None listed
Conditions
Interventions
Intervention1: BACE Device: Implantation
Control Intervention1: Nil: Nil
Sponsors
Mardil Medical Medical Devices Pvt Ltd.
20B, ASCI College Park,
Road #3, Banjara Hills,
Hyderabad 500034, India
CRO:
Manipal Acunova Limited
Mobius Towers, SJR i Park
EPIP, Whitefield
Bangalore - 560 066 India
Ph : 08066915700
Fax : 08066915719
Eligibility
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All device and surgery-related averse events and other adverse events over the course of the studyTimepoint: At baseline, post implantaion, at hospital discharge,1, 3, 6, and 12 month post implantaion;Primary Outcome: Reduction of MR by at least one grade after the implantation of the BACE device as measured by ECHO cardiographic parametersTimepoint: at baseline, peri surgery (just before and right after BACE device implantation), at hospital discharge, 1, 3, 6, and 12 months post device implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Durability of or improvement in MR grade over the 12-month follow-up period as measured by echocardiography Improvement in cardiac functionality [as assessed by the NYHA functional class, and Minnesota Living with Heart Failure questionnaire (MLHFQ) over the 12-month follow-up periods. NYHA status, and MLHFQ evaluations at baseline, discharge from hospital,1, 3, 6, and 12 months post BACE Device implantation. Timepoint: NYHA status, and MLHFQ evaluations at baseline, hospital discharge, 1, 3, 6, and 12 months post BACE Device implantation. | — |
Countries
India
Contacts
Public ContactDr. Krishna Talluri
Outcome results
None listed