CTRI/2011/091/000195招募中不适用
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]
Mardil Medical Device Pvt. Ltd.20B,ASCI College Park,Road#3,Banjara Hills,Hyderabad 500034, IndiaPh:+91-40-23550481Fax:+91-40-235504874 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年2月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The primary efficacy endpoint: Reduction in MR grade to 1+ or less after the implantation of the BACE device and through the 6 month feasibility phase as measured by echocardiography
研究概览
简要总结
This study is open label, multi centre trial to evaluate the safety and efficacy of the BACE device in the patients of Functional Mitral Regurgitation whom surgery is preferred treatment as per the Investigator. The primary efficacy endpoint will be reduction of MR to 1+ or less from the baseline MR grade through the 6 month feasibility phase. Primary safety endpoint will be freedom from major devise and surgery-related adverse events for the duration of 6 months. Total 20 patients will be enrolled in India.
研究设计
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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.
结局指标
主要结局
The primary efficacy endpoint: Reduction in MR grade to 1+ or less after the implantation of the BACE device and through the 6 month feasibility phase as measured by echocardiography
次要结局
- Durability of or improvement in MR grade over the additional 18-month follow-up period as measured by echocardiographyImprovement in cardiac functionality [as assessed by the NYHA functional class, and Minnesota Living with Heart Failure questionnaire] over the initial 6 month feasibility and the additional 18-month follow-up periods.
研究者
研究点 (4)
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