跳至主要内容
临床试验/NCT06342492
NCT06342492招募中不适用

Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure

Kansas City Heart Rhythm Research Foundation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月7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
100
试验地点
1
主要终点
Need for lead revision

研究概览

简要总结

This a single-center, retrospective, observational study of patients that undergo coronary sinus(CS) lead revision, comparing epicardial lead placement to coronary sinus pacing(CSP) in those that had lead failure.

详细描述

Cardiac resynchronization therapy with defibrillator(CRT-D) improves quality of life, functionality, and even mortality for select patients with severe heart failure with reduced ejection fraction (HFrEF). It traditionally consists of three leads placed endovascularly into the right atrium, right ventricle, and left ventricle (LV) [typically placed into the CS], known as biventricular pacing resynchronization (BVP-CRT), respectively, from which electrical stimulation enables improved cardiac synchrony. Nonetheless, the placement of a CRT-D is not without risks. Lead-related complication is high and CRT-D implantation fails in up to 30% of patients due to lead placement alone.

Epicardial lead placement and CSP have been deemed viable alternatives to CRT-D. It has even been shown to be options in patients that fail conventional BVP-CRT. This is primarily due to increased accuracy, decreased complications, and even durability. However, guidelines for decision between a transthoracic approach and CSP is unclear, even more so after lead failure. Instead, this decision is currently individualized to the patient. There is a lack of prospective and head-to-head data between the two, and this study is aimed to compare transthoracic LV epicardial lead placement and CSP in patients with lead failure after BVP-CRT.

研究设计

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

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

  • All patients older than 18 years of age
  • Patients with HFrEF that underwent BVP-CRT
  • Experienced CS lead failure, whether initial or recurrent, subsequently replaced with transthoracic epicardial lead placement or CSP
  • Underwent Medtronic, Boston Scientific, or Abbott lead placement

排除标准

  • Patients younger than 18 years of age
  • Transthoracic epicardial lead placement or CSP performed as the initial approach or for other reasons than lead replacement
  • Those for which CRT no longer provides symptom relief or mortality benefit.

结局指标

主要结局

Need for lead revision

时间窗: Procedure Day

Compare the need for lead revision between conduction system pacing (CSP) and transthoracic left ventricular (LV) epicardial pacing approach

次要结局

  • Electrocardiography characteristics - QRS Interval(Procedure Day)

研究者

发起方
Kansas City Heart Rhythm Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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