Left Ventricular MultiSpot Pacing for CRT (iSPOT)
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
- 16
- 主要终点
- Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing
研究概览
简要总结
The purpose of the iSPOT Study is to evaluate the contractility using positive left ventricular (LV) dP/dt max across LV pacing site(s) in patients indicated for cardiac resynchronization therapy (CRT).
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 for cardiac CRT or CRT-D device according to current applicable European Society of Cardiology (ESC)/American Heart Association (AHA) guidelines
- •Subject has a left bundle branch block (LBBB) conduction pattern
- •Subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion and no documented atrial fibrillation (AF) episodes allowed during the last 2 weeks prior to inclusion)
- •Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or angiotensin receptor blockers (ARB) and Beta Blockers), and is on a stable medication scheme for at least 1 month prior to enrollment
- •Subject (or the legal guardian) is willing to sign informed consent form
- •Subject is 18 years or older or as specified minimal age per local law/regulation
排除标准
- •Subject has permanent atrial fibrillation/ flutter or tachycardia
- •Subject experienced recent myocardial infarction (MI), within 40 days prior to enrollment
- •Subject underwent coronary artery bypass graft (CABG) or 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 (LVAD)
- •Subject is on chronic renal dialysis
- •Subject has severe renal disease (defined as estimated Glomerular Filtration Rate (equation provided by Modification of Diet in Renal Disease study): (eGFR) < 30 mL/min/1.73m2)
- •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 one or more concurrent studies that would confound the results of this study
- •Subject is already implanted with a device
结局指标
主要结局
Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing
时间窗: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
Measure the percentage change in positive left ventricular (LV) dP/dt max (mm HG/sec) of multispot LV pacing configuration compared to normal biventricular pacing in patients undergoing a research study, an electrophysiological exploratory procedure or cardiac resynchronization therapy (CRT) implant. 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
- Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Multispot LV Pacing Configuration(Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours)
- Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing(Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours)
- Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values(Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours)
- Use of Non-invasive Measurements to Identify Pacing Configuration With Highest Positive LV dP/dt Max(Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours)
- Within Patient Variability in Positive LV dP/dt Max(Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours)