NL-OMON46909撤回不适用
A Prospective, Multicenter, Open Label, Single Arm, Study to Assess the Safety & Performance of the Harmony Aortic Stimulation System (HASS) for the Treatment of Heart Failure - ENDO-HF
ENOPACE BIOMEDICAL LTD.0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 10
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria
- •1. Subject at least 18 years of age but no more than 85 years old
- •2. Subject is a male or a postmenopausal female, or a female of childbearing age for whom pregnancy was excluded and who has accepted to use adequate contraception measures for the entire study duration
- •3. Subject is diagnosed as chronic heart failure NYHA class II-III
- •4. Subject is treated with diuretic(s) for heart failure *30 days prior to study entry
- •5. Subject has no other noncardiac disease that could account for his/her dyspnea
- •6. For a subject with left ventricular ejection fraction (LVEF) * 40% all of the following must be present:
- •a) Left atrial enlargement > 25 cm2;
- •b) LA volume index * 40ml/m2;
- •c) Left ventricular hypertrophy as documented by echocardiogram with LVEDVI < 97 mL/m2;
- •d) NT-proBNP > 300 pg/mL
- •7. For a subject with left ventricular ejection fraction (LVEF) < 40%, subject has an elevated NT-proBNP >300
- •8. Subject should be receiving optimal medical treatment with no change in treatment in the previous 3 months (90 days) from enrolment with the exception of diuretic dosage; Optimal drug therapy as per current ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure . Subject has an average heart rate between 60 and 110 b/min recorded in a 24-h Holter measurement.
- •9. Subject is capable to walk a distance of 150-550 m in 6 minutes hall walk test.
- •10. Subject is willing to and capable of providing informed consent
- •11. Subject is capable of participating in all testing associated with this clinical investigation
- •12. Subject can comply with catheterization lab standard of care procedures
排除标准
- •Exclusion Criteria
- •1. Subject has been hospitalized for heart failure, diabetes or COPD within 30 days prior to enrolment
- •2. For a subject with left ventricular ejection fraction (LVEF) * 40%, the presence of chronic pulmonary disease requiring home oxygen therapy, oral steroid therapy, or hospitalization for exacerbation within 12 months of study entry, or significant chronic pulmonary disease in the opinion of the investigator
- •3. Subject with unstable angina, myocardial infarction, PTCA or coronary artery bypass graft within 180 days prior to enrolment
- •4. Subject with cerebral vascular accident or transient ischemic attack within 180 days prior to enrolment
- •5. Subject has resistant hypertension with systolic blood pressure * 180 mmHg within 30 days prior to enrolment
- •6. Subject has severe sclerosis or calcification of the thoracic aorta, as seen in CT scan
- •7. Subject has thoracic aorta abnormalities or disease e.g. aneurysm, dissection, extensive plaque, or implanted stent or stent graft, as seen in CT scan
- •8. Subject's anatomy is not compatible with the Harmony System, including that the aorta does not meet the appropriate anatomy (size and morphology) for implant placement based on Computed Tomography (CT) analysis.
- •9. Subject who has thoracic anatomy that does not enable adequate communication between implant and external unit as calculated by analyzing the CT scan, shall be excluded.
- •10. Subject diagnosed with severe aortic valve disease (severe aortic stenosis or aortic regurgitation)
- •11. Subject has severe mitral stenosis or grade 4 mitral regurgitation
- •12. Subject expected to undergo cardiac surgery during the study period
- •13. Subject whose heart failure is due to congenital heart disease
- •14. Subject diagnosed with Marfan Syndrome
- •15. Subject with moderate or severe chronic obstructive lung disease
- •16. Subject with renal insufficiency (eGFR<35)
- •17. Subject is allergic to iodine or contrast media
- •18. Subject is unable to take anticoagulants or antiplatelet agents
- •19. Subject has a 1st degree AV block with PR interval > 240msec, 2nd or 3rd degree AV block
- •20. Subject has history of brady-tachy arrhythmias
- •21. Subject with prior cardiac transplant or heart transplant candidate
- •22. Subject has infiltrative or restrictive cardiomyopathy
- •23. Subject had a vagotomy procedure in the past
- •24. Subject has a Body Mass Index (BMI) > 40 kg/m2
- •25. Subject with a life expectancy of less than 12 months, per physician judgment
- •26. Subject is a candidate within the 6 month follow up period for, or already has, a CRT and/or permanent pacemaker and is 100% pacemaker dependent
- •27. Subject who has an implantable cardioverter defibrillator that is affected by the Harmony System operation based on compatibility assessment during screening
- •28. Subject using any other medical electrical device
- •29. Subject involved in any concurrent clinical investigation
- •30. Subject has diseases or conditions which, in the judgment of the investigator, preclude participation in the clinical investigation
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