MRI Allocation of Pacing Targets in Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 5
- 主要终点
- Determination of response to image guided placement of cardiac ventricular pacing leads in cardiac resynchronization therapy (CRT)
研究概览
简要总结
This randomized controlled trial will assess a cardiac MRI derived 4D digital cardiac model to optimized left and right ventricular lead delivery to improve response to cardiac resynchronization therapy.
详细描述
Regional mechanical delay, myocardial scar, and inter-lead distance have each been demonstrated to be relevant variables for the realization of optimal response to cardiac resynchronization therapy (CRT). Pilot study results have suggested clinical feasibility and potential value from LV and RV lead navigation aimed at optimizing these combined variables. A computer software program has been developed to deliver an interactive, 4D digital heart model of mechanical dyssynchrony and myocardial scar to guide LV and RV CRT lead delivery to optimal targets. This multi-center randomized clinical trial has been designed to assess the feasibility, safety and clinical impact of LV-RV lead navigation using a web-deployed 4D cardiac model.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age ≥ 18 years.
- •Ejection fraction ≤ 35 %.
- •LBBB with QRS duration ≥ 120 msec.
- •NYHA class II-IV.
- •On maximum tolerated heart failure medication therapy ≥ 6 weeks.
- •Clinically accepted for CRT device implantation.
排除标准
- •Failure to provide consent.
- •CCS class III-IV angina.
- •Recent Q-wave myocardial infarction or revascularization procedure ( ≤ 3 months).
- •Atrial fibrillation at time of randomization >6 weeks in duration
- •Standard contra-indications to MRI.
- •Documented severe allergy to intravenous contrast dye ( iodinated CT contrast or Gadolinium MRI contrast).
- •Estimated Glomerular Filtration Rate (eGFR) ≤ 45 ml/min/m
- •Patient is pregnant.
研究组 & 干预措施
Image guided delivery of pacing leads
4D model-guided placement of LV and RV leads to optimal myocardial targets, as derived from pre-procedural Cardiac MRI
干预措施: 4D Model guided delivery of cardiac pacing leads (Procedure)
Standard delivery of pacing leads
Standard LV and RV lead placement
干预措施: Standard CRT lead delivery (Procedure)
结局指标
主要结局
Determination of response to image guided placement of cardiac ventricular pacing leads in cardiac resynchronization therapy (CRT)
时间窗: 6 months
Cardiac Resynchronization Therapy (CRT) response will be defined as a change in the Left Ventricular Ejection Fraction measured at 6 months post CRT device implant by MUGA (multigated acquisition scan / wall motion study).
次要结局
- All-cause mortality(12 months)
- Heart failure hospital admissions(12 months)
- improvement in 6-minute hall walk ≥ 30 meters or ≥ 10%(6 months)
- Improvement in New York Heart Association (NYHA) functional class by ≥ 1(6 months)
- Improvement in Quality of Life (QOL) score by ≥ 10 points(6 months)
- Rate of concordant lead delivery to the "optimal myocardial target"(6 month)
- Total procedural time(6 month)
- Fluoroscopy dose and exposure time(6 month)
- Procedural complications(6 months)
- Device complications(6 months)
研究者
James White
Principal Investigator
University of Calgary