NCT02701972

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

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]

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Phoenix Cardiac Devices, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Functional Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	BACE Device	Implanted BACE device

Timeline

• Start date: 2016-03-01
• Primary completion: 2021-06-30
• Completion: 2021-09-30
• First posted: 2016-03-08
• Last updated: 2020-09-16