Nordic-CSP - a Randomized Nordic Study - Is Conduction System Pacing Superior Compared to Conventional BIV-CRT in Reducing the Death or Heart Failure-related Hospitalization in Patients With Heart Failure and Bundle Branch Block?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 5
- 主要终点
- Patients with a primary end-point
研究概览
简要总结
The NORDIC-CSP trial is an investigator-initiated, blinded, nordic RCT aimed at evaluating whether using direct pacing of the HIS bundle (HIS)-pacing or left bundle branch (LBB) pacing is superior to conventional biventricular pacing in reducing the incidence of the composite endpoint of death and non-planned HF hospitalization. The study will be conducted in the 4 CRT-centres in Denmark and 6-8 centres from countries Sweden, Norway and Finland.
详细描述
In this investigator-initiated, blinded, nordic RCT, we will investigate conduction system pacing (CSP) in heart failure (HF) patients. We hypothesized that Cardiac Resynchronization Therapy (CRT) by HIS-pacing or LBB-pacing is superior compared to conventional biventricular (BIV)-CRT in reducing the incidence of the composite endpoint (Death and HF-hospitalization) in patients with symptomatic HF, with LVEF ≤ 35% and indication for CRT.
The Study is a collaboration between CRT centers in the Nordic countries with experience in CSP.
Randomization:
Randomization is conducted electronically using the CRF on the day of device implantation. A computer algorithm will randomly assign patients 1:1 to either the conventional method BIV-CRT or to "the new method" HIS/LBB-CRT.
Randomization will be stratified by the presence of a) true LBBB, b) other bundle branch block (BBB) and c) RV pacing. This will be performed by randomizing in blocks of 10 for LBBB and RV pacing/other bundle branch blocks. Block-randomization is used to ensure that each center includes a similar number of patients for each treatment arm.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age,
- •LVEF ≤ 35%,
- •NYHA Class II-IV (IV only outpatients),
- •optimized in medical treatment (OMT)
- •AND one of the following:
- •. LBBB according to AHA/ACC/HRS Scientific Statement from 2009 and ≥130ms or
- •LBBB-like intraventricular conduction delay (IVCD) > 150ms or RV paced QRS and indication for upgrade to CRT (> 40% RV pacing) OR
- •≥18 years of age,
- •LVEF ≤ 40 %
- •pacing indicated by AV-block and, thus, expected large percentage of ventricular pacing.
排除标准
- •recent acute myocardial infarction (AMI)
- •coronary artery bypass graft (CABG) (<3 months)
- •life expectancy <2 years, patients in hemodialysis
- •treatment with a cardiac implantable electronic device (CIED) is contraindicated.
- •Patients are excluded with regards to the MRI sub study if eGFR > 35 ml/min, in case or contrast allergy or certain metal implants.
结局指标
主要结局
Patients with a primary end-point
时间窗: From enrollment and a minimum of 2 years or the primary outcome has occurred
The primary endpoint is a composite of time to death or first non-planned HF hospitalization. Non-planned HF is defined as an unplanned emergency room visit or admission to hospital due to worsening HF
次要结局
- Change in Dyssynchrony(evaluated at baseline, 6 months, 24 months)
- Patients experiencing device-related complications(From baseline until study completion, with a minimum of 2 years.)
- Death(From baseline until study completion, with a minimum of 2 years)
- Non planned HF-hospitalization(From baseline until study completion with a minimum of 2 years)
- Echocardiographic remodelling(From baseline to 6 months and 24 months)
- Improvement in Clinical response(from baseline to 12 months)
- Improvement in Six-min walking test.(From baseline to 6 months)
- Neurohormones(from baseline to 6 months)
- Symptomatic response(From baseline to 6 months)
- Life quality(from baseline to follow-up at 12 months)
- ICD therapy(from baseline to study completion, with a mnimum of 2 years)
- Ventricular arrythmia(from baseline to completion of the study, with a mnimum of 2 years)
- atrial fibrillation(from baseline to completion of the study with a minimum of 2 years)
- time for implantation(at implantation, from 30 minutes to 300 minutes)
- x-ray(at implantation, from 1 minute to 150 minutes)
- Electrodes(form implantation to completion of the study, a minimum of 2 years)
- battery longevity(from implantation to completion of the study, with a minimum of 2 years)
研究者
Niels Risum
Md, PhD, Consultant cardiologist and electrophsiologist,
Rigshospitalet, Denmark