Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Composite end-point: all-cause mortality, cardiac transplant, heart failure hospitalization, and left ventricular ejection fraction (LVEF) improvement <5 points.
研究概览
简要总结
Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS (CONSYST-CRT randomized clinical trial) is a non-inferiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant, heart failure hospitalizations, and left ventricular ejection fraction (LVEF) improvement <5 points.
详细描述
To date, studies have shown that conduction system pacing could get similar clinical and echocardiographic responses to those obtained with biventricular therapy.
This study will randomize 130 patients to a strategy of biventricular pacing versus conduction system pacing.
CONSYST-CRT study will analyze the following parameters in the 2 groups: left ventricular ejection fraction, ventricular volumes, echocardiographic response (>=15% decrease in left ventricular end-systolic volume), NYHA functional class, heart failure hospitalization, all-cause mortality, cardiac transplant, QRS shortening, echocardiographic asynchrony (septal flash).
Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year.
The first 70 patients have been recruited in the context of the LEVELAT study (ClinicalTrials.gov Identifier: NCT04054895)
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
- Single (Participant)
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
- •The patient must indicate their acceptance to participate in the study by signing an informed consent document.
- •The patient must be ≥ 18 years of age.
- •Left bundle branch block, QRS ≥130 and LVEF <=35%. No indication of stimulation for AV block.
- •Non-left bundle branch block, QRS ≥150 and LVEF <=35%.
- •Patients with indication of resynchronization therapy for ventricular dysfunction (LVEF <40%) and indication of cardiac pacing for AV block.
- •LVEF <=35% in NYHA class III or IV if they are in atrial fibrillation and have intrinsic QRS >=130 ms, provided a strategy to ensure biventricular capture is in place.
排除标准
- •Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
- •Pregnancy.
- •Participating currently in a clinical investigation that includes an active treatment.
结局指标
主要结局
Composite end-point: all-cause mortality, cardiac transplant, heart failure hospitalization, and left ventricular ejection fraction (LVEF) improvement <5 points.
时间窗: 12 months
Non inferiority margin 10%.
次要结局
- Change in left ventricular end-systolic volume.(6 months; 12 months)
- QRS shortening(Post-implantation (Electrophysiology Lab))
- Change in left ventricular ejection fraction.(6 months; 12 months)
- Echocardiographic response (>=15% decrease in left ventricular end-systolic volume).(6 months; 12 months)
- Hospitalization due to heart failure, mortality or cardiac transplant (combined endpoint)(6 months; 12 months)
- Change in NYHA functional class(6 months; 12 months)
- Correction of septal flash(15 days; 6 months; 12 months)
研究者
Josep Lluis Mont Girbau
Principal Investigator
Hospital Clinic of Barcelona