CTRI/2012/10/003045招募中不适用
Evaluation of Safety and Efficacy of the BACEâ„¢ [Basal Annuloplasty of the CardiaExternally] Device in the Treatment of Functional Mitral Valve Regurgitation [FMR]
Phoenix Cardiac Devices Pvt Ltd10 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年8月10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
- 10
- 主要终点
- The primary efficacy end point will be reduction of MR to 1 plus or less from the baseline MR Grade through the 24-month study period.
研究概览
简要总结
This study is open label, multi centretrial to evaluate the safety and efficacy of the BACE device in the patients ofFunctional Mitral Regurgitation whom surgery is preferred treatment as per theInvestigator.
The primary efficacy endpoint will bereduction of MR to 1+ or less from the baseline MR grade through the 6 monthstudy periods.
Primary safety endpoint will be freedomfrom major devise and surgery-related adverse
events for the duration of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults from 18 to 80 years of age, inclusive; either gender 2) Functional MR of moderate to severe grade (2 to 4 as per the ACC and AHA 2006 Classification of Mitral regurgitation evaluation) 3) Symptomatic- NYHA Class II to IV 4) LVEF 25%-50% 5) Normal mitral valve leaflets without any abnormalities and damage 6) Subject is willing and available to return for study follow-up 7) Surgical approach is the treatment option 8) Ability of the subject or legal representative to understand and provide signed consent for participating in the study.
排除标准
- •Known hypersensitivity or allergy to the device materials 2) History or presence of rheumatic heart disease 3) Structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets) 4) Severe pulmonary hypertension, defined by pulmonary artery systolic (PAS) pressure greater than or equal to 60 mm Hg 5) Grade 4 diastolic dysfunction of left ventricle on ECHO, with no change by hemodynamic maneuvers 6) ST segment elevation myocardial infarction [MI] within 30 days of enrollment in the study; non ST segment elevation MI within 7days of enrollment in the study 7) Currently enrolled in another investigational drug or device study 8) Subjects with intra operative [correlate to pre-op measurement end diastolic dimension] heart circumference outside of offered BACE device size ranges [25 to 41 cm] 9) Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the BACE 10) Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures 11) Abnormalities in the mitral valve leaflets that would necessitate mitral valve reconstruction or replacement 12) Prior Coronary Artery Bypass Graft (CABG) surgery 13) Acute active infection 14) Active peptic ulcer 15) History of IV drug abuse 16) Chronic renal failure requiring dialysis 17) Creatinine 2.5 mg/dL 18) Open chest surgery contraindication [e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis] 19) Immune suppression therapy including corticosteroids 20) Subjects with chronic connective tissue disease •Investigator judgment that body habitus or sternal anatomy precludes pericardial access 21) Females who are pregnant or lactating 22) 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 end point will be reduction of MR to 1 plus or less from the baseline MR Grade through the 24-month study period.
时间窗: 24 Months follow up period
Primary safety endpoint will be freedom from major device and surgery related adverse events (listed in the adverse events section) for the duration of the 24 month follow up period.
时间窗: 24 Months follow up period
次要结局
- Not Applicable(Not Applicable)
研究者
研究点 (10)
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