NL-OMON43333撤回不适用
REduction or eLimination of mItral rEgurgitation in degenerative or Functional mitral regurgitation with the CardiAQ-Edwards* Transcatheter Mitral Valve - The RELIEF Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 28
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. * 18 years old.
- •2. Willing and able to comply with all required follow-up evaluations and assessments.
- •3. Patient or authorized representative has read the informed consent, agrees to comply with the requirements, and has signed the informed consent to participate in the study.
- •Heart Failure Status
- •4. New York Heart Associate Classification * II
- •5. Left Ventricular Ejection Fraction * 30%.
- •6. Mitral regurgitation (MR) * Grade 3+ (moderate/severe, or severe per Appendix D).
- •7. Patient is determined to be prohibitively high surgical risk per MVARC definition as assessed by the site*s Heart Team (a minimum of one Cardiac Surgeon and one Interventional Cardiologist).
- •8. Left atrial height * 4 cm.
- •9. Mitral valve major annulus diameter meets the range of 35-45 mm via CT.
- •10. Angle of mitral valve axis to aortic valve axis is deemed unlikely to be obstructive by the Investigator.
- •11. Suitable left ventricular anatomy for delivery system access per the medical opinion of the Investigator (Transapical Only).
- •23. Absence of CRT with Class I indication criteria for biventricular pacing
- •24. Hypotension (systolic pressure <90mmHg) or requirement for inotropic support or mechanical hemodynamic support.
- •25. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or nonischemic etiology.
- •26. Untreatable hypersensitivity or contraindication to any of the following:
- •* Aspirin and Clopidogrel and Ticlopidine,
- •* Heparin and Bivalirudin,
- •* Warfarin, Nitinol alloys (nickel and titanium), contrast media, glutaraldehyde or bovine tissue.
- •27. Bleeding diathesis or coagulopathy, or patient refuses blood transfusion.
- •28. Active peptic ulcer or GI bleeding.
- •29. Fixed pulmonary artery systolic pressure >70 mmHg.
- •30. Severe right ventricular systolic dysfunction.
- •31. Severe tricuspid valve regurgitation requiring intervention.
- •32. Pulmonary function FEV1 (< 750 cc).
- •33. Patients with renal insufficiency (creatinine > 2.2 mg/dL) on lab test * 48 hours prior to scheduled implant procedure and not already receiving dialysis.
- •34. Liver disease, cirrhosis of the liver (CTP B or C) or significantly abnormal liver function test results.
- •35. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months.
- •36. Active infection that requires antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 3 weeks prior to treatment.
- •37. Pregnant or planning pregnancy within 12 months after enrollment.
排除标准
- •1. Currently participating in another investigational drug or device study.
- •2. Need for emergent or urgent surgery for any reason.
- •3. Any condition that, in the opinion of the Investigator, could interfere with patient participation, confound the study results or interfere with study compliance.
- •4. Lack of chordal support of the mitral valve (i.e., ruptured papillary muscle or secondary chords).
- •5. Severe calcification of any component of the mitral valve, including one or both of the mitral leaflets.
- •6. Myocardial infarction within the previous 6 weeks.
- •7. Intra-cardiac thrombus, mass or vegetation.
- •8. Aneurysmal dilatation of the left ventricular apex (Transapical Only).
- •9. Need for native aortic, tricuspid or pulmonic valve repair or replacement.
- •10. History of atrial septal repair (Transseptal Only).
- •11. Implanted inferior vena cava (IVC) filter (Transseptal Only).
- •Existing Co-morbidities
- •12. Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve.
- •13. Pre-existing mechanical prosthetic valve in the aortic position.
- •14. Pre-existing device in the LV apex (Transapical Only).
- •15. History of cardiac transplantation.
- •16. Any history of ilio-femoral deep vein thrombosis (Transseptal Only).
- •17. Clinically significant, untreated coronary artery disease.
- •18. Percutaneous coronary intervention, TAVR, carotid surgery, CRT, CRT-D, ICD or pacemaker within the prior 30 days.
- •19. Contraindication to Transesophageal Echocardiography (TEE).
- •20. Active endocarditis or rheumatic heart disease within the previous 3 months.
- •21. Stroke or TIA within the previous 3 months.
- •22. Uncontrolled atrial fibrillation.
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