Evaluation of a Novel Method of Non-surface Electrocardiographic Mapping in Predicting Clinical, Structural and Neurohormonal Responses in Patients Undergoing Cardiac Resynchronization Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Echocardiographic: signs of LV reverse remodelling
研究概览
简要总结
Cardiac resynchronization therapy (CRT) involves pacing the left and right side of the heart in order to improve the coordination of the contraction in patients with heart failure. Current selection criteria incorporate the severity of the symptoms, the mechanical function of the heart and the time it takes the electrical stimulation to spread over the left ventricle (as assessed on the standard 12 lead electrocardiogram-ECG). Unfortunately these criteria only seem to select approximately 70% of the patients who might respond to this invasive therapy. Body surface ECG mapping is a new technique that assesses the electrical activation of the heart in more detail than the standard ECG. This study aims to determine whether this new technology may aid current selection criteria in predicting response to CRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Age >18 years old
- •Fulfils established clinical criteria for CRT implantation (with or without a defibrillator)
- •NYHA Class III-IV Heart Failure (or NYHA II with NYHA III/IV symptoms in the preceding 12 months)
- •LVEF <35% (Calculated using echocardiography or Cardiac MR) at the time of implantation
- •QRS duration > 130ms
- •Optimal Tolerated Medical Therapy for Heart Failure
排除标准
- •Severe, life threatening non cardiac disease
- •Active malignant disease and recent (<5 years) malignant disease
- •Prior Heart Transplant
- •Recent history of unstable angina, acute coronary syndrome or myocardial infarction within three months of enrolment into the study
- •Pregnancy
- •Failure to participate in consent process
- •Atrial Fibrillation
- •Conventional pacemaker in situ
- •Heart Failure requiring constant intravenous therapy including diuretics and/or inotropes
- •Recent revascularisation procedure i.e. coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the last three months
研究组 & 干预措施
CRT Eligible
ACC/AHA/HRS/ESC guidelines for device-based therapy
干预措施: Body Surface ECG Mapping (Device)
CRT Eligible
ACC/AHA/HRS/ESC guidelines for device-based therapy
干预措施: CRT Implant (Device)
结局指标
主要结局
Echocardiographic: signs of LV reverse remodelling
时间窗: Baseline and 6 months
Increase by \>5% in left ventricular ejection fraction with an associated decrease in LV end-diastolic (LVEDV) and end-systolic (LVESV) volumes
Change in distance travelled during six-minute walk test (6MWT)
时间窗: Baseline and 6 months
次要结局
- Symptoms(Baseline and 6 months)
- Pacing(6 months)
- Neurohormonal status(Baseline and 6 Months)
研究者
Tom Jackson
Clinical Research Fellow
Guy's and St Thomas' NHS Foundation Trust