Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- ECM assessment
研究概览
简要总结
Purpose of the observational study is to assess the capability of a satellite tele-echocardiography (STE) system to acquire and transmit echocardiographic images and clips to an echocardiographic core laboratory (ECL) in a real time mode without loss of quality. Additionally the prognostic efficacy of specific echo parameters in the cardiac resynchronization therapy response will be evaluated.
详细描述
CORELAB-CRT is a prospective multi center Italian observational study. All echo images and clips will be transmitted by using an integrated satellite transmission system. All echo assessments performed in accordance to the centers clinical practice will be also used to investigate the prognostic efficacy of echo parameters in term of response to the cardiac resynchronization therapy (CRT). All commercially available multi-chamber CRT-D devices from any manufacturers are allowed in this observational study.
Any compatible market released right atrial, right ventricular and left ventricular lead from any manufacturer is allowed.
The echocardiography device models used to perform echo imaging for all patients participating in this analysis are GE Vivid 7, GE Vivid 9 and GE Vivid I, according to the model used in the clinical practice of the hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •NYHA class II, III and ambulatory IV with:
- •QRS complex duration ≥120msec;
- •Ejection fraction ≤35%.
- •Optimized medical treatment;
- •Patient in sinus rhythm;
- •Patient is willing and able to sign an informed consent form.
排除标准
- •Unstable angina, or acute myocardial infarction, coronary-aortic bypass graft or percutaneous transluminal coronary angioplasty within the past 3 months;
- •Cerebral vascular attacks or transient ischemic attack within the last month;
- •Chronic atrial arrhythmias, paroxysmal atrial fibrillation events;
- •Patients already implanted with an ICD or a CRT device;
- •Pacemaker dependency or ventricular pacing percentage ≥10%;
- •Valvular disease with an indication for surgical correction ≤12 months survival expectancy;
- •Mechanical right ventricular valve;
- •Patient is enrolled in or intends to participate in another clinical trial that may have an impact on the study endpoints;
- •Pregnancy or breastfeeding;
- •Previous heart transplant;
- •Refusal of study informed consent;
- •Expected lack of compliance during follow-up;
- •Patient is less than 18 years of age;
- •Patient's life expectancy is less than 6 months in the opinion of physician.
结局指标
主要结局
ECM assessment
时间窗: 6 months
Agreement in the echocardiographic measurement capability (EMC) between transmitted and echocardiographic device image on the set of high quality images transmitted by STE. Each echo image will be classified as high quality image if the Mean Opinion Score (MOS) will be greater than 3 points. For each high quality echo image (MOS greater or equal 3) the EMC will be assessed to both transmitted and device echocardiographic image.
次要结局
- Prognostic efficacy of specific echo parameters(6 months)
- Clinical composite score CCS(6 months)