Solutions to the Challenges of Conduction System Pacing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- A1: Success rates of conduction system lead implant (novel workflow vs conventional methods)
研究概览
简要总结
Conduction system pacing is a new way of stimulating the heart using pacemaker wires. Traditional pacemakers stimulate the heart muscle which causes disordered heart beats: the walls of the heart move at different times. This wears down the heart over time.
Conduction system pacemakers stimulate the heart's electrical system directly producing natural heart beats that are much less disordered. Unfortunately, these pacemakers can only be implanted by a small group of experts at specialised centres with specialist equipment. This study aims to allow conduction system pacemakers to be offered to any patient at any hospital by simplifying the process of inserting the pacemaker wires and the improving the pacemaker's ability to interpret electrical traces.
Firstly, the best locations in the heart for conduction system pacemaker wires using specialised electrical traces, MRI and ultrasound scans will be identified. Features that can be seen on X-ray to guide doctors to these locations will then be identified. Secondly, the investigators will collect electrical information from the pacemaker wires and additional electrical traces to develop an algorithm that can make the interpretation the electrical traces more accurate.
详细描述
Study A:
100 patients will be prospectively recruited. These patients will be further divided into a derivation and validation group. The derivation group will consist of the first fifty patients recruited (patients 1-50) and the validation group will consist the second fifty patients recruited (patients 51-100).
All 100 patients will have an indication for pacemaker insertion and will undergo a conduction system pacemaker implant.
The derivation group will undergo the research protocol which will include additional measurements from:
- Ultra-high frequency ECG. A non-invasive surface ECG that detects, isolates and amplifies high frequency components that are filtered out in conventional ECGs.
- Electro-anatomical mapping. In majority of participants, the invasive mapping catheter will be inserted from the same venous access point to collect detailed electrical and anatomical data. In a small subset of patients, activation maps of the left ventricle will be collected, where the access will be through the femoral artery in the groin.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a ventricular pacing indication: high grade atrioventricular block and symptomatic trifasicular, bifasicular block or left bundle branch block LBBB for cardiac resynchronisation therapy
- •Adults willing to take part (ages 18 - 100 years old)
- •Able to give consent.
排除标准
- •Unable to give consent
- •Children age < 18 years and adults > 100 years old
- •Pregnant patients As per standard of care, female patients of child-bearing age will have a urine pregnancy test prior to their procedure.
结局指标
主要结局
A1: Success rates of conduction system lead implant (novel workflow vs conventional methods)
时间窗: From enrollment until 6 months after recruitment of last patient
B1: The number of patients with morphology change seen during decrementing output threshold test of 2-lead ECG when compared to gold standard 12-lead ECG
时间窗: From enrollment until 6 months after recruitment of last patient
次要结局
- A2: Procedure and fluoroscopy times of the streamlined workflow to current conventional methods of His-bundle and Left-bundle pacing(From enrolment to until completion of PPM insertion of the last patient recruited into Study A (patient 100); average total of 3 years)
- A2: Procedure and fluoroscopy times of the streamlined workflow of conduction system implant to current right ventricular pacing(From enrolment to until completion of PPM insertion of the last patient recruited into Study A (patient 100); average total of 3 years)
- A2: Assess capture threshold of conduction system pacing from the optimised workflow to that of conventional methods of conduction system implantation(From enrollment until 6 months after recruitment of last patient)
- A2: Define left bundle area capture diagnostics and delineate differences between left ventricular septal pacing.(From enrollment until 6 months after recruitment of last patient)
- B2: Improvement in device battery life measured in days and months with novel device algorithm applied(From enrollment until 6 months after recruitment of last patient)