Does Targeted LV Lead Positioning Towards Latest Local Electric Activation at CRT Implantation Reduce Incidence of the Combined Endpoint "Death or Non-planned Hospitalisation for Heart Failure (HF)" in Patients With HF and Prolonged QRS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 10
- 主要终点
- Death or first non-planned hospitalisation for heart failure
研究概览
简要总结
Heart failure is a leading cause of morbidity and mortality. Cardiac resynchronization therapy (CRT) is a well-established treatment for patients with symptomatic heart failure in spite of optimised medical treatment (OMT), reduced left ventricular pump function with left ventricular ejection fraction (LVEF) ≤ 35% and prolonged activation of the ventricles (bundle branch block: BBB). CRT is established by implanting an advanced pacemaker system with three leads in the right atrium, right ventricle, and in the coronary sinus (CS) for pacing the left ventricle (LV), and often is combined with an implantable defibrillator (ICD) function. On average, CRT treatment improves longevity, quality of life and functional class, and reduces heart failure symptoms. Thus, at present, CRT is indicated for heart failure patients on OMT with BBB or chronic right ventricular (RV) pacing.
It is, however, a significant problem that 30-40% of CRT patients do not benefit measurably - showing symptomatic improvement or improved cardiac pump function - from this therapy (socalled non-responders). LV lead placement is one of the major determinants of beneficial effect from CRT.
Observational studies and three randomised trials with small sample sizes indicate that targeted placement of the LV lead towards a late activated segment of the LV may be associated with improved outcome. Based on this literature, some physicians already search for late activation when positioning the LV lead. However, such a strategy was never tested in a controlled trial with a sample size sufficient to investigate important clinical outcomes. Detailed mapping for a late activation may increase operating times and infection risk, result in use of more electrodes and wires, thereby increasing costs, and increase radiation exposure for patient and staff. Placement of the LV lead in late activated areas close to myocardial scar may even result in higher risk of arrhythmia and death.
At present, it is completely unsettled whether targeted positioning of the LV lead to the latest electrically activated area of LV is superior to contemporary standard CRT with regard to improving prognosis for patients with heart failure and BBB.
The present study aims to test whether targeting the placement of the LV lead towards the latest electrically activated segment in the coronary sinus branches improves outcome as compared with standard LV lead implant in a patient population with heart failure and CRT indication.
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)
盲法说明
Patients are unaware of treatment arm. All patients undergo the same pre-implant program and follow-up. Healthcare personel performing follow-up are blinded for treatment arm. Outcome events are evaluated by a committee blinded for treatment arm.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart Failure, NYHA II, III, outpatient IV
- •LVEF ≤35% measured by echocardiography
- •Optimal medical treatment for heart failure
- •Bundle Branch Block
- •Indication for primary CRT-D or CRT-P implantation or upgrade from RV pacing (pacemaker or ICD) to CRT-D or CRT-P
- •Ischemic heart disease (IHD) or non-IHD
- •Sinus rhythm or atrial fibrillation
- •Life expectancy >2 years
- •Signed informed consent
排除标准
- •NYHA class I
- •Acute mycardial infarction (AMI) within the latest 3 months
- •Coronary artery bypass graft (CABG) within the latest 3 months
- •Life expectancy <2 years
- •Participation in another clinical trial of experimental treatment
- •Contraindication for establishing implantable device treatment
- •Previously implanted CRT system
- •Does not wish to participate
研究组 & 干预措施
Control
Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator with the LV lead positioned preferentially in a posterolateral, non-apical position
干预措施: Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator (Device)
Intervention
Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator with the LV lead positioned according to the latest electrical activation in the CS
干预措施: Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator (Device)
结局指标
主要结局
Death or first non-planned hospitalisation for heart failure
时间窗: All patients will be followed until the last included patient has been followed for two years
Time to death or first non-planned hospitalisation for heart failure
次要结局
- Clinical response(Follow-up at 3, 6, 12, 24 and 48 months)
- Patient Reported Outcomes (PROs)(Follow-up at 6, 12, 24 and 48 months)
- Sudden death(All patients will be followed until the last included patient has been followed for two years)
- Persistent atrial fibrillation(All patients will be followed until the last included patient has been followed for two years)
- Fluoroscopy time(0-120 minutes, assessed at completion of implantation procedure)
- Equipment used at implantation(Assessed <24 hours after implantation initiation)
- Non-planned hospitalisation for heart failure(All patients will be followed until the last included patient has been followed for two years)
- Cardiac death(All patients will be followed until the last included patient has been followed for two years)
- Death(All patients will be followed until the last included patient has been followed for two years)
- Time to first appropriate ICD Therapy(All patients will be followed until the last included patient has been followed for two years)
- Battery longevity estimate(All patients will be followed until the last included patient has been followed for two years)
- Predictive value of P-wave(All patients will be followed until the last included patient has been followed for two years)
- Predictive value of QRS complex width(All patients will be followed until the last included patient has been followed for two years)
- Changes in cardiac chamber dimensions(All patients will be followed until the last included patient has been followed for two years)
- Changes in left ventricular ejection fraction LVEF(All patients will be followed until the last included patient has been followed for two years)
- Quality of Life (QoL)(Follow-up at 6, 12, 24 and 48 months)
- Echocardiographic measures of LV function(Follow-up at 6, 12, 24 and 48 months)
- Ventricular tachycardia (VT)/ventricular fibrillation (VF)(All patients will be followed until the last included patient has been followed for two years)
- Fluoroscopy dose(Assessed <24 hours after implantation initiation)
- Time to first inappropriate ICD Therapy(All patients will be followed until the last included patient has been followed for two years)
- Numbers of appropriate ICD Therapies(All patients will be followed until the last included patient has been followed for two years)
- Numbers of inappropriate ICD Therapies(All patients will be followed until the last included patient has been followed for two years)
- Any atrial fibrillation(All patients will be followed until the last included patient has been followed for two years)
- Implantation time(0-6 hours, assessed at completion of implantation procedure)
- Device-related outcomes(All patients will be followed until the last included patient has been followed for two years)
- Battery replacements(All patients will be followed until the last included patient has been followed for two years)
- QRS complex width(All patients will be followed until the last included patient has been followed for two years)
- QRS complex morphology(All patients will be followed until the last included patient has been followed for two years)
- Predictive value of QRS complex morphology(All patients will be followed until the last included patient has been followed for two years)
- Changes in right ventricular ejection fraction RVEF(All patients will be followed until the last included patient has been followed for two years)
研究者
Jens Cosedis Nielsen
Professor, DMSc, PhD, FESC, FEHRA
Aarhus University Hospital