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

NCT02701972 | Unknown DMC

• 1 other identifier: BACE CT003
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Two years

Secondary Outcomes (5)

• 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

  Two years

• Improvement in cardiac functionality as assessed by the NYHA functional class

  Two years

• Improvement in cardiac functionality as assessed by the 6-minute walk

  Two years

• Improvement in cardiac functionality

  Two years

• All device and surgery-related averse events

  Two years

Study Arms (1)

Control and Test

EXPERIMENTAL

Pre-implantation and Post-implantation of BACE device

Device: BACE Device

Interventions

BACE Device DEVICE

Implanted BACE device

Control and Test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Functional Mitral Valve Regurgitation (FMR) of moderate to severe grade (2 to 4 as per the American College of Cardiology and American Heart Association 2006 Classification of Mitral regurgitation evaluation)
• Symptomatic- NYHA Class II to IV
• Left Ventricular Ejection Fraction (LVEF) 25%-50%
• Normal mitral valve leaflets without any abnormalities and damage
• Subject is willing and available to return for study follow-up
• Surgical approach is the treatment option
• Ability of the subject or legal representative to understand and provide signed consent for participating in the study

You may not qualify if:

• Known hypersensitivity or allergy to the device materials
• History or presence of rheumatic heart disease
• Structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets)
• Severe pulmonary hypertension, defined by pulmonary artery systolic (PAS) pressure greater than or equal to 60 mm Hg
• Grade 4 diastolic dysfunction of left ventricle on ECHO, with no change by hemodynamic maneuvers.
• ST segment \[of an electrocardiogram\] (ST) segment elevation myocardial infarction \[MI\] within 30 days of enrollment in the study; non ST segment elevation Myocardial Infarction (MI) within 7days of enrollment in the study
• Currently enrolled in another investigational drug or device study
• Subjects with intra-operative \[correlate to pre-op measurement end diastolic dimension\] heart circumference outside of offered BACE device size ranges \[21 to 41 cm\]
• Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the BACE
• Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures
• Abnormalities in the mitral valve leaflets that would necessitate mitral valve reconstruction or replacement
• Prior Coronary Artery Bypass Graft (CABG) surgery
• Acute active infection
• Active peptic ulcer
• History of IV drug abuse

Sponsors & Collaborators

• Phoenix Cardiac Devices, Inc.: lead
• Toronto General Hospital: collaborator

Study Officials

• Vivek Rao, MD PhD

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: BACE device implant

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 8, 2016
• Study Start: March 1, 2016
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share