Angiography and Electrogram Guided Bachmann Bundle Pacing - ANGEL BBP
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Success of Bachmann bundle pacing using angiography at implant
研究概览
简要总结
People eligible for this study are scheduled to have a permanent pacemaker (PPM) or defibrillator device (ICD) implanted as part of their routine care. This device will also have a wire placed in the right atrium (RA) of the heart. As an alternative to the RA, the wire can also be placed in the Bachmann bundle (BB).
This study is being done to compare two options to help place the wire in the Bachmann bundle. One option uses contrast dye and x-ray, and the other option uses electrocardiogram (ECG) and contrast dye and x-ray. We want to learn more about how well these options work in implanting the wire in the Bachmann bundle.
Both of these options are FDA approved and used in standard practice.
详细描述
The ANGEL BBP study is a prospective, single-center, randomized, controlled research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the feasibility and success rates of Angiography guided Bachmann bundle pacing (BBP) lead implantation compared to traditional approach.
Eligible patients would undergo BBP using Medtronic 3830 lead and C304 or C315 family of sheaths. BBP will be confirmed at implant using Bachmann bundle potentials recorded from the lead, ECG 'P' wave morphology and duration during atrial pacing, fluoroscopic locations on right anterior oblique (RAO) and left anterior oblique (LAO) projections.
During implant procedure, 5-10 ml of contrast will be used to perform inferior superior vena cava (SVC) angiogram via the lead delivery sheath in RAO and LAO views. The pacing lead will be then implanted using these images as guidance along with recording of local electrograms from the pacing lead.
The study team will randomize 50 patients who satisfy inclusion and exclusion criteria. The study team will compare the difference in procedural success between Angiography and Electrogram guided BBP and Electrogram/ECG only guided BBP patients.
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
- 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
- 是
入选标准
- •Patients > 18 years of age
- •Patient with an indication for permanent pacemaker or ICD utilizing atrial pacing lead
- •Patient is willing to comply with all study procedures and be available for the duration of the study.
排除标准
- •Inability to provide informed consent
- •Enrolled in a concurrent study that may confound the results of this study.
- •Persistent atrial fibrillation at the time of implant (if cardioversion contraindicated at the time of implant, where BB mapping cannot be performed in sinus rhythm)
- •Renal dysfunction with serum Creatinine >3.0 mg/dl
结局指标
主要结局
Success of Bachmann bundle pacing using angiography at implant
时间窗: Perioperative
Change in implant procedure duration
时间窗: Perioperative
Change in implant procedure duration between the two arms
次要结局
- Paced P-wave morphology compared to native P-waves(3 month follow up)
- Paced P-wave duration compared to native P-waves(3 month follow up)
- Atrial pacing parameters(3 month follow up)
研究者
Pugazhendhi Vijayaraman
Director, Cardiac Electrophysiology
Geisinger Clinic