Acute Optimization of Cardiac Resynchronization Therapy (CRT) Using Echocardiography and SonR
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Percent of responding patients
研究概览
简要总结
The purpose of this study is to correlate the three lead placement (wires that go to the heart) possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart.
详细描述
A cardiac resynchronization therapy defibrillator (CRT-D) is a device designed to automatically recognize and stop rapid, harmful heart beats and allow the heart to return to a safe, regular heart rhythm. The CRT-D device may help the heart pump more efficiently by improving the timing of different parts of the heart beat. A CRT-D device has three leads (wires that go to the heart). One lead is placed in one of the top chambers of the heart (right atrium), another lead is placed in the lower right chamber (right ventricle) and the third lead is placed along the side of the left ventricle. The top chambers are stimulated first, either by the natural heartbeat or by the CRT-D device if the heartbeat is too slow. Shortly after that, the bottom chambers are stimulated. By pacing the heart in this way, the doctor hopes to improve the timing of different components of the heart beat in order to improve the efficiency of the heart and to improve the patient's heart failure symptoms. The purpose of this study is to correlate the three lead placement possibilities and the responses from the patient's heart. This will be done with the help of an echocardiography and SonR signals, which is an external device that is capable of detecting sounds created by the heart.
Based on the CRT implant, special measurements will be made to optimize the placements of the device leads. Based on the success of those measurements and a patient's own response, the patient will be placed into one of three groups.
Group 1: Patients with no response
Patients with a successful response will be randomized to:
Group 2: Lead placement based on study measurements
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Must have been indicated for implantation or upgrade to a CRT-D system in the last 3 months
- •Indicated for CRT according to current guidelines
- •QRS Duration between 120 ms and 150 ms
- •Able and willing to provide consent and Authorization of Use of PHI
排除标准
- •Myocardial infarction or acute coronary syndrome deemed inappropriate for trial per the investigator within 90 days of implant
- •Planned, or recent heart surgery or revascularization within the last three months
- •Already enrolled in other study that precludes enrollment in this study per Principal Investigator
- •Known Pregnancy at the time of enrollment
- •Age less than 18 at the time of enrollment
- •Unable to comply with follow-up requirements
- •Chronic Atrial Fibrillation
- •Recent history of medical non-compliance as determined by the investigator
- •Unable or unwilling to provide consent and Authorization of Use of PHI
研究组 & 干预措施
Experimental 1
Patients who respond will have their leads placed based on study measurements.
干预措施: Experimental (Device)
Control
Leads will be placed using standard procedures.
干预措施: Control (Device)
Experimental 2
Patients who respond will have their leads placed based on standard lead placement.
干预措施: Experimental 2 (Device)
结局指标
主要结局
Percent of responding patients
时间窗: 6 months
Percent of patients who have a positive response to implantation of the CRT at 6 months post-implant.
次要结局
- Comparison of echocardiography and SonR signals(6 months)