NL-OMON39112已完成2 期
A Study of Percutaneous Left Ventricular Reshaping of Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve LV Function Using the Accucinch System. - LV Restore Study
Guided Delivery Systems, Inc.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
- 2 期
- 状态
- 已完成
- 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
- •1. Age >= 18 years
- •2. Subjects with clinically significant mitral regurgitation (MR 2+ and above)
- •3. Ejection Fraction >= 25%
- •4. Stable cardiac medical regimen for heart failure for at least 1 month
- •5. Stable NYHA Classification for at least 1 month
- •6. Subject is eligible for cardiac surgery
- •7. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written consent
排除标准
- •1. Myocardial infarction within 90 days of the intended treatment with the device
- •2. Prior surgical, transcatheter, or percutaneous mitral valve intervention
- •3. Any intervention for coronary artery disease (CAD) within the last 30 days prior to treatment, or unrevascularized multivessel coronary disease.
- •4. Hemodynamic instability or the need for emergent surgery
- •5. Non-ambulatory NYHA Class IV symptoms of heart failure or subjects requiring IV inotropic support
- •6. Subjects in whom sufficient quality of echocardiography (TTE and TEE) cannot be obtained
- •7. Echocardiography evidence of primary mitral valve disease causing MR or MS
- •8. Evidence of mitral valve stenosis with an estimated valve area less than 3.0 cm²
- •9. Mitral valve prosthesis or pathology that would prevent adequate function of the GDS Accucinch System
- •10. Estimated GFR of <30ml/min/1.73m²
- •11. Greater than mild mitral annular calcification observed by fluoroscopy
- •12. Presence of aortic valve prosthesis
- •13. Moderate to severe aortic valve stenosis or calcification observed by echocardiography or fluoroscopy
- •14. Severe aortic arch calcification or mobile aortic atheroma observed by echocardiography or fluoroscopy
- •15. Active bacterial endocarditis
- •16. History of bleeding diathesis or coagulopathy
- •17. History of stroke within the prior 6 months
- •18. Subjects in whom anticoagulation is contraindicated
- •19. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
- •20. Concurrent medical condition with a life expectancy of less than 12 months
- •21. Currently participating in an investigational study
- •22. Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, immunological abnormalities, and hematological abnormalities)
- •23. Subjects with indication for concomitant surgery such as coronary artery bypass graft (CABG), aortic valve reconstruction or replacement, tricuspid repair or replacement, left ventricular remodeling surgery and congenital repair
- •24. Any cardiac resynchronization therapy within the last 3 months prior to treatment
- •25. Subjects on high dose steroids or immunosuppressant therapy
- •26. Female subjects who are pregnant, of child bearing potential or lactating
- •27. Subjects who are unable or unwilling to comply with the follow-up schedule and requirements
研究者
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