NL-OMON51133撤回不适用
An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Functional Mitral Regurgitation - AFIRE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 25
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. Moderate-to-severe non-primary Mitral Regurgitation (as assessed by
- •qualitative, semi-quantitative and/or quantitative echocardiographic assessment
- •in the setting of all of the following:
- •a. Severe left atrial (LA) dilatation as defined by at least two (2) of the
- •i. LA area * 41cm2
- •ii. Indexed LA volume > 48mL/m2
- •iii. LA diameter * 52 mm for men and * 46 mm for women
- •b. Preserved left ventricular contractility (Left Ventricular Ejection Fraction
- •*50% by Simpson*s biplane technique)
- •c. No more than mild left ventricular dilatation as defined by:
- •i. LV diastolic volume/BSA (mL/m2) <90 mL/m2 for men and <71 mL/m2 for women
- •ii. LV systolic volume/BSA (mL/m2) <39 mL/m2 for men and <33 mL/m2 for women
- •2. New York Heart Association (NYHA) Class II, III or ambulatory IV heart
- •3. Stable heart failure medication regimen for at least 30 days prior to index
- •procedure including antihypertensives and/or diuretics to achieve controlled BP
- •(< 140 mmHg systolic) and adequate heart rate control (<100 bpm resting HR)
- •4. Patient deemed appropriate candidate for transcatheter mitral valve repair
- •by the local multidisciplinary heart team
- •5. Subject meets anatomic screening criteria as determined by angiographic
- •screening at the time of the index procedure to ensure that implant can be
- •sized and placed in accordance with the Instructions for Use
- •6. Female subjects of child-bearing potential must have a negative serum *HCG
- •7. Age * 18 years old
- •8. The subject has read the informed consent, agrees to comply with the
- •requirements, and has signed the informed consent to participate in the study
排除标准
- •1. Hospitalization in past three (3) months due to myocardial infarction,
- •coronary artery bypass graft surgery, and/or unstable angina
- •2. Evidence of transient ischemic attack or stroke within three (3) months
- •prior to intervention
- •3. Percutaneous coronary intervention in the last 30 days
- •4. Subjects expected to require any cardiac surgery, including surgery for
- •coronary artery disease or for pulmonic, aortic, or tricuspid valve disease
- •within one (1) year
- •5. Subjects expected to require any percutaneous coronary intervention within
- •30 days of the index procedure.
- •6. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great
- •cardiac vein (GCV), or anticipated need for cardiac resynchronization therapy
- •(CRT) within twelve (12) months
- •7. Presence of a coronary artery stent under the CS / GCV in the implant target
- •8. Presence of left atrial appendage (LAA) clot.
- •9. Presence of primary renal dysfunction or significantly compromised renal
- •function as reflected by a serum creatinine > 2.2 mg/dL (194.5 *mol/L) OR
- •estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
- •10. Poorly controlled atrial fibrillation or flutter, with poor ventricular
- •rate control (> 100 bpm resting HR), or other poorly controlled symptomatic
- •brady- or tachy-arrhythmias
- •11. Uncontrolled hypertension (BP > 180 mmHg systolic and/or >105 mmHg
- •diastolic) or hypotension (BP < 90 mmHg systolic) at baseline
- •12. Presence of severe mitral annular calcification
- •13. Prior mitral valve surgery
- •14. Presence of a mechanical mitral heart valve, mitral bio-prosthetic valve or
- •mitral annuloplasty ring
- •15. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- •16. Active endocarditis
- •17. Severe aortic stenosis (aortic valve area <1.0 cm2) or severe aortic
- •regurgitation
- •18. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis,
- •sarcoidosis)
- •19. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive
- •pericarditis, or any other structural heart disease causing heart failure other
- •than atrial functional mitral regurgitation
- •20. Subjects with echocardiographic documentation of non-compaction
- •cardiomyopathy with associated hypercontractility of the cardiac structures
- •supporting the mitral annulus
- •21. Hemodynamic instability requiring inotropic support or mechanical heart
- •circulatory support
- •22. Active infections requiring current antibiotic therapy
- •23. Severe right ventricular failure or severe tricuspid regurgitation
- •24. History of bleeding diathesis or coagulopathy, or subject who refuses blood
- •transfusions
- •25. Significant organic mitral valve pathology (e.g., moderate or severe
- •myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic
- •disease, full or partial chordal rupture)
- •26. Allergy to contrast dye that cannot be pre-medicated
- •27. Pregnant or planning pregnancy within next 12 months.
- 另有 6 项未显示
研究者
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