Effect of Biventricular Upgrade on Left Ventricular Reverse Remodeling and Clinical Outcomes in Patient With Left Ventricular Dysfunction and Intermittent or Permanent Apical/Septal Right Ventricular Pacing (Budapest CRT Upgrade Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 33
- 主要终点
- A composite clinical and echocardiographic end point comprising the first occurrence of a non-fatal heart failure event, all-cause mortality, or < 15% reduction in echocardiography determined LVESV from baseline to 12-month.
研究概览
简要总结
Effect of biventricular upgrade on left ventricular reverse remodeling and clinical outcomes in patient in left ventricular dysfunction and intermittent or permanent apical/septal right ventricular pacing (Budapest CRT upgrade study)
详细描述
The aim of this study is to investigate the effect of upgrade to a CRT-D device on clinical and echocardiographic response at 12-month in patients with left ventricular dysfunction (LVEF ≤35%), symptomatic heart failure (NYHA II, III, IV-a), and intermittent or permanent right ventricular pacing with paced QRS complex ≥ 150 ms compared to continued therapy with a single or dual chamber pacemaker (PM) or ICD.
Prospective, post-market, international multicenter randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female patients over the age of 18 (expected survival time: over 1 year)
- •Patients with ischemic or non-ischemic cardiomyopathy;
- •Those implanted with a single or dual chamber ICD or implanted with a single or dual chamber pacemaker at least 6 months before inclusion;
- •Elective generator replacement or upgrade from pacemaker-only to ICD therapy may be indicated at the time of enrollment, but are not required;
- •Right ventricular pacing 20-100% in at least the last 90 days before enrollment (with an optimal AV interval based on the physician's discretion to avoid unnecessary right ventricular stimulation);
- •Symptomatic heart failure for at least 3 months before inclusion;
- •NYHA functional class II or III, or IV a;
- •Left ventricular ejection fraction measured by echocardiography ≤ 35%;
- •Paced QRS complex ≥ 150 ms;
- •Optimal heart failure medical therapy;
- •Informed consent obtained.
排除标准
- •Intrinsic QRS with LBBB morphology (measured at VVI 40 bpm setting as per protocol);
- •CABG or PCI in the past 3 months;
- •Acute myocardial infarction in the past 3 months;
- •Unstable angina;
- •Planned coronary revascularization (PCI or CABG);
- •Planned cardiac transplantation;
- •Acute myocarditis;
- •Infiltrative myocardial disease;
- •Hypertrophic cardiomyopathy;
- •Severe primary mitral and aortic valve stenosis or regurgitation;
- •Women who are pregnant or plan to become pregnant or breastfeeding;
- •Subjects who are unable or unwilling to cooperate with the study protocol;
- •Tricuspid valve prosthesis;
- •Any serious disease likely to interfere with the conduct of the study;
- •Participation in other clinical trial;
- •Patients geographically not stable or unavailable for follow-up;
- •Chronic, severe renal dysfunction (creatinine value > 200 μmol/l);
- •Severe RV dilatation (RV basal diameter >50mm);
- •Severe tricuspid insufficiency.
结局指标
主要结局
A composite clinical and echocardiographic end point comprising the first occurrence of a non-fatal heart failure event, all-cause mortality, or < 15% reduction in echocardiography determined LVESV from baseline to 12-month.
时间窗: 12 months
次要结局
未报告次要终点