CTRI/2009/091/000577招募中2 期
Evaluation of acute safety and efficacy of the BACE [Basal Annuloplasty of the Cardia Externally] device in the treatment of Functional Mitral valve Regurgitation [FMR].
Mardil Medical Medical Devices Pvt Ltd.20B, ASCI College Park,Road #3, Banjara Hills, Hyderabad 500034, India0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- •- MR of grades 2 and above [Grade 2 or more functional mitral valve regurgitation per 2D or 3D transthoracic echocardiography, must be symptomatic which is defined as NYHA Class ≥ II or heart failure subject with MR
- •- Functional MR with coronary artery disease or aortic valve disease
- •- Subject undergoing concomitant coronary artery bypass graft or aortic valve surgery
- •- Appropriate valve anatomy [normal mitral valve leaflets]
- •- Subject is willing and available to return for study follow up
- •- 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
- •- Known hypersensitivity or allergy to the device materials
- •- NYHA Class IV after optimal medical therapy
- •- Structural abnormality of the mitral valve
- •- High pulmonary arterial pressure
- •- Severe diastolic dysfunction of left ventricle on ECHO
- •- 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 protocol that would interfere with this 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
- •- Ejection fraction < 25%
- •- Creatinine > 3.0 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
相似试验
招募中
不适用
A CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THE BACE DEVICE IN THE TREATMENT OF FUNCTIONAL MITRAL REGURGITATIOCTRI/2011/091/000195Mardil Medical Device Pvt. Ltd.20B,ASCI College Park,Road#3,Banjara Hills,Hyderabad 500034, IndiaPh:+91-40-23550481Fax:+91-40-2355048760
尚未招募
Unknown
Clinical trial of Beach Body Gummies (BBG) in weight management.CTRI/2023/05/052235Aesthetic Nutrition Pvt. Ltd.
已完成
2 期
To evaluate the clinical efficacy and safety of Bailing capsule in the treatment of patients with chronic kidney disease stage 2-4 (CKD stage 2-4)Stage 2 through 4 chronic kidney diseaseITMCTR2024000026Zhongda Hospital affiliated to Southeast University
尚未招募
3 期
Role Of Bala Taila Matra Basti In The Management Of Vandhyatwa ( Infertility)CTRI/2023/08/057151Dr Arpuli Johari
进行中（未招募）
1 期
clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndromeMedDRA version: 20.0Level: PTClassification code 10001843Term: Alport's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersAlport SyndromeEUCTR2016-004395-22-DEReata Pharmaceuticals, Inc.180