Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UMC Utrecht
- 入组人数
- 130
- 试验地点
- 8
- 主要终点
- Differences in % of patients with succesfull LV lead location
研究概览
简要总结
Cardiac resynchronization therapy (CRT) is an established pacemaker therapy for patients with symptomatic chronic heart failure, but is hampered by a non-response rate of 30-40%. Optimising left ventricular (LV) lead placement is the cornerstone of improving treatment. The optimal location for the lead is remote from scar but within segments demonstrating late electromechanical activation. The present study aims to investigate the efficacy and clinical effect of the use of real-time guided lead placement using cardiac MRI and fluoroscopy in a blinded, multicenter, randomized controlled trial.
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
- Double (Participant, Outcomes Assessor)
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
- •Heart failure with LV ejection fraction ≤ 35%;
- •New York Heart Association class II, III, or IV (ambulatory);
- •Optimal medical treatment that is tolerable;
- •Left bundle branch block (LBBB) and QRS ≥ 130 ms, OR non-LBBB and QRS ≥ 150 ms.
排除标准
- •Pregnancy or lactation;
- •Subjects with impaired renal function (severe renal insufficiency, GFR < 30 ml/min/1.73m2);
- •Atrial fibrillation or atrial fibrillation during MRI
- •Documented allergic reaction to gadolinium;
- •Impossibility to undergo an MRI scan;
- •Participation in another clinical study that prohibits any procedures other than standard.
结局指标
主要结局
Differences in % of patients with succesfull LV lead location
时间窗: Direct post-CRT
Lead location, defined as being within, adjacent, or remote from the pre-defined target.
次要结局
- Change in Kansas City Cardiomyopathy Questionnaire(6, 12 and 24 months)
- Change in EQ-5D-5L(6, 12 and 24 months)
- Change in reverse remodelling and volumetric response(6 months)
- Health Technology Assessment(24 months)
- Change in CRT response score(12 months)
研究者
M. Meine
Principal Investigator (MD, PhD)
UMC Utrecht