Targeted Left Ventricular Lead Placement for Cardiac Resynchronization Therapy, a Randomized Trial Comparing an Active Fixation Bipolar Left Ventricular Lead and Passive Fixation Quadripolar Leads
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Echocardiographic response
研究概览
简要总结
A prospective, randomized and patient-blinded trial comparing an active fixation left ventricular lead with quadripolar passive left ventricular leads. The leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located concordant to target segment and clinical outcome. The patients were followed up for 12 months.
详细描述
A prospective, randomized and patient-blinded trial. The objective was to compare an active fixation left ventricular lead with quadripolar passive left ventricular leads. The left ventricular segment with latest mechanical activation was identified as target segment by radial strain speckle-tracking echocardiography.The leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located concordant to target segment and clinical outcome. The clinical outcomes were assessed by echocardiography, change in New York Heart Association (NYHA) functional class and Minnesota Living With Heart Failure Questionnaire (MLHFQ). The patients were followed up for 12 months.
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)
盲法说明
Patient blinded The echocardiographic analyses were done blinded to type of left ventricular lead.
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
- •Left Ventricular Ejection Fraction (LVEF) ≤ 35 %
- •Electrocardiogram : left bundle branch block (LBBB) and QRS duration >120 ms or non-LBBB and QRS duration ≥150 ms
- •Optimal medical treatment.
排除标准
- •Upgrade procedures due to ventricular pacing
- •No written consensus
结局指标
主要结局
Echocardiographic response
时间窗: Day 0 (baseline). 6 and 12 months after implantation
Changes in left ventricular end-systolic volume (measured in milliliter).
The left ventricular lead long-axis position.
时间窗: At implant (day 0)
Measurement of the distance (millimeter) from the active electrode to coronary sinus. Fluoroscopic measurement in a right anterior oblique (RAO) view.
Ability to achieve a position in a coronary vein located concordant to target segment.
时间窗: At implant (day 0)
The left ventricular lead final position will be compared to the left ventricular target segment. The target segment is determined by radial strain speckle-tracking echocardiography. The lead position is classified as "concordant" or "not concordant".
The left ventricular lead pacing threshold
时间窗: Day 0 (baseline). 2, 6 and 12 months after implantation.
Changes in left ventricular lead pacing capture thresholds, measured in "Volt" with 0.4ms pulse width.
次要结局
- Changes in NYHA functional Class(Day 0 (baseline). 2, 6 and 12 months after implantation)
- Left ventricular lead impedances(Day 0 (baseline). 2, 6 and 12 months after implantation)
- Changes in left ventricular ejection fraction(Day 0 (baseline). 6 and 12 months after implantation.)
- Changes in MLHFQ score(Day 0 (baseline). 2, 6 and 12 months after implantation)