NCT05659680尚未招募不适用
Achieving Conduction System Activation With Leadless Left Ventricular Endocardial Pacing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Procedure/Device related complication rate
研究概览
简要总结
The goal of this prospective non-randomised study is to test the feasibility of leadless conduction system pacing using the WiSE-CRT device in patients with an indication for Cardiac Resynchronisation Therapy.
The main question[s] it aims to answer are:
- What is the safety profile of leadless conduction system pacing?
- What is the success rate of leadless conduction system pacing?
- What are the electrical and haemodynamic effects of leadless conduction system pacing.
Participants will undergo pre-procedural cardiac CT, and post-procedure electro-anatomical mapping and haemodynamic assessments.
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
- •Age over 18 years
- •Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.
- •Patients meeting European Society of Cardiology Criteria for Cardiac Resynchronization Therapy (CRT) with Class 1 or 2a recommendation:
- •Dyssynchronous Heart Failure: Left Ventricular Ejection Fraction (LVEF) ≤35%, QRS duration >150ms or >130ms in presence of left bundle branch block (LBBB). Also included here are patients with EF ≤35%, an existing pacing system and an RV pacing burden of >20%.
- •BLOCK HF population: Patients requiring pacing for atrioventricular (AV) block with an LVEF ≤50%
- •AV node ablation (AVNA) population: Patients planned for AVNA with EF ≤50%.
排除标准
- •Any contraindication to LV endocardial pacing.
- •LV thrombus
- •Contra-indication to heparin
- •Contra-indication to anti-platelet agents
- •Failure of acoustic window screening
- •Septal wall thickness <5mm (minimum required wall thickness at any target implant site)
- •Myocardial infarction within 40 days prior to enrolment.
- •Cardiac surgery or coronary revascularisation procedure within 3 months prior to enrolment or to be scheduled for such procedures within the following 7 months.
- •Participation in other studies with active treatment/investigational arm.
- •Pregnant or planning to become pregnant in the next 7 months.
结局指标
主要结局
Procedure/Device related complication rate
时间窗: 6 months
Number of procedure or device related complications
次要结局
- ECG outcome(6 months)
- Success rate(6 months)
- Clinical outcome(6 months)
- LV function(6 months)
- Biventricular activation time(6 weeks)
- Haemodynamic improvement(6 weeks)
研究者
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