跳至主要内容
临床试验/NCT04416958
NCT04416958招募中不适用

Pacing for Cardiac Resynchronisation Using the Intrinsic Conduction System to Maintain Physiologic Ventricular Activation

Klinikum-Fuerth1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
CIED Implantation success

研究概览

简要总结

Right ventricular pacing causes ventricular dyssynchrony and may be associated with impaired outcome. In the last decade, several approaches for more physiological pacing became available and were implemented in the latest guidelines. However, compared to conventional device implantation, cardiac resynchronization, His bundle pacing and left bundle area pacing remain demanding procedures in the individual case. Goal of the single center observational "Pace conduct" study is to evaluate implantation success, safety and outcome of pacing methods that maintain physiologic ventricular activation.

详细描述

Background:

Conventional ectopic myocardial right ventricular pacing (RVP) causes ventricular dyssynchrony and may be associated with reverse ventricular remodeling, reduced ejection fraction (EF), left ventricular dilatation, functional mitral valve regurgitation, heart failure and an increased rate of new onset atrial fibrillation.

Dependent on individual patient's characteristics, several strategies are established to prevent and to overcome the potential drawbacks of chronic RVP. In general, unnecessary ectopic RVP should be avoided. For example, in patients with sinus node disease and intact atrioventricular (AV) conduction, atrial pacing, AV (search) hysteresis or AAI-DDD/ADI pacing may be used. In patients with impaired cardiac function and an expected higher percentage of RVP, pacing strategies for cardiac resynchronization are indicated. Conventional cardiac resynchronization therapy (CRT) uses an additional transvenous left ventricular lead for synchronous ventricular stimulation and was shown to shorten QRS duration and to reduce morbidity and mortality in patients with chronic heart failure, left bundle branch block (LBBB) and reduced EF. Due to the non-physiological left ventricular epicardial stimulation, however, conventional CRT is associated with 30% of non-responders and may even prolong ventricular activation in patients with narrower QRS complex. First described in 1968, His bundle pacing (HBP) has evolved to an increasingly used alternative for cardiac pacing. Currently, HBP is regarded the most physiologic approach for ventricular stimulation because it prevents ventricular dyssynchrony and its potential fatal long-term consequences by preserving normal electrical activation of the ventricles. Clinical benefit of HBP has been shown compared with conventional permanent RVP and CRT. Recent studies documented restoration of normal electrical and mechanical left ventricular synchrony for both selective and non-selective HBP. However, compared with conventional RVP the implantation procedure for HBP is much more demanding requiring exact placement of the pacing lead within the anatomically variable His bundle area. Alternatively, the correction of bundle branch conduction disorders has been demonstrated for left bundle branch area (LBBA) pacing. As a consequence, current guidelines recommend pacing methods that maintain physiologic ventricular activation in patients with atrioventricular block who have an indication for permanent pacing with a LVEF between 36% and 50% and are expected to require ventricular pacing more than 40% of the time (class IIa indication).

In summary, there is increasing evidence showing the benefits of the different strategies for physiologic pacing but the appropriate use of these approaches may be challenging in the individual case. Therefore, appropriate patient selection, implantation approaches, device programming and follow-up require further intensive evaluation.

Objective:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Pacemaker or ICD Implantation aiming to avoid pacing induced ventricular dyssynchrony according to current guidelines
  • age >= 18 years

排除标准

  • no informed consent for the procedure given
  • no follow-up data

结局指标

主要结局

CIED Implantation success

时间窗: peri-procedural

successful Pacemaker- or ICD implantation with effective pacing and acceptable pacing threshold in the targeted area

次要结局

  • pre-operative: Implantation related Patient characteristics(1 month post implantation)
  • intra-procedural: implant success related with procedural characteristics(peri-procedural)
  • peri-procedural: safety and radiation(peri-procedural)
  • follow-up: device function(one year)
  • follow-up: outcome(one year)

研究者

发起方
Klinikum-Fuerth
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验