CTRI/2014/08/004851进行中（未招募）未知
Autonomic Neural Regulation Therapy To Enhance Myocardial Function In Patients With Heart Failure And Preserved Ejection Fraction (Anthem-HFpEF) Study - Anthem-HFpEF
ivaNova PLC0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients enrolled in the study must meet all of the following criteria:
- •1. Age 18 years or above
- •2. Willing and capable of providing informed consent
- •3. Capable of participating in all the testing associated with this clinical investigation
- •4. Chronic, symptomatic heart failure NYHA class II/III
- •5. Stable pharmacologic therapy for at least 1 month
- •6. On loop diuretic therapy for at least 1 month prior to enrollment
- •7. Left Ventricular Ejection Fraction (EF) >= 40%
- •8. Plasma NT-proBNP >= 220 pg/mL
- •9. Ratio of mitral velocity to early diastolic velocity of the mitral annulus (E/Eâ??) > 15, or left atrial (LA) enlargement, defined as LA volume index >= 29 mL/m2
- •10. Controlled systolic blood pressure (systolic BP < 140 mmHg, or systolic BP between 140 and 160 mmHg receiving three or more blood pressure medications
- •11. Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73m2 at screening (calculated by the modification of Diet in Renal Disease formula)
- •12. Physically capable and willing to perform repeated 6-minute walk tests associated with the study, and a baseline distance of between 150 and 425 meters. 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:
- •1. Patients who have been hospitalized for heart failure and who required the use of HF IV therapy in the past 30 days
- •2. Patients with severe mitral (MR grade 4) or aortic valve disease
- •3. Patients whose heart failure is due to congenital heart disease
- •4. 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. Hemodynamically significant obstructive lesions of the left ventricular outflow tract, including aortic stenosis
- •e. Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
- •5. Patients with a previous documented LVEF < 40%
- •6. Ratio of mitral velocity to early diastolic velocity of mitral annulus (E/Eâ??) < 8
- •7. Patients with serum potassium > 5.2 mmol/L
- •8. Patients with unstable angina, myocardial infarction, PTCA, cerebral vascular accident, or transient ischemic attack in the past 2 months
- •9. 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
- •10. Patients with severe pulmonary hypertension
- •11. 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
- •12. 1st degree AV block with PR interval > 240 msec, 2nd or 3rd degree AV block
- •13. Patients with congenital or acquired long QT syndrome
- •14. Patients unable to tolerate anesthesia required for implant
- •15. Patients with documented recorded or suspected vasovagal syncope or vasodepressor syncope
- •16. Patients with a prior vagotomy
- •17. Patients with prior or existing vagal nerve stimulation treatment
- •18. Patients with locally implanted semi/permanent devices such as vascular catheters, etc.
- •19. Patients with cardiac pacemakers, and pacemaker indicated patients
- •20. Patients who have a cardiac resynchronization therapy (CRT) device, or are scheduled for CRT in the next 6 months
- •21. Patients who are on an organ transplant list or expected to have an organ transplant within 6 months
- •22. Patients with a prior cardiac transplant
- •23. Patients with carotid murmur, vascular bruit, or significant carotid artery disease
- •24. Patients with known or suspected vascular malformation in the carotid / vertebral circulatory bed
- •25. Patients who have existing or prior tracheotomy
- •26. Patients with severe vertebral cervical disease and limited mobility in the neck; includes those that frequently wear a brace
- •27. Patients who are likely to need an MRI of the neck area because of previous medical conditions
- •28. Patients with previous neck surgery and resultant scar formation that interferes with the ability to implant the study system
- •29. Patients actively treated for sleep apnea or sleep disordered breathing with ther
研究者
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