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

NCT02701972 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-09-16

No results posted yet for this study

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.

Conditions

  • Functional Mitral Regurgitation

Interventions

DEVICE

BACE Device

Implanted BACE device

Sponsors & Collaborators

  • Toronto General Hospital

    collaborator OTHER

  • Phoenix Cardiac Devices, Inc.

    lead INDUSTRY

Principal Investigators

  • Vivek Rao, MD PhD · Toronto General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2021-06-30
Completion
2021-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02701972 on ClinicalTrials.gov