DRKS00000316招募中不适用
SATURN I Trial - Safety and performance Assessment of Therapeutic Ultrasound for the treatment of mitral RegurgitatioN - SATUR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Female and male patients 18 years of age or older
- •2. Patients with Functional Mitral Valve Insufficiency or regurgitation greater than or equal to 2 to 4+ on a scale of 4+
- •3. Long Axis of Mitral Valve is < 4.5 cm by TTE
- •4. Severe co-morbidities which reveal a predicted risk of operative mortality of 15% and a minimum STS risk calculator score of 8%
- •5. Negative pregnancy test for female patients of childbearing potential
- •6. Available for follow-up for at least twelve (12) months.
- •7. Willing and able to provide signed, informed consent and willing and able to comply with follow-up requirements.
排除标准
- •1. Severe calcification of annulus or leaflets in which calcification is visible under fluoroscopy.
- •2. Mitral Stenosis
- •3. Mitral valve prolapse (moderate to severe).
- •4. History of mitral endocarditis.
- •5. Ruptured chordae tendinae or papillary muscle.
- •6. Long Axis of Mitral Valve is greater than or equal to 4.5 cm by TTE
- •7. Previous interventional or surgical treatment for MV Disease.
- •8. Subjects with ischemia requiring cardiac revascularization
- •(percutaneous or surgical within 3 months prior to or planned after PMVR procedure.
- •9. An implanted coronary Stent in the Left Circumflex Artery or in close proximity to the mitral annulus.
- •10. Previous or required repair or replacement of any other non-mitral cardiac valve
- •11. Unstable Angina defined by one of the following criteria within the last 30 days: Angina that occurred at rest and was prolonged, usually lasting more than 20 minutes, New-onset angina of at least Canadian Cardiovascular Society (CCS) class III severity, and/or Recent acceleration of angina reflected by an increase in severity of at least 1 CCS class to at least CCS class III Positive CK-MB.
- •12. Acute MI within the last 30 days.
- •13. Congestive Heart failure with NYHA IV.
- •14. LV end-diastolic thickness of septal and posterior walls as measured in the parasternal long-axis view to be greater than 1.5 cm.
- •15. Current or history of left atrial thrombus (even if treated)
- •16. Ejection fraction less than 25%
- •17. History of stroke or transient ischemic attack within the last 3 months
- •18. Previous difficulty in obtaining vascular or transseptal access
- •19. Known untreated coagulopathy
- •20. Known life threatening, non-cardiac disease that will limit the
- •subject's life expectancy to less than one year
- •21. Creatinine greater than 2.0 mg/dl or equivalent units.
- •22. Allergy to Contrast Media
- •23. Known alcohol or drug abuser.
- •24. Currently participating in the study of an investigational drug or device.
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