SMARTDELAY Determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,060
- 试验地点
- 1
- 主要终点
- Left Ventricular End-systolic Volume (LVESV)
研究概览
简要总结
The primary objective of SMART-AV is to assess the effect of SmartDelay for determining optimal AV delay timing during CRT compared to both a fixed AV delay and echocardiography-determined optimal AV timing chronically over a 6-month period.
详细描述
SMART-AV is a randomized, multi-center, double-blinded, non-significant risk, three-armed trial that will investigate the effects of optimizing AV delay timing in heart failure patients receiving CRT-D therapy. Patients will be randomized in a 1:1:1 ratio using randomly permuted blocks within each center. The study will compare chronic changes in structural and functional outcomes in CRT-D patients randomized to AV delay set as fixed, set with SmartDelay or determined by echocardiography. Patients will be followed at enrollment, implant, post-implant, 3-months post-implant and 6-months post-implant.
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
- Double (Participant, Outcomes Assessor)
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
- •Patients who meet current indications for a BSC CRT-D device with the SmartDelay algorithm
- •Patients who are willing and capable of undergoing a device implant and participating in all testing associated with the SMART-AV Study
- •Patients who are on optimal and stable pharmacologic therapy
- •Patients who are expected to be in sinus rhythm at the time of implant
- •Patients who have a life expectancy of more than 360 days, per physician's discretion
- •Patients who are geographically stable and willing to comply with the required follow-up schedule
- •Patients who are 18 years of age or above, or of legal age to give informed consent specific to state and national law
排除标准
- •Patients who are in complete heart block, or who otherwise are unable to tolerate pacing at VVI-40 RV for up to 14 days
- •Patients undergoing an upgrade of a pacemaker or implantable cardioverter-defibrillator who are unable to tolerate pacing at VVI-40 RV for up to 14 days
- •Patients who have previously received cardiac resynchronization therapy
- •Patients who are expected to receive a heart transplant or have other cardiac surgeries or procedures planned during the course of the study
- •Patients who currently have or who are likely to receive a tricuspid valve prosthesis
- •Patients who have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
- •Patients who are pregnant or planning to become pregnant during the study
- •Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
研究组 & 干预措施
Echo optimized AV delay
Echo optimized AV delay
干预措施: AV Delay programming through cardiac resynchronization therapy (Device)
Algorithm optimized AV delay
Algorithm optimized AV delay
干预措施: AV Delay programming through cardiac resynchronization therapy (Device)
Fixed AV Delay
Fixed AV Delay
干预措施: AV Delay programming through cardiac resynchronization therapy (Device)
结局指标
主要结局
Left Ventricular End-systolic Volume (LVESV)
时间窗: 6 months
Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up
次要结局
- Secondary Endpoints Will Include Structural and Functional Measures(Chronic)