RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease: the ITALIA Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,260
- 试验地点
- 27
- 主要终点
- Heart failure
研究概览
简要总结
Study objective is to assess whether stimulation of the conduction system reduces cardiac decompensation events in patient follow-up, and how applicable this is in clinical practice and also to determine the impact of the studied interventions in terms of quality of life and cost-effectiveness for the treatment of patients with atrioventricular block. 1260 adult patients who are candidates for pacemaker implantation for the treatment of atrioventricular conduction disease will be randomised to stimulation of the conduction system or to the conventional stimulation.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Adult patients with AV block in either sinus rhythm (SR) or permanent atrial tachycardia/atrial fibrillation (AT/AF), or with slow AV conduction during AT/AF, or undergoing AV node ablation + ventricular stimulation
- •male and female
- •acquired informed consent
排除标准
- •Class I indication to Implantable Cardioverter Defibrillator (ICD) or to Cardiac Resynchronization Therapy (CRT)
- •Ejection Fraction < 35%
- •Life expectancy < 2 years
- •Participation in another clinical trial which might impact on the study outcome
- •Pregnancy, except as "In the event of an ongoing pregnancy, the doctor and patient will jointly assess, on a case-by-case basis and in the best interests of the patient, whether to propose participation in the study (random assignment to one of the two stimulation techniques) or to proceed as per clinical practice (assignment to one of the two stimulation techniques by the doctor). A screening log file of all eligible patients will be recorded, detailing the reason/s for non-randomization."
研究组 & 干预措施
Conduction System Pacing (CSP)
CSP occurs at the left endocardic surface of the interventricular septum hence specifically designed delivery catheters are used to advance the ventricular lead across the septum until its left-sided edge, where the Left Bundle is located.
干预措施: Conduction System Pacing (CSP) (Procedure)
Conventional System Pacing/Right Ventricular (RV) Pacing
RV pacing delivered either at the RV apex or RV septum. RV pacing is delivered by single chamber or dual chamber pacemakers depending on patients' rhythm (sinus or AT/AF) according to well-established clinical practice as described in the EHRA recommendtions
干预措施: Right Ventricular (RV) Pacing (Procedure)
结局指标
主要结局
Heart failure
时间窗: 36 months after the PM implant
composite endponit of: number of HF events, HF hospitalizations and HF non-pharmacological interventions
次要结局
- number of HF events(36 months after the PM implant)
- HF hospitalizations(36 months after the PM implant)
- HF non-pharmacological interventions(36 months after the PM implant)