The preclinical and clinical evidence of safety and efficacy with the BACE device (concept and feasibility) paved the way for the evaluation of the BACE device in this prospective, multi-center, single-arm, self-controlled study for safety and efficacy in the treatment of functional MR in a maximum of 60 adult subjects. The primary efficacy endpoint will be reduction of MR grade to 1+ or less from the baseline MR grade through the 6 month study period. Primary safety endpoint will be freedom from major device and surgery-related adverse events for the duration of the 6 month follow up period. Patients will be followed up to two years.
The primary objective of this study is to assess the safety and efficacy of the BACE device for the treatment of FMR. Secondary objective is to assess the ease of deployment of the BACE device Study Population: Since this study is to assess the safety and efficacy of a new device, with no control arm or comparator, the number of subjects enrolled will be a maximum of 60. Approximately 8-10 sites are expected to be included in the study. The subject population is adults of 18 to 80 years of age, either gender, with FMR as specified in the inclusion and exclusion criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Implanted BACE device
Reduction in MR grade to MR grade 1+ or less
Reduction in Mitral Valve Regurgitation (MR) grade to MR grade 1+ or less after the implantation of the BACE Device as measured by echocardiography.
Time frame: Two years
Durability of or improvement in MR grade over the follow-up period as measured by echocardiography; profiles of the grades in MR based on ECHO at each time point will be plotted for each subject with description of individual percentage change
Durability of or improvement in MR grade over the follow-up period as measured by echocardiography
Time frame: Two years
Improvement in cardiac functionality as assessed by the NYHA functional class
Improvement in cardiac functionality as assessed by the New York Heart Association (NYHA) functional class
Time frame: Two years
Improvement in cardiac functionality as assessed by the 6-minute walk
Improvement in cardiac functionality as assessed by the 6-minute walk
Time frame: Two years
Improvement in cardiac functionality
Improvement in cardiac functionality as assessed by the Minnesota Living with Heart Failure questionnaire
Time frame: Two years
All device and surgery-related averse events
All device and surgery-related averse events (listed above) and other adverse events over the course of the study will be tabulated
Time frame: Two years
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