Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for CRT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 7
- 主要终点
- Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec)
研究概览
简要总结
The SYNSEQ study intends to assess the positive left ventricular dP/dt max achieved by MultiSpot LV pacing (either simultaneously or sequentially) in comparison to the response achieved by the current (standard) BiV pacing configuration in patients indicated/recommended for cardiac resynchronization therapy.
详细描述
The following pacing configurations will be evaluated.
Biventricular pacing (BiV):
Pacing will be performed on one LV electrode pair, (at 3 different longitudinal locations), and on the tip of the RV-lead. In total, three different pacing BiV settings will be evaluated. Configuration 1: RV + LV lateral Apex, Configuration 2: RV + LV lateral Mid, Configuration 3: RV + LV lateral Base (Reference: Standard CRT)
MultiSpot simultaneous LV-ventricular pacing (MultiSpot-SYN):
Pacing will be performed on 3 electrodes on the LV wall, placed at different longitudinal locations, and on the tip of the RV-lead simultaneously. Configuration 4: RV + LV lateral Apex + LV lateral Mid + LV lateral Base
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Subject is indicated or recommended for CRT-P or CRT-D device according to current applicable ESC/AHA guidelines
- •Subject is in sinus rhythm
- •Subject receives optimal heart failure oral medical therapy
- •Subject is willing to sign the informed consent form
- •Subject is 18 years or older
排除标准
- •Subject has permanent atrial fibrillation/flutter or tachycardia
- •Subject has pure right bundle branch block (= no additional left ventricular conduction delays)
- •Subject has left bundle branch block and QRS-duration of > 150 ms and no sign of myocardial scar indicated by late gadolinium enhancement MRI
- •Subject experienced recent myocardial infarction, within 40 days prior to enrollment
- •Subject underwent valve surgery, within 90 days prior to enrollment
- •Subject is post heart transplantation, or is actively listed on the transplantation list
- •Subject is implanted with a left ventricular assist device
- •Subject has severe renal disease (up to physicians discretion)
- •Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
- •Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)
- •Subject has complex and uncorrected congenital heart disease
- •Subject has a mechanical heart valve
- •Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
- •Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager
结局指标
主要结局
Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec)
时间窗: Participants were followed for the time of the EP procedure, which had a median duration of 48 min
LV dP/dt max is a measurement of the initial velocity of myocardial contraction and is derivative of the LV-pressure. The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as (\[median dP/dt max during pacing On\] - (median baseline dP/dt max during pacing Off\])/\[median dP/dt max during pacing Off\]. From all percentage changes for a given pacing configuration and subject, a regression analysis is performed to determine the regression predicted highest percentage change. The presented percentage change is the average over all subjects.
次要结局
- Correlation Between Percentage Change LV dP/dt Max and Percentage Change Blood Pressure(Participants were followed for the time of the EP procedure, which had a median duration of 48 min)
- Correlation Between Percentage Change LV dP/dt Max and Percentage Change Non-Invasive Blood Pressure(Participants were followed for the time of the EP procedure, which had a median duration of 48 min)
- Correlation Between Percentage Change LV dP/dt Max and Q-LV Ratio(Participants were followed for the time of the EP procedure, which had a median duration of 48 min)
- Correlation Between Percentage Change LV dP/dt Max and % Change QRS Width(Participants were followed for the time of the EP procedure, which had a median duration of 48 min)