NL-OMON51726已完成不适用
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
van de Wetering CRC0 个研究点目标入组 2 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
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject is at least 18 years old 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. Heart Failure is accompanied by:
- •For HFrEF Subjects (must meet at least one of the following):
- •* BMI-corrected NT-proBNP> 300pg/ml.
- •* BMI-corrected NT-proBNP*450 pg/ml if persistent atrial fibrillation is
- •For HFpEF subjects (must meet at least one of the following):
- •* BMI-corrected NT-proBNP> 300pg/ml.
- •* BMI-corrected NT-proBNP*450 pg/ml if persistent atrial fibrillation is
- •* PCW at rest >15 mmHg
- •* PCW at exercise > 25 mmHg
- •For BMI corrected NT-proBNP see appendix E
- •5. Subject should be on stable, maximally-tolerated, guideline-directed
- •cardiovascular medications for at least 30 days prior to enrolment.
- •6. Subject has an average heart rate between 60 and 110 b/min recorded in a
- •24-h Holter measurement.
- •7. Subject is capable to walk a distance of 150-450 m in 6 minutes hall walk
- •8. Subject is willing to and capable of providing informed consent.
- •9. Subject is capable of participating in all tasks associated with this
- •clinical investigation.
- •10. Subject can comply with catheterization lab standard of care procedures.
排除标准
- •1. Subject has a Cardiac Resynchronization Therapy (CRT) or is a candidate
- •within the next 6 months to have one
- •2. The subject has a permanent pacemaker and is 100% pacemaker dependent.
- •3. Subject has an Implantable Cardioverter Defibrillator (ICD) and/or any other
- •active electrical implant that is found to be affected by the Harmony System
- •operation in a compatibility assessment performance.
- •4. Subject has significant uncontrolled symptomatic bradyarrhythmias or
- •unstable ventricular arrhythmias.
- •5. Subject has a 1st degree AV block with PR interval > 240msec, 2nd or 3rd
- •degree AV block.
- •6. Subject has severe Chronic Obstructive Pulmonary Disease (COPD) or severe
- •restrictive lung disease (e.g., requires chronic steroid use or home oxygen use)
- •7. Subject has a Body Mass Index (BMI) * 40 kg/m2
- •8. Subject with renal insufficiency (eGFR<25 ml/min/1.73 m2)
- •9. Subject has thoracic aorta*s abnormalities or diseases (e.g. aneurysm,
- •dissection, extensive plaque, implanted stent or stent graft)
- •10. Subject's thoracic aorta*s anatomy is not compatible with the Harmony*s
- •implant (e.g. aortic diameter or morphology) based on CT scan analysis.
- •11. Subject*s thorax anatomy does not enable adequate communication between
- •implant and the external patient unit based on CT scan analysis.
- •12. Subject diagnosed with severe valvular (Mitral or Aortic) disease (e.g.
- •severe stenosis or regurgitation).
- •13. Subject with prior cardiac transplant or heart transplant candidate.
- •14. Subject with unstable angina, myocardial infarction, percutaneous
- •transluminal coronary angioplasty, cerebral vascular accident, transient
- •ischemic attack or coronary artery bypass graft within 90 days prior to
- •15. Subject expected to undergo cardiac surgery or percutaneous cardiac
- •intervention (e.g. coronary and valves) during the study period.
- •16. Subject whose heart failure is due to congenital heart disease.
- •17. Subject is unable to take anticoagulants or antiplatelet agents.
- •18. Subject has infiltrative or restrictive cardiomyopathy.
- •19. Subject diagnosed with Marfan syndrome.
- •20. Subject is allergic to iodine or contrast media.
- •21. Subject has diseases or conditions which, in the judgment of the PI,
- •preclude participation in the clinical investigation.
- •22. Subject with a life expectancy of less than 12 months, per PIs' decision.
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