CTRI/2014/08/004851进行中（未招募）不适用
Autonomic Neural Regulation Therapy To Enhance Myocardial Function In Patients With Heart Failure And Preserved Ejection Fraction (Anthem-HFpEF) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- LivaNova PLC
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- The primary safety endpoint will be the incidence of procedure and device-related adverse events.
研究概览
简要总结
Astudy to see the long- term effect of safety and efficacy of LivaNova VNSTherapy System for the treatment of symptomatic Diastolic heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients enrolled in the study must meet all of the following criteria:
- •Age 18 years or above
- •Willing and capable of providing informed consent
- •Capable of participating in all the testing associated with this clinical investigation
- •Chronic, symptomatic heart failure NYHA class II/III
- •On loop diuretic therapy for at least 1 month prior to enrollment
- •Left Ventricular Ejection Fraction (EF) ≥ 40%
- •Plasma NT-proBNP ≥ 220 pg/mL
- •Ratio of mitral velocity to early diastolic velocity of the mitral annulus (E/E’) > 15, or left atrial (LA) enlargement, defined as LA volume index ≥ 29 mL/m2
- •Controlled systolic blood pressure (systolic BP < 140 mmHg, or systolic BP between 140 and 160 mmHg receiving three or more blood pressure medications
- •Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 at screening (calculated by the modification of Diet in Renal Disease formula)
- •Symptoms limiting the duration of the 6-minute walk test must be due to heart failure alone.
排除标准
- •Exclusion Criteria: Patients who meet any of the following criteria are not eligible to be enrolled in the study:
- •Patients who have been hospitalized for heart failure and who required the use of HF IV therapy in the past 30 days
- •Patients with severe mitral (MR grade 4) or aortic valve disease
- •Patients whose heart failure is due to congenital heart disease
- •Patients with an alternative probable cause for the presenting symptoms, including but not limited to: a.
- •Isolated right heart failure due to pulmonary disease b.
- •Dyspnea and/or edema from non-cardiac causes, such as lung disease, anemia, or severe obesity c.
- •Hemodynamically significant mitral and/or aortic valve disease d.
- •Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
- •Patients with a previous documented LVEF < 40%
- •Ratio of mitral velocity to early diastolic velocity of mitral annulus (E/E’) < 8
- •Patients with serum potassium > 5.2 mmol/L
- •Patients with unstable angina, myocardial infarction, PTCA, cerebral vascular accident, or transient ischemic attack in the past 2 months
- •Patients with chronic atrial fibrillation (lasting more than 1 week or requiring cardioversion or pharmacologic conversion) in the past 2 months, or atrial fibrillation with a resting ventricular rate of > 120 bpm
- •Patients with severe pulmonary hypertension
- •Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or PCI) in the past 2 months or anticipated in the next 6 months
- •1st degree AV block with PR interval > 240 msec, 2nd or 3rd degree AV block
- •Patients with congenital or acquired long QT syndrome
- •Patients unable to tolerate anesthesia required for implant
- •Patients with documented recorded or suspected vasovagal syncope or vasodepressor syncope
- •Patients with a prior vagotomy
- •Patients with prior or existing vagal nerve stimulation treatment
- •Patients with locally implanted semi/permanent devices such as vascular catheters, etc.
- •Patients who are on an organ transplant list or expected to have an organ transplant within 6 months
- •Patients with a prior cardiac transplant
- •Patients with known or suspected vascular malformation in the carotid / vertebral circulatory bed
- •Patients who have existing or prior tracheotomy
- •Patients with severe vertebral cervical disease and limited mobility in the neck; includes those that frequently wear a brace
- •Patients who are likely to need an MRI of the neck area because of previous medical conditions
- •Patients with previous neck surgery and resultant scar formation that interferes with the ability to implant the study system
- •Patients actively treated for sleep apnea or sleep disordered breathing with therapies to maintain airway patency with or without oxygen supplementation
- •Patients with diabetes (type I or type II) that is being medically treated for autonomic or sensory neuropathy, or measured hemoglobin A1c (HbA1c) above 8.0% in the past 2 months
- •Patients with hypotension (systolic blood pressure < 80 mmHg)
- •Patient with active peptic ulcer disease or history of upper GI bleeding, or ulcer within 6 months
- •Patients with asthma, history of severe COPD (e.g., FEV1 < 1.5 L), severe restrictive lung disease, or oxygen dependence
- •Patients with known recurrent nerve paralysis
- •Patients who have undergone radiotherapy for thyroid disease/cancer
- •Patients who are likely to need shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy
- •Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
- •Patients with a life expectancy of less than 12 months per physician judgment
- •Patients involved in any concurrent clinical investigation or have undergone treatment by an investigational drug or device in the past 3 months.
结局指标
主要结局
The primary safety endpoint will be the incidence of procedure and device-related adverse events.
时间窗: 18-48 months
次要结局
- • Left atrial volume index(• 6-minute walk)
研究者
研究点 (10)
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