VisONE Pilot Study of Chronic Asymptomatic Diaphragmatic Stimulation for Patients With Symptomatic Heart Failure, Reduced Ejection Fraction and Preserved Ventricular Synchrony
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Freedom from serious complications or adverse events during procedural recovery and acute therapy
研究概览
简要总结
The VisONE HF pilot is a feasibility pilot for evaluating the benefits and risks of chronically delivering Asymptomatic Diaphragmatic Stimulation in medical refractory heart failure patients using the VisONE™ implantable system for 12 months.
详细描述
This 12 month study is intended to validate the early benefits observed with Asymptomatic Diaphragmatic Stimulation (ADS) as a primary form of heart failure therapy with low rates and severity of adverse effects. Medical refractory symptomatic heart failure patients with reduced ejection fraction and no evidence of arrhythmias or ventricular dysynchrony will undergo laparoscopic implantation of the VisONE™ implantable system comprised of a pulse generator and two leads, programmed to deliver cardiac-gaited diaphragmatic stimulation pulses at asymptomatic outputs. Patients will be followed in pre-specified durations of 1,3,6 and 12-months using a series of evaluations of hemodynamic, echocardiographic, heart failure status, diaphragmatic function, implanted system data and standard safety measures including adverse events, for comparison with their baseline values. The results are intended to be used for designing a subsequent larger study for performing statistical power calculations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Independent data review and analysis by the University of Glasgow Department of Biostatistics
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
- •NYHA class II/III medical refractory despite guideline indicated heart failure medications
- •Sinus rhythm with <10% ectopy
- •NT-proBNP > 500 (250 if on loop diuretics)
排除标准
- •6MHW >500 m or < 200 m
- •Resting HR > 140 bpm
- •SBP <80 mmHg or > 170 mmHg
- •Serum creatine > 2.5 mg/dL
- •Ventricular dyssynchrony by ECG with QRS ≥ 140ms
- •Unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF, NSVT, sustained VT or VF, or DCCV within 3 months
- •Intermittent inotropic drug treatment
- •Existing pacemaker or indications for a pacemaker
- •Severe primary pulmonary disease including pulmonary arterial hypertension or severe COPD, or other respiratory or lung diseases where FEV < 50% or any condition with severe diaphragmatic dysfunction
- •Previous open laparotomy within 1 year or contraindications to laparoscopy, as determined by implanting physician
- •Known or active intra-abdominal infections, or known intra-abdominal pathology
- •Previous thoracic or abdominal organ transplant, transplant waiting list
- •Pregnancy
研究组 & 干预措施
VisONE ADS
Patients implanted with a VisONE stimulator and leads for receiving continual Synchronized Diaphragmatic Stimulation
干预措施: VisONE ADS (Device)
结局指标
主要结局
Freedom from serious complications or adverse events during procedural recovery and acute therapy
时间窗: after 3 months of therapy
The following serious complications and adverse events will be analyzed for their rate and severity and compared to other implantable device systems * Excessive procedural or implanted system morbidity * Procedural or implanted system events resulting in unscheduled patient hospitalizations and surgical intervention * Incidences resulting in physician choice to permanently discontinue therapy
次要结局
- Freedom from complications or adverse events during chronic therapy(after 3 and 12 months of therapy)
- Freedom from serious complications or adverse events during chronic therapy(after 12 months of therapy)