Registry That Aims to Understand the Definition Used and Treatment Options Utilized by Clinicials for CRT Non-responders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,529
- 试验地点
- 69
- 主要终点
- Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months
研究概览
简要总结
The intent of this registry is to understand comprehensive clinical care strategies for Cardiac Resynchronization Therapy (CRT) patients especially non-responders in real-world clinical practice.
详细描述
Patients who are implanted CRT devices will be enrolled in the study. Once implanted, all patients will be followed at every 3 months for the first 12 months from the implant. The responder/non-responder evaluation will occur at 6 months from the implant date. The criteria used for determining the response to CRT will be captured.
During the office follow-up visits, arrhythmic episode diagnoses, device data and stored electrogram will be collected. All clinical events such as hospitalization for heart failure (HF), all-cause hospitalizations, and all-cause death will also be collected. For patients who are non-responders to CRT, any re-optimization of the device, i.e., atrioventricular and ventricle-to-ventricle interval optimization, left ventricular (LV) lead repositioning and pacing vector reconfiguration as well as modified/new clinical therapies administered in an attempt to improve HF condition will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient willing and able to sign informed consent
- •Patients implanted with any market-approved St. Jude Medical CRT-D/P device with no prior LV lead placement
排除标准
- •Are likely to undergo heart transplantation within the next 12 months
- •Are less than 18 years of age
- •Are pregnant or planning to become pregnant during the duration of the study
- •Are currently participating in a clinical investigation that includes an active treatment arm
- •Have a life expectancy of less than 6 months
结局指标
主要结局
Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months
时间窗: Between 6 and 12 months
Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT
时间窗: 6 months
Number of subjects where sites used echocardiographic remodeling, clinical functional assessments, or clinical events to determine response status.
Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months
时间窗: Between 6 and 12 months
Improvement in NYHA Class determined by improvement by at least 1 class.
Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response
时间窗: 6 months
1. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. 2. Sites used their own clinical criteria (could include hospitalizations, functional assessments, etc.)
次要结局
未报告次要终点