None listed
Conditions
Interventions
Intervention1: BACE Device: BACE Device
Control Intervention1: Not Applicable:
Sponsors
Mardil Medical Device Pvt. Ltd.
20B,ASCI College Park,
Road#3,Banjara Hills,
Hyderabad 500034, India
Ph:+91-40-23550481
Fax:+91-40-23550487
Manipal Acunova Limited, Mobius Towers, SJR i Park EPIP, Whitefield,
Bangalore - 560 066, India
Max Neeman International Limited.
Max House, 1 Dr Jha Marg,
Okhla Phase 3
New Delhi 110021
Phone: +91.11.2632 4059, 2632 2824
Fax: +91.11.2632 2846
Website: www.neeman-medical.com
Eligibility
Inclusion criteria
Inclusion criteria: ? 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
Exclusion criteria
Exclusion criteria: ? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 echocardiographyTimepoint: | — |
Secondary
| Measure | Time frame |
|---|---|
| Durability of or improvement in MR grade over the additional 18-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] over the initial 6 month feasibility and the additional 18-month follow-up periods. Timepoint: | — |
Countries
India
Contacts
Public ContactDr. Shariq Anwar
Director - Research and Clincial Cardiology
Outcome results
None listed