Health Condition 1: null- Functional Mitral Valve Regurgitation
Conditions
Interventions
Intervention1: BACE device: The BACE device is based on a new technique that provides support and remodels the base of the heart externally. By doing so it brings the mitral valve leaflets closer for
Sponsors
Phoenix Cardiac Devices Pvt Ltd
JSS Medical Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) 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
Exclusion criteria
Exclusion criteria: 1) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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.Timepoint: 24 Months follow up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
Canada, Czech Republic, India, Poland, United Kingdom
Contacts
Public ContactGopal Muppirala
JSS Medical Research India Private Limited
Outcome results
None listed