NL-OMON41986已完成不适用
A Clinical Study of the CardiAQ* Transcatheter Mitral Valve Implantation (TMVI) System<br>(Transapical Delivery System) - CardiAQ TMVI System
CardiAQ Valve Technologies, Inc.0 个研究点目标入组 45 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
- 45
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 64（—）
入选标准
- •1. * 65 years old.
- •2. Willing and able to comply with all required follow-up evaluations and assessments.
- •3. Subject 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 * III
- •5. Left Ventricular Ejection Fraction * 30%.
- •6. Mitral regurgitation (MR) * Grade 3+ (moderate/severe, or severe) using the AHA/ACC 2014 Guidelines for the Management of Patients with Valvular Heart Disease (as published in Circulation March 3, 2014).
- •7. STS mortality score * 8% or determined to be high or extreme surgical risk by a Cardiac Surgeon.
- •8. Hemodynamically stable while on heart failure medication for at least 30 days before the procedure.
- •9. Left atrial height * 4 cm.
- •10. Left Ventricular End Systolic Diameter (LVESD) * 6 cm.
- •11. Mitral valve major (single axis) annulus diameter meets the range of 36-39.5 mm.
- •12. Angle of mitral valve axis to aortic valve axis is deemed unlikely to be obstructive by the Investigator.
- •13. Suitable left ventricular anatomy for delivery system access per the medical opinion of the Investigator.
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 Subject 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. Need for native aortic or pulmonic valve replacement.
- •Existing Co-morbidities
- •9. Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve.
- •10. Pre-existing mechanical prosthetic valve in the aortic position.
- •11. History of cardiac transplantation.
- •12. Any history of pulmonary embolism.
- •13. Clinically significant, untreated coronary artery disease.
- •14. Percutaneous coronary intervention within the prior 30 days.
- •15. Contraindication to Transesophageal/Transoesophageal Echocardiography (TEE/TOE).
- •16. Active endocarditis or rheumatic heart disease within the previous 3 months.
- •17. Refractory, unstable angina.
- •18. Significant cerebral vascular event within the previous 3 months.
- •19. Atrial fibrillation with uncontrolled heart rate (> 100 bpm).
- •20. Hemodynamic instability (systolic pressure < 90 mmHg without afterload reduction, cardiogenic shock or the need for inotropic or intra-aortic balloon pump support).
- •21. Untreatable hypersensitivity or contraindication to any of the following:
- •* Aspirin and Clopidogrel and Ticlopidine, OR
- •* Heparin and Bivalirudin, OR
- •* Warfarin, Nitinol Alloys (nickel and titanium), contrast media, glutaraldehyde or bovine tissue.
- •22. Bleeding diathesis or coagulopathy, or Subject refuses blood transfusion.
- •23. Active peptic ulcer or GI bleeding.
- •24. Severe pulmonary hypertension (> 55 mmHg) and severe COPD (FEV1/FVC < 70% and FEV1 < 50% predicted FEV1).
- •25. Severe right ventricular systolic dysfunction.
- •26. Severe tricuspid valve regurgitation (Grade 4+)
- •27. Pulmonary function FEV1 (< 750 cc).
- •28. Subject has severe kidney disease with
- •* Creatinine level > 194 µmol/L (2.2 mg/dL) OR
- •* eGFR * 30 mL/min.
- •29. Liver disease, cirrhosis of the liver or significantly abnormal liver function test results.
- •30. Significant uncorrected endocrinology deficiency.
- •31. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months.
- •32. Active infections that requires antibiotic therapy (if temporary illness, Subjects may enroll 2 weeks after discontinuation of antibiotics). Subjects must be free from infection prior to treatment. Any required dental work should be completed a minimum of 3 weeks prior to treatment.
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