NCT01112579已完成2 期
Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure
Medtronic Cardiac Rhythm and Heart Failure19 个研究点 分布在 8 个国家目标入组 81 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 19
- 主要终点
- Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.
研究概览
简要总结
The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.
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
- Single (Participant)
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
- •Left Ventricular Ejection Fraction (LVEF) of 35 percent or less
- •New York Heart Association (NYHA) functional Class III at time of screening
- •QRS duration less than 120 milliseconds (ms)
- •Left Ventricular End Diastolic Diameter (LVEDD) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months
- •Receiving stable optimal medical therapy for heart failure prior to enrollment
- •Serum creatinine less than or equal to 3.0 milligrams per deciliter (mg/dL)
- •18 years of age or older
- •Willing and able to comply with study procedures
- •Expected lifespan greater than 12 months beyond study enrollment as assessed by physician
排除标准
- •Interruption of thromboprophylaxis (e.g., heparin, LMWH, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician
- •Polyneuropathy
- •Requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
- •Unable to perform an exercise capacity test
- •Pregnant or planning to become pregnant during this study
- •Currently enrolled or plans to enroll in another investigational device or drug study that may confound the results of this study
- •Had Coronary Artery Bypass Graft/Percutaneous Coronary Intervention/Bare Metal Stent (CABG/PCI/BMS) procedures within the past 90 days
- •Had a heart transplant
- •Has complete heart block
- •Had Acute Coronary Syndrome within the past 90 days
- •Has congenital heart disease with significant hemodynamic shunting
- •Has chemotherapy-induced heart failure
- •Has reversible cardiomyopathy
- •Has severe mitral regurgitation (greater than 60 percent regurgitant fraction or greater than 0.3 centimeters squared (cm2) regurgitant orifice area)
- •Has diagnosed unstable angina pectoris
- •Has unstable coronary artery disease
- •Has a Cardiac Resynchronization Therapy (CRT) device implanted and is receiving CRT therapy
- •Has a non-Medtronic Implantable Cardioverter Defibrillator (ICD), pacemaker, or any non-transvenous defibrillation lead
- •Has a Medtronic ICD whose sensing threshold cannot be programmed to 0.3mV or greater
- •Has an existing neurostimulator
结局指标
主要结局
Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.
时间窗: Baseline and 6 months
次要结局
- Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months(Baseline and 6 Months)
- Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months(Baseline and 6 Months)
研究者
研究点 (19)
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