RESPONSE HF - Response of Cardiac Resynchronization Therapy Optimization With Interventricular (VV) Timing in Heart Failure Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 816
- 试验地点
- 2
- 主要终点
- CRT Responder Rate
研究概览
简要总结
The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.
For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:
- < 10% improvement in 6-minute hall walk, and
- no class improvement or worsening in New York Heart Association (NYHA) scale.
For those receiving CRT-D devices as replacements of older CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:
- > 1 heart failure (HF) related hospitalization, and
- no class improvement or worsening in NYHA scale.
详细描述
Study Methods
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This is a prospective, randomized (simultaneous biventricular (BiV) pacing vs. sequential BiV pacing) study.
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Any patient that receives an FDA approved St. Jude Medical (SJM) CRT-D with V-V timing is eligible for enrollment.
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At 3 months post enrollment (or at implant for CRT-D replacements), patients screened as non-responders are randomized to either simultaneous or sequential BiV pacing. Patients requiring a replacement CRT-D device that are identified as non-responders to CRT are enrolled at the screening/randomization visit.
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Patients are followed for a period of 6 months post randomization:
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Enrollment (1 week pre CRT-D implant to < 2 weeks post CRT-D implant)
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Screening/Randomization Visit (3 months post enrollment)
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Follow-up Visit (6 months post randomization)
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Total # of centers - 80 centers
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Sample size - 800 patients screened for CRT non-responders
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
- 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
- •Patient has a standard indication for a CRT-D.
- •Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
- •Patient is geographically stable and willing to comply with the required follow-up schedule.
- •Prior to 1 month of randomization, patient's HF medications are maintained stable and remain stable throughout the study.
- •Patients requiring a CRT-D replacement must comply with BOTH of the following:
- •> 1 HF related hospitalization
- •No class improvement or worsening in NYHA scale
排除标准
- •Patient's life expectancy is less than 12 months.
- •Patient has had cardiac surgery within 6 months of enrollment.
- •Patient has an epicardial ventricular lead system.
- •Patient is less than 18 years old.
- •Patient is pregnant.
结局指标
主要结局
CRT Responder Rate
时间窗: 6 months
Patients underwent baseline NYHA class and 6-minute hall walk distance (6-MHWD) assessment. After device implantation AV delays were optimized and all patients were programmed to simultaneous biventricular (BiV) pacing. At the 3-month follow-up, the NYHA class and 6-MHWD were reassessed. Non-responders were randomized 1:1 to either sequential BiV pacing with VV optimization or simultaneous BiV pacing. The responder rate at 6 months post randomization was compared between the two groups. Which is why the numbers are broken further down in the Outcome Measure table.
次要结局
- Left Ventricular Ejection Fraction (LVEF)(Randomization and 9 months)
- NYHA Class Progression(6 months)
- 6 Minute Hall Walk Distance Test (6-MHWD)(6 months)