A clinical trial to assess the safety and efficacy of the BACE device forthe treatment of functional mitral valve regurgitatio
- Conditions
- Health Condition 1: null- Functional Mitral Valve Regurgitation
- Registration Number
- CTRI/2012/10/003045
- Lead Sponsor
- Phoenix Cardiac Devices Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br> <br/ ><br>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 Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable