronary venous lead
- •Unable to perform a Six-Minute Hall Walk (6MHW) Test
- •Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention)without CHB or planned AVJ ablation prior to randomization
- •Have an atrial tachyarrhythmia that is persistent (i.e. can be terminated with medical intervention, but does not terminate spontaneously) without planned and successful cardioversion prior to randomization (patients with unsuccessful cardioversions and no AVJ Ablation will be exited.)
- •Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
- •Have a mechanical tricuspid prosthesis
- •Has severe aortic or mitral stenosis
- •Enrolled in any concurrent study that may confound the results of this study
- •Patients who are or suspect they may be pregnant or plan to become pregnant
结局指标
主要结局
Change in Left Ventricular End Systolic Volume (LVESV)
时间窗: At 6 months to one year
The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient.
次要结局
未报告次要终点
研究者
研究点 (3)
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