CTRI/2011/091/000195招募中未知
Evaluation of acute safety and efficacy of the BACE [Basal Annuloplasty of the Cardia Externally] device in the treatment of Function Mitral valve Regurgitation [FMR] - BACE CT001; MA-CT-08-004
Mardil Medical Device Pvt. Ltd.20B,ASCI College Park,Road#3,Banjara Hills,Hyderabad 500034, IndiaPh:+91-40-23550481Fax:+91-40-235504870 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
入选标准
- •?Adults from 18 to 80 years of age, inclusive; either gender
- •?Symptomatic functional MR of grade moderate to severe (2 to 4 as per the ACC and AHA 2006 Classification of Mitral regurgitation evaluation NYHA Class II to IV
- •?LVEF 25%-50%
- •?Normal mitral valve leaflets
- •?Subject is willing and available to return for study follow up
- •?Surgical approach is the treatment option
- •?Ability of the subject or legal representative to understand and provide signed consent for participating in the study
排除标准
- •?Subjects will be excluded if they meet any of the following criteria
- •?Known hypersensitivity or allergy to the device materials
- •?History or presence of rheumatic heart disease
- •?Structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets)
- •?Severe pulmonary hypertension, defined by pulmonary artery systolic (PAS) pressure greater than or equal to 60 mm Hg
- •?Severe diastolic dysfunction of left ventricle on ECHO [restrictive filling pattern, characterized by E>> A, decreased IVRT, and decreased DT as seen with restrictive cardiomyopathies with LV ejection fractions of > 40%)
- •?Transmural myocardial infarction [MI] with in 30 days of enrollment in the study; non ST segment elevation MI within 7days of enrollment in the study
- •?Currently enrolled in another investigational drug or device study
- •?Subjects with heart size outside of offered BACE device size ranges [25 to 41 cm; correlate to pre-op measurement end diastolic dimension]
- •?Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the BACE
- •?Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures
- •?Abnormalities in the mitral valve leaflets that would necessitate mitral valve reconstruction or replacement
- •?Prior Coronary Artery Bypass Graft (CABG) surgery
- •?Acute active infection
- •?Active peptic ulcer
- •?History of IV drug abuse
- •?Chronic renal failure requiring dialysis
- •?Creatinine > 2.5 mg/dL
- •?Open chest surgery contraindication [e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis]
- •?Immune suppression therapy
- •?Subjects with chronic connective tissue disease
- •?Investigator judgment that body habitus or sternal anatomy precludes pericardial access
- •?Females who are pregnant or lactating
- •?Life expectancy of less than 12 months due to conditions other than cardiac status
研究者
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