Fluoroless Conduction System Pacing Utilizing Electro-Anatomic Mapping Versus Conventional Implantation: The Fluoroless- CSP Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Success of achieving CSP
研究概览
简要总结
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.
详细描述
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.
In this study, we plan to randomize patients to fluoroscopy guided CSP vs 3D mapping guided CSP implants with low/zero fluoroscopy. The study with assess if 3D EAM guided implants can be performed successfully and without any significant increase in device implant related complications.
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
- Single (Participant)
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 years
- •Indication for Permanent Pacemaker implantation or implantation of Cardiac Resynchronization Therapy Device
排除标准
- •Existing cardiac device including Pacemaker or Cardiac Resynchronization Therapy device
- •Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
- •Pregnancy
- •Difficulty with follow-up
研究组 & 干预措施
Conventional Conduction System Pacing(CSP) using fluoroscopy
Subjects in this arm will receive Conduction System Pacing(CSP) using conventional fluoroscopy technique.
干预措施: Conventional fluoroscopy guided Conduction System Pacing(CSP) (Procedure)
Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system
Subjects in this arm will receive Conduction System Pacing(CSP) utilizing electroanatomic mapping system to eliminate or minimize fluoroscopic exposure.
干预措施: Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP) (Procedure)
结局指标
主要结局
Success of achieving CSP
时间窗: Intra-procedure
Feasibility of achieving a successful CSP implant at the His Bundle or Left Bundle branch with low or zero Fluoroscopy. This will result in low to no fluoroscopy exposure for both the subject and the operator, as well as shorter procedure times.This will be documented during procedure.
次要结局
- Procedure-related complications(30 days post procedure)
- Total radiation exposure time during procedure(Intra-procedure)
- Need for His Lead revisions(for a period of 6 months post procedure)