Electrically Guided Bachmann's Bundle Pacing Pilot Study: A Novel Lead Placement Strategy With Potential Antiarrhythmic Benefits
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Atrial arrhythmia burden from pacemaker counters
研究概览
简要总结
Despite identification of optimal ventricular pacing sites, which not only avoid dyssynchronous activation but can restore ventricular synchrony, optimal atrial pacing sites have not yet been identified. Specialized conduction tracts do not exist in the atria as they do in the ventricle. Activating the atria in a manner that preserves or improves interatrial synchrony may provide clinical benefit based on recent data. Prior site-selective right atrial septal pacing (RAS) pacing studies relied on non-specific fluoroscopic guidance during lead placement. These studies were limited by the lack of an electrogram target and electrical measures of successful atrial resynchronization. The goal of this study is to prospectively evaluate Bachmann's bundle lead placement guided by fluoroscopy and electrical markers (an endocardial electrogram target and paced P-wave criteria) and determine its anti-arrhythmic efficacy compared with right atrial appendage (RAA) pacing. Patients presenting for pacemaker placement with an indication for an atrial lead are randomized to either electrically-guided BB lead placement or RAA lead placement and then followed for 15 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Subject is >18 years old
- •Subject is referred for permanent pacemaker implantation with an indication for an atrial lead
- •Subject has either paroxysmal atrial fibrillation or baseline intra-atrial conduction delay (P-wave duration >120ms on a 12-lead ECG)
- •Subject is expected to remain available for standard-of-care pacemaker follow-up visits and study questionnaires
排除标准
- •Subject has permanent atrial fibrillation or is in atrial fibrillation in the pre-operative area prior to the procedure (inability to assess paced P-wave morphology)
- •Subject has pacemaker implantation prior to planned atrioventricular nodal ablation
- •Subject has resting spontaneous sinus rate >85 beats-per-minute
- •Subject has left ventricular ejection fraction <45%
- •Subject is unable or unwilling to complete baseline or follow up quality of life questionnaires
- •Subject is currently enrolled in a potentially confounding trial
- •Subject is pregnant
- •Subject's anticipated life expectancy is less than 1 year
研究组 & 干预措施
Bachmann's bundle area pacing
Lead placement in Bachmann's bundle area
干预措施: Bachmann's bundle lead placement (Procedure)
Right atrial appendage pacing
Lead placement in the right atrial appendage
干预措施: Right atrial appendage lead placement (Procedure)
结局指标
主要结局
Atrial arrhythmia burden from pacemaker counters
时间窗: Over 15 month follow up
Derived from pacemaker counters and expressed as the average percentage of time per day in atrial fibrillation/tachycardia.
次要结局
- Atrial lead fluoroscopy time(At implant)
- Atrial lead complications(Over 15 month follow up)
- Hospitalization or urgent outpatient visit for atrial fibrillation(Within 15 months follow-up post pacemaker)
- Cerebrovascular accident(Within 15 months follow-up post pacemaker)
- Atrial lead capture threshold (Volts)(Over 15 month follow up)
- Atrial lead sensing threshold (millivolts)(Over 15 month follow up)
- Atrial lead impedance threshold (Ohms)(Over 15 month follow up)
- Hospitalization or urgent outpatient visit for heart failure(Within 15 months follow-up post pacemaker)
- Change in P-wave duration from sinus P-wave to paced P-wave in Bachmann's bundle and right atrial appendage lead groups(At implant)
- Atrial lead procedure time(At implant)
- Atrial Fibrillation Ablation(Within 15 months follow-up post pacemaker)
- Atrial Fibrillation Severity Scale Version 2.0(Over 15 month follow up)
- EQ-5D-3L survey (*EQ-5D-3L is the name of the instrument and is not an acronym)(Over 15 month follow up)
- New start or up-titration of medications for the primary diagnosis of atrial fibrillation(Within 15 months follow-up post pacemaker)
研究者
Margaret Infeld
Cardiac Electrophysiology Fellow
University of Vermont