Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Left Ventricular Reverse Remodelling
研究概览
简要总结
The research aims to compare the response of Cardiac Resynchronisation Therapy (CRT) using HF ECG guided or the conventional method of Q-LV measurement guided optimisation for left ventricular, pacing site.
详细描述
The study aims to demonstrate that left ventricular (LV) pacing site optimisation using high frequency (HF) ECG improves LV reverse remodeling response to Cardiac Resynchronization Therapy (CRT), compared with Q-LV (Q-wave on the surface ECG to LV Electrogram) measurement after 6 months of treatment.
Participants will be implanted with a Cardiac Resynchronisation Therapy device with either pacemaker or defibrillator function.
The study is a single-Centre, randomized, prospective trial. One hundred and eighty participants will be assigned to either the treatment (HF-ECG guided LV pacing site optimisation) or control (Q-LV guided LV pacing site optimisation) arm, employing a 1:1 randomization. The participants will be followed up for a period of 6 months.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines;
- •In sinus rhythm;
- •NYHA class II, III or IV
- •Have reviewed, signed and dated an informed consent.
排除标准
- •Previous implant with a pacemaker, an ICD or a CRT device. (except upgrade from single chamber ICD with a fully functional defibrillation lead) not under recall or surveillance);
- •Persistent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month;
- •Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
- •Incessant ventricular tachyarrhythmia;
- •Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Coronary Intervention (PCI) within the past 4 weeks;
- •Correctable valvular disease that is the primary cause of heart failure;
- •Indication for valve repair or replacement;
- •Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months);
- •On transplant waiting list;
- •Previous heart transplant;
- •Already included in another clinical study that could confound the results of this study;
- •Life expectancy less than 1 year;
- •Inability to understand the purpose of the study;
- •Unavailability for scheduled follow-up or refusal to cooperate;
- •Age of less than 18 years;
- •Pregnancy;
- •Drug addiction or abuse;
- •Under guardianship.
结局指标
主要结局
Left Ventricular Reverse Remodelling
时间窗: 6 months
Absolute difference in left ventricular end systolic volume greater than or equal to 10%
次要结局
- Reduction in QRS duration(6 months)
- Change in quality of life score(6 months)
- Change in left ventricular ejection fraction(6 months)
- Change in NYHA Class(6 months)