A CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THE BACE DEVICE IN THE TREATMENT OF FUNCTIONAL MITRAL REGURGITATIO

Not Applicable

• Registration Number: CTRI/2011/091/000195
• Lead Sponsor: Mardil Medical Device Pvt. Ltd.20B,ASCI College Park,Road#3,Banjara Hills,Hyderabad 500034, IndiaPh:+91-40-23550481Fax:+91-40-23550487

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 60

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

?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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Durability of or improvement in MR grade over the additional 18-month follow-up period as measured by echocardiography<br>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.<br>Timepoint: