跳至主要内容
临床试验/NCT02962791
NCT02962791终止不适用

Prospective Randomized Trial Comparing TRIPLE Site ventriculAr Stimulation Versus Conventional Pacing in CRT canDidates: TRIPLEAD Trial

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年10月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
36
试验地点
1
主要终点
Difference from baseline in Left Ventricular End-Systolic Volume

研究概览

简要总结

Cardiac resynchronization therapy (CRT) is a recommended treatment for selected patients with symptomatic heart failure (HF). Although most treated patients show a benefit from CRT, a lack of response is observed for about 25-30% of them whatever the response criteria used either based on the clinical status (NYHA class, Packer clinical composite score) or on ventricular remodeling parameters assessed by echography (Left ventricle end of systole volume). This rate has remained remarkably stable since the therapy started and has motivated many studies to better understand the underlying physiopathology and the CRT action mechanisms.

Among the various research axes to improve CRT response and responders rate, increasing the number of pacing sites in an attempt to better homogenize the cardiac mechanical activity has been evaluated. A configuration with two RV leads and one LV lead was tested acutely in three studies. In all cases, it demonstrated a significant improvement of cardiac performance whether assessed by echographic parameters or LV dp/dt measurements. Additionally feasibility of this approach for long term CRT delivery was demonstrated during a previous study. First results with triple-site ventricular stimulation are encouraging and its clinical efficacy should now be tested on a larger population in order to conclude on its interest for CRT candidates.

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
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

入选标准

  • Patient who signed the MEC approved informed consent
  • Patient older than 18
  • Patient with a CRT (CRT-P or D) indication as per ESC guidelines 2013
  • Left Ventricular Ejection Fraction (LVEF) ≤ 35%
  • NYHA class II/III/IV despite optimal medical treatment
  • Left Bundle Branch Block (LBBB) and QRS ≥ 120 ms (class IA and IB indications) or in the absence of LBBB QRS > 150 ms (class IIA indication)
  • De novo implantation
  • Sinus rhythm

排除标准

  • Permanent supra ventricular tachycardia
  • Pacing indication for 3rd degree AV block
  • Impossibility to perform FU at the investigative center
  • Pregnancy
  • Adults under legal protection
  • Heart transplant candidates
  • Concomitant pathology that may interfere with the study results

研究组 & 干预措施

Stimulation of 3 ventricular sites

Experimental

Cardiac resynchronization therapy implantation wil be done as usual, except the additional stimulation lead. Standard Echocardiography will be done at one year

干预措施: Cardiac resynchronization therapy implantation (Procedure)

Stimulation of 3 ventricular sites

Experimental

Cardiac resynchronization therapy implantation wil be done as usual, except the additional stimulation lead. Standard Echocardiography will be done at one year

干预措施: Stimulation of 3 ventricular sites (Device)

Stimulation of 3 ventricular sites

Experimental

Cardiac resynchronization therapy implantation wil be done as usual, except the additional stimulation lead. Standard Echocardiography will be done at one year

干预措施: Echocardiography (Device)

Stimulation of 2 ventricular sites

Active Comparator

Cardiac resynchronization therapy implantation wil be done as usual. Standard Echocardiography will be done at one year

干预措施: Cardiac resynchronization therapy implantation (Procedure)

Stimulation of 2 ventricular sites

Active Comparator

Cardiac resynchronization therapy implantation wil be done as usual. Standard Echocardiography will be done at one year

干预措施: Stimulation of 2 ventricular sites (Device)

Stimulation of 2 ventricular sites

Active Comparator

Cardiac resynchronization therapy implantation wil be done as usual. Standard Echocardiography will be done at one year

干预措施: Echocardiography (Device)

结局指标

主要结局

Difference from baseline in Left Ventricular End-Systolic Volume

时间窗: 12 months

Left Ventricular End-Systolic Volume will be evaluated using echocardiography

次要结局

  • Number of patients alive(12 months)
  • Difference from baseline in left ventricular remodelling(12 months)
  • Number of adverse events(12 months)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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