Fluoroless Conduction System Implant
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- Successful conduction system lead implantation with a fluoroless implant protocol
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. These pacemakers can be challenging to insert with different heart shapes, sizes and scars. This can increase procedure times and time exposed to xray as pacemakers are inserted using x-rays to guide where the lead is implanted.
This study aims to allow conduction system pacemakers to be implanted without the use of normal xray (fluoroscopy).
The investigators will create an anatomical shell of the heart using special plastic (mapping) catheters that is inserted within the heart from the groin. The investigators will use a special heart scanning (echo) catheter to see how the pacemaker wire is inserted into the heart muscle. The investigators will use MRI to confirm that the information we collect is accurate. Using this information the investigators will create a protocol to implant a lead that does not require xray, using only the mapping catheter.
详细描述
A total of 75 patients will be recruited for the study
50 patients with a ventricular pacing indication (high grade atrioventricular block and symptomatic trifasicular or bifasicular block) for pacing will be recruited prospectively. The patients will be divided into two groups; 25 patients in the derivation cohort and 25 patients in the validation cohort. The derivation cohort will undergo a detailed research protocol to determine the optimised work flow and this will be applied prospectively to the validation cohort.
The success rates, procedure times, complication rates and fluoroscopy times will be assessed. The 25 patients undergoing conventional methods of conduction system pacing will be recruited as a control arm to compare these outcomes.
In summary, the 75 patients will be grouped as following; 25 patients in the derivation cohort, 25 patients in the validation cohort and 25 patients in the control arm.
Methodology
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
Successful conduction system lead implantation with a fluoroless implant protocol
时间窗: From time of first patient recruited to the last patient recruited in the in the derivation cohort, upto 52 weeks
The primary objective of this study is to develop a fluoroless implant protocol of conduction system leads using 3D electroanatomical mapping. Electroanatomical mapping will be used to understand the cardiac anatomy, removing the reliance on fluoroscopy to position the pacemaker lead. Successful conduction system lead implant rates will be assessed against a control arm utilising conventional fluoroscopic methods.
次要结局
- Change in complication rates(From time of first patient recruitment to the 1 year after last patient recruited)
- Change in fluoroscopy time(From time of first patient recruited to the time of last patient recruited in the validation cohort upto 52 weeks)