ElectroCRT - Left Ventricular Lead Implant and Optimization Guided by Electrocardiography in Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Change in Left Ventricular Ejection Fraction (LVEF)
研究概览
简要总结
The purpose of this study is to investigate if "optimal electrical resynchronization" achieved by targeting left ventricular lead placement to the myocardial region with the latest electrical activation combined with post-implant pacemakersettings for narrowing the paced QRS width causes an excess improvement in the pumping function of the heart (the left ventricular ejection fraction) in Cardiac Resynchronization Therapy (CRT)
详细描述
Background:
Cardiac resynchronization therapy (CRT) is an established therapy in patients with a left ventricular (LV) ejection fraction (EF) < 35 %, and an electrocardiogram (ECG) with prolonged QRS duration (1). The treatment is implemented by implanting a pacemaker with three pacing leads: One in the right atrium, one in the right ventricle (RV) and one in an epicardial vein through the coronary sinus, thereby establishing atrial-synchronized biventricular pacing to coordinate RV and LV contraction.
Despite the convincing effect of CRT on survival, symptoms, and LV function (2,3,4) as much as 30-40 % of the patients do not benefit clinically from the treatment, so-called non-responders (5,6). Annually around 600 CRT-systems are implanted in Denmark and about 3000 patients live with a CRT. The risk of complications associated with CRT-treatment is considerable (7), and a conservative estimate of the expenses for implanting a CRT-device is DKK 80.000. Consequently, the costs of CRT in non-responders are high, both for the patients and for the health economy.
Potential correctable reasons for non-response to CRT are non-optimal LV lead positioning and non-optimal pacemaker programming (5). At the Department of Cardiology, Aarhus University Hospital, Skejby, the clinical practice is to place the LV lead in the non-apical postero-lateral region aiming towards a myocardial segment with electrical activation occurring in the second half of the QRS complex in the surface ECG.
Retrospective studies have documented an improved response rate to CRT when the LV lead is placed in a myocardial region with late electrical activation and without scar tissue (8,9). Furthermore, lack of electrical resynchronization after CRT illustrated by unchanged or prolonged QRS duration is associated with poor clinical outcome (10) and programming the interventricular (VV) delay to obtain the narrowest QRS-complex has been suggested to increase CRT response rate (11,12).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic heart failure (New York Heart Association (NYHA) functional class II - IV) despite optimal medical therapy
- •ECG with left bundle branch block and QRS ≥ 120 ms
- •LVEF ≤ 35 %
- •Age > 40 years
- •Written informed consent Patients with an indwelling single- or dual chamber pacemaker and a paced QRS > 180 ms are eligible for enrollment.
排除标准
- •Expected lifetime < 6 months
- •Expected heart-surgery within the next 6 months
- •Recent (< 3 months) myocardial infarction or coronary artery bypass graft (CABG)
- •Pregnant or lactating
- •No written informed consent Cardiac CT will not be performed in patients where this is contraindicated, i.e. in the presence of depressed renal function (estimated Glomerular Filtration Rate (eGFR) < 30 ml (milliters)/minute), thyrotoxicosis or in the case of former serious reactions to the contrast media.
研究组 & 干预措施
Optimal electrical resynchronization
Cardiac Resynchronization Therapy: LV lead implant according to electrical activation mapping of available epicardial veins to identify the latest electrical activated myocardial region. Post-implant interventricular (VV) electrical optimization for narrowing the paced QRS width. Post-implant standard pacemaker settings: Atrioventricular (AV) interval 100-130 ms and VV interval settings with simultaneous biventricular pacing.
Day 1 after implantation: ECG, AV-optimization guided by echocardiography, high-pitch cardiac CT to verify LV lead position.
Programming of the VV interval to obtain the narrowest QRS-width
干预措施: Cardiac Resynchronization Therapy (St. Jude Qaudripolar LV lead) (Device)
Routine CRT-strategy, imaging guided
Cardiac Resynchronization Therapy: LV lead implant guided by echocardiography and Rb-PET towards the latest mechanically activated myocardial segment and separate from scar. Post-implant VV electrical optimization for narrowing the paced QRS width. Standard pacemaker settings for both groups: AV-interval 100-130 ms and VV-interval settings with simultaneous biventricular pacing.
Day 1 after implantation: ECG, AV-optimization guided by echocardiography, high-pitch cardiac CT to verify LV lead position.
Continue standard interventricular pacing interval settings with simultaneous pacing in both ventricular leads.
干预措施: Cardiac Resynchronization Therapy (St. Jude Qaudripolar LV lead) (Device)
结局指标
主要结局
Change in Left Ventricular Ejection Fraction (LVEF)
时间窗: The day before implantation and 6 months after implantation
Change in LVEF determined by 2D echocardiography
次要结局
- Changes in Six Minutes Walk Test(The day before implantation and 6 months)
- Procedural radiation exposure(The day of implantation)
- Clinical response to CRT at 6 months follow-up if the patient is: 1. Alive, and 2. Not hospitalized for heart failure, and 3. experience an improvement of NYHA Functional Class or > 10 % increase in 6MWT(At the 6 months follow-up.)
- All cause mortality(6 months and until "3 years and 6 months" after implantation)
- Hospitalization for heart failure(6 months and until "3 years and 6 months" after implantation)
- Perioperative and late complications(The day of implantation, 6 months and until "3 years and 6 months" after implantation)
- Changes in Left Ventricular End Systolic Volume(The day before implantation and 6 months)
- CRT-implant procedure time(The day of implantation)
- Changes in Quality of Life(The day before implantation and 6 months)
- Changes in New York Heart Association Functional Class(The day before implantation and 6 months)
- Changes in level of N-terminal prohormone of brain natriuretic peptide(The day before implantation and 6 months)
- Changes in Left Ventricular End Diastolic Volume(The day before implantation and 6 months)
- Changes in Electrode Parameters (pacing threshold, sensing value, impedance)(The day after implantation and at 1 and 6 months follow-up)
- Changes in Echocardiographic Dyssynchrony parameters(The day before implantation and at 6 months follow-up)