Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- LBBAP ICD lead CRT efficacy
研究概览
简要总结
The recent development and market introduction of small diameter implantable defibrillation leads able to deliver left bundle branch area pacing (LBBAP) has opened the possibility of achieving cardiac resynchronization therapy (CRT) using a single- or dual-chamber implantable-cardioverter defibrillator (ICD). This approach may reduce the number of intracardiac leads required and, consequently, has the potential to lower both procedural and long-term complication rates. However, the integration of these leads into currently recommended CRT strategies remains hypothetical. The FORGE CSP registry will prospectively enroll patients with an indication for CRT in whom implantation of a LBBAP ICD lead is attempted.
详细描述
The FORGE CSP Registry is a prospective, multicentre and nationwide, post-approval registry, including consecutive patients with an indication for CRT and in whom implantation of a LBBAP ICD lead is attempted as a first line strategy.
The primary objective of this registry is to measure the proportion of patients who achieve effective CRT solely through the use of a LBBAP ICD lead (plus right atrial lead if appropriate).
The secondary objectives of this registry are: (1) to assess the feasibility of the LBBAP ICD lead implantation (regarding LBBAP validated electrophysiologic criteria) and the associated learning curve; (2) to evaluate the incidence of implantation of a third lead, namely a left ventricular lead positioned in the coronary sinus, in combination with the LBBAP ICD lead (LOT-CRT); (3) to assess the risk of complications related to the use of the LBBAP ICD lead, including its impact on tricuspid valve function, the risk of lead dislodgement, and other procedure- or device-related complications; (4) to evaluate de cost-effectiveness of CRT using LBBAP ICD lead, compared with conventional CRT; (5) and to compare CRT response in LBBAP ICD lead recipients, versus historical cohort of conventional CRT.
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
- 否
入选标准
- •age > 18-year-old
- •indication for CRT according to current ESC/EHRA guidelines
- •first-line LBBAP ICD lead implantation attempted
- •national insurance coverage
排除标准
- •pregnancy
结局指标
主要结局
LBBAP ICD lead CRT efficacy
时间窗: 0 - 3 Months
Proportion of patients with an effective CRT (defined by LBBAP validated ECG criteria) using solely the LBBAP ICD lead (plus right atrial lead if appropriate).
次要结局
- LBBAP ICD lead implantation feasibility(Procedural)
- LOT-CRT utilization(Procedural)
- Safety of LBBAP ICD lead(0 - 3 Months)
- Cost-effectiveness(Procedural)
研究者
Pierre OLLITRAULT
MD
University Hospital, Caen