Mitral Valve InsufficiencyMAVERIC USNCT03311295
MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial) - United States
A study testing ARTO System in people with Mitral Valve Insufficiency, run by Mvrx, Inc. at 1 site in United States.
Trial summary
The objective of the study is to evaluate the safety and feasibility of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF). Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- ARTO System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2018to 26 Apr 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates must meet ALL of the following criteria to be enrolled in the study.
- Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
- Age 21-85, inclusive
- Trans-septal catheterization is determined to be feasible by the treating physician
- NYHA class II-IV heart failure of any etiology
- Symptomatic with MR grade ≥ 2+
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- LVEF < 40%
- LVEDD > 50 mm and ≤ 75 mm
- No anticipated change in patient's cardiac medication regimen anticipated throughout the course of the study.
- In the opinion of the investigator and heart surgery team, the patient is not an appropriate candidate for surgery, and the use of the ARTO System is technically feasible
Who cannot join
- Candidates will be excluded from enrollment in the study if ANY of the following conditions apply.
- In the opinion of the Investigator, the femoral vein and internal jugular vein cannot accommodate a 16 F catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral DVT is present
- Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet calcification)
- Significant mitral annular calcification
- Hemodynamic instability (systolic pressure < 90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)
- Prior mitral valve surgery or valvuloplasty or any currently implanted prosthetic valve or VAD
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- History of, or active, rheumatic heart disease
- History of Atrial Septal Defects (ASD), whether repaired or not
- History of previously repaired PFO or PFO associated with clinical symptoms (e.g., cerebral ischemia) within 6 months of the planned investigational procedure
- In the opinion of the investigator, an atrial septal aneurysm is present that may interfere with transseptal crossing
- Serum creatinine > 2.5 mg/dL or dialysis dependent
- No access to coronary sinus and/or great cardiac vein
- Platelet count < 100 x 103 cells/mm3
- Evidence of active infection (fever with temperature > 38°C and/or WBC > 15,000) or endocarditis
- Echocardiographic evidence of mass intracardiac thrombus
- Patients on prescribed dual antiplatelet therapy (asprin + any P2Y12 inhibitor) that cannot be discontinued.
- Percutaneous coronary intervention or surgery anticipated within the 6 month follow up period following the investigational procedure
- Biventricular pacing initiated or anticipated within 6 months of the planned investigational procedure
- Evidence of an acute myocardial infarction within 12 weeks of the planned investigational procedure
- Stroke or TIA within 6 months of the planned investigational procedure
- GI bleeding within 6 months of the planned investigational procedure
- Intravenous drug abuse or suspected inability to adhere to follow-up
- Patients in whom TTE, TEE or ICE is contraindicated
- Contraindication to CT scan
- A known hypersensitivity or contraindication to study or procedure medications (specifically aspirin, clopidogrel and heparin) that cannot be adequately managed medically
- A known allergy or hypersensitivity to nickel
- A known need for any other cardiac surgery including surgery for coronary artery disease, atrial fibrillation, pulmonic, aortic or tricuspid valve disease
- In the judgment of the Investigator, patients in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads
- Irreversible bleeding disorder, history of bleeding diathesis or coagulopathy or refuses blood transfusion
- Evidence of disease or condition expected to compromise survival (< 1 year) or ability to complete follow-up assessments
- Pregnant or breastfeeding women
- Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. [Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials]
- Patient not a candidate for emergent surgical bailout in case of need
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
The objective of the study is to evaluate the safety and feasibility of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
- Conditions
- Mitral Valve Insufficiency
- Being tested
- ARTO System
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTO SystemDevice
The ARTO System directly reshapes the mitral annulus promoting leaflet coaptation and amelioration of regurgitation.
| Study group | Role | What they receive |
|---|---|---|
| ARTO System | Experimental | Not described Receives: Device: ARTO System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Major Adverse Event Rate to 30 Days post-procedure
Major Adverse Events (MAEs) will be categorized and defined in accordance with the relation to the procedure and device.
Measured: 30 days post procedure
Efficacy: Mitral regurgitation grade by ASE criteria and change from baseline to 1 year
Mitral regurgitation grade by ASE criteria and change from baseline to 1 year evaluated by 2-D transthoracic echocardiogram
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start3 Apr 2018
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Why it stopped: Lagging enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies 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
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mvrx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reginald Low, MD, Principal investigator, University California Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311295
- Sponsor's protocol ID
- US042616
- Acronym
- MAVERIC US
- Status last verified
- Apr 2021
- First submitted
- 11 Oct 2017
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial) - United States
- ClinicalTrials.gov ID
- NCT03311295
- Acronym / sponsor ID
- MAVERIC US / US042616
- Conditions
- Mitral Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lagging enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mvrx, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 17 Oct 2017 (actual)
- 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 objective of the study is to evaluate the safety and feasibility of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARTO System | Experimental | Device: ARTO System |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Candidates must meet ALL of the following criteria to be enrolled in the study.
- Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
- Age 21-85, inclusive
- Trans-septal catheterization is determined to be feasible by the treating physician
- NYHA class II-IV heart failure of any etiology
Key exclusion criteria (33 listed)
- Candidates will be excluded from enrollment in the study if ANY of the following conditions apply.
- In the opinion of the Investigator, the femoral vein and internal jugular vein cannot accommodate a 16 F catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral DVT is present
- Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet calcification)
- Significant mitral annular calcification
- Hemodynamic instability (systolic pressure < 90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)
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 |
|---|---|---|
| ARTO SystemThe ARTO System directly reshapes the mitral annulus promoting leaflet coaptation and amelioration of regurgitation. | Device | ARTO System |
Primary outcome
Safety: Major Adverse Event Rate to 30 Days post-procedure
Time frame: 30 days post procedure
Major Adverse Events (MAEs) will be categorized and defined in accordance with the relation to the procedure and device.
Efficacy: Mitral regurgitation grade by ASE criteria and change from baseline to 1 year
Time frame: Baseline to 1 year
Mitral regurgitation grade by ASE criteria and change from baseline to 1 year evaluated by 2-D transthoracic echocardiogram
Results and safety
The study was stopped early (reason given: Lagging enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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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.
Reginald Low, MD principal investigator
University California Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARTO System in people with Mitral Valve Insufficiency, run by Mvrx, Inc. at 1 site in United States.
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 10 inclusion and 33 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: stopped early, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Lagging enrollment). 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?
Safety: Major Adverse Event Rate to 30 Days post-procedure (time frame: 30 days post procedure). The study lists 2 primary outcomes in all. 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 28 Apr 2021.