Functional Mitral RegurgitationBACENCT02701972
Evaluation of Safety and Efficacy of the BACE™ Device in the Treatment of Functional Mitral Valve Regurgitation [FMR
A study testing BACE Device in people with Functional Mitral Regurgitation, run by Phoenix Cardiac Devices, Inc..
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Mitral Regurgitation
- What is being tested?
- BACE Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
- Chronic renal failure requiring dialysis
- Creatinine > 2.5 mg/dl
- Open chest surgery contraindication [e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis]
- Immune suppression therapy including corticosteroids
- Subjects with chronic connective tissue disease
- Investigator judgment that body habitus or sternal anatomy precludes pericardial access
- Females who are pregnant or lactating
- Life expectancy of < 12 months due to conditions other than cardiac status
About this study
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.
Read the 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
- Being tested
- BACE Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BACE DeviceDevice
Implanted BACE device
| Study group | Role | What they receive |
|---|---|---|
| Control and Test | Experimental | Pre-implantation and Post-implantation of BACE device Receives: Device: BACE Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Durability of or improvement in MR grade over the follow-up period as measured by echocardiography
Measured: Two years
Improvement in cardiac functionality as assessed by the NYHA functional class
Improvement in cardiac functionality as assessed by the New York Heart Association (NYHA) functional class
Measured: Two years
Improvement in cardiac functionality as assessed by the 6-minute walk
Improvement in cardiac functionality as assessed by the 6-minute walk
Measured: Two years
Improvement in cardiac functionality
Improvement in cardiac functionality as assessed by the Minnesota Living with Heart Failure questionnaire
Measured: Two years
All device and surgery-related averse events
All device and surgery-related averse events (listed above) and other adverse events over the course of the study will be tabulated
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- BACE device implant
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Cardiac Devices, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Toronto General Hospital
- Responsible party
- Sponsor
- Investigators
- Vivek Rao, MD PhD, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701972
- Sponsor's protocol ID
- BACE CT003
- Acronym
- BACE
- Status last verified
- Sep 2020
- First submitted
- 17 Feb 2016
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT02701972
- Acronym / sponsor ID
- BACE / BACE CT003
- Conditions
- Functional Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Phoenix Cardiac Devices, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Toronto General Hospital
- Study start
- Mar 2016
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- BACE device implant
| Arm | Type | Receives |
|---|---|---|
| Control and Test | Experimental | Device: BACE DevicePre-implantation and Post-implantation of BACE device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BACE DeviceImplanted BACE device | Device | Control and Test |
Primary outcome
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.
5 secondary outcomes
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
Time frame: Two years
Improvement in cardiac functionality as assessed by the NYHA functional class
Time frame: Two years
Improvement in cardiac functionality as assessed by the 6-minute walk
Time frame: Two years
Improvement in cardiac functionality
Time frame: Two years
All device and surgery-related averse events
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Rao, MD PhD principal investigator
Toronto General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing BACE Device in people with Functional Mitral Regurgitation, run by Phoenix Cardiac Devices, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in MR grade to MR grade 1+ or less (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.