Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Successful HB pacing sites
研究概览
简要总结
This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and activation time of local intracardiac electrogram (IEGM) with an electro-anatomical mapping system during a device implant procedure and secondarily to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of electrical dyssynchrony in heart failure patients with left bundle branch block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Patients are undergoing implant of an Abbott pacemaker or CRT device under standard indications
- •An ECG with a wide QRS complex (>130 ms)
- •ECG morphology of typical complete LBBB,
- •Patients have heart failure with NYHA Class II-IV symptoms,
- •LV EF <50%
- •At least 18 years old and not pregnant.
- •Must provide written informed consent prior to any clinical investigation related procedure.
- •Willing to comply with study evaluation requirements
- •Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days prior to the implant procedure per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.)
排除标准
- •Patients have non-specific intraventricular conduction delay or right bundle branch block
- •Previously implanted cardiac devices with three or more permanent leads
- •History of aortic valve repair or replacement
- •History of tricuspid valve replacement
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- •Recent (< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacemaker or CRT implant in the opinion of the investigator
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
研究组 & 干预措施
Mapping and Pacing the His Bundle
All patients will be in this arm. Mapping and Pacing the His Bundle will be performed.
干预措施: Mapping and Pacing the His Bundle (Procedure)
Mapping and Pacing the His Bundle
All patients will be in this arm. Mapping and Pacing the His Bundle will be performed.
干预措施: Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing (Procedure)
结局指标
主要结局
Successful HB pacing sites
时间窗: At device implant procedure
Collect 3D Locations and electrogram characteristics (morphology and activation time) at the sites where His Bundle (HB) pacing is associated with left bundle recruitment and corrects electrical dyssynchrony at HB pacing implant procedure.
次要结局
- Echocardiographic measurements of LV end-systolic volume(At three-month follow-up)
- Sensing amplitude of HB pacing lead(Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit)
- Ventricular activation during HB pacing(At device implant procedure)
- Capture threshold of HB pacing(Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit)
- Success rate of HB pacing(At device implant procedure)
- Echocardiographic measurements of LV ejection fraction(At three-month follow-up)
- Lead impedance of HB pacing lead(Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit)