Evaluation of Safety and Efficacy of the BACE™ Device in the Treatment of Functional Mitral Valve Regurgitation [FMR (BACE)
ClinicalTrials.gov Identifier: NCT02701972
This study is enrolling participants by invitation only.
Phase 1 Trial
Official Title: Evaluation of Safety and Efficacy of the Basal Annuloplasty of the Cardia Externally (BACE™) [Basal Annuloplasty of the Cardia Externally] Device in the Treatment of Functional Mitral Valve Regurgitation [FMR]
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.
Primary Outcome Measures:
- Reduction in MR grade to MR grade 1+ or less [ Time Frame: Two years ]
Reduction in Mitral Valve Regurgitation (MR) grade to MR grade 1+ or less after the implantation of the BACE Device as measured by echocardiography.
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.