Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- dP\dt max response to different ventricular lead pacing sites
研究概览
简要总结
Exploratory, prospective, interventional, non-randomized single-center research study to compare metrics derived from 2 or 3-D reconstructions of lead movement, bioimpedance and VCG to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant. Pacing sites and contractility data will be compared to pre operative cardiac ultrasound and MRI metrics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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 CRT or CRT-D device according to current applicable ESC/AHA guidelines
- •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). No documented AF-episodes allowed during the last 2 weeks prior to inclusion.
- •Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or ARB and Beta Blockers), and is on a stable medication scheme for at least 2 months prior to enrollment.
- •Subject (or the legal guardian) is willing to sign informed consent form
排除标准
- •Permanent atrial fibrillation/ flutter or tachycardia
- •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
- •Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
- •Implanted with a left ventricular assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
- •On chronic renal dialysis, or with 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)
- •On continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions a week)
- •Severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period)
- •Complex and uncorrected congenital heart disease
- •Mechanical heart valve
- •Breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
- •Enrolled in one or more concurrent studies that would confound the results of this study
- •Already implanted with pacemaker (CRT, CRT-D, ICD) and needs replacement
结局指标
主要结局
dP\dt max response to different ventricular lead pacing sites
时间窗: 6 months
To compare metrics derived from 2 or 3-D reconstructions of lead movement to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant Main objective is to identify the optimal LV pacing site within each patient where the force of contraction during BiV pacing is maximized and to assess the feasibility of a non-invasive sensor to identify this optimal site.
次要结局
- Metrics derived from 2/3-D reconstructions of lead movement and Force-Interval-Relation(6 months)
- Metrics derived from 2/3-D reconstructions of lead movement and CardioGuide Motion Map(6 months)
- Lead movements and electrical measures(6 months)
研究者
Erik Kongsgaard
MD, Ph.d
Oslo University Hospital