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Evaluation of Safety and Efficacy of the BACE™ Device in the Treatment of Functional Mitral Valve Regurgitation [FMR — BACE  

Functional Mitral Regurgitation Clinical 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]

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02701972
Study type Interventional
Source Phoenix Cardiac Devices, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date March 2016
Completion date September 30, 2021
View Details
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