Mitral Valve RegurgitationMAVERICNCT02302872
Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation
A study testing ARTO System in people with Mitral Valve Regurgitation, run by Mvrx, Inc. at 9 sites in 5 countries.
Trial summary
The objective of the study is to evaluate the safety and performance 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 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- 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
- 51 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Oct 2013to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
- Age ≥ 18
- 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+
- LVEF ≥20% ≤ 50%
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- LVEDD > 50 mm and ≤ 70 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 a candidate for surgery, and the use of the ARTO™ System is technically feasible.
Who cannot join
- 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
- History of, or active, rheumatic heart disease
Show all 10Show fewer
- 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
- Biventricular pacing initiated or anticipated within 6 months of the planned investigational procedure
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Australia4 sites
St Andrews Hospital
Adelaide, South Australia, 5000
The Wesley Hospital
Auchenflower, Queensland, 4066
Warringal Private Hospital
Heidelberg
The Mount Hospital
Perth
United Kingdom2 sites
Brighton and Sussex University Hospitals
Brighton
St Thomas' Hospital
London
About this study
Official title: Mitral Valve Repair Clinical Trial (MAVERIC Trial)
The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
- Conditions
- Mitral Valve Regurgitation
- 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
| 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.
Major Adverse Event Rate to 30 Days post-procedure
Major Adverse Events defined as: death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure
Measured: <=30 days post procedure
Mitral regurgitation grade and change from baseline to 30 days
Measured: <=30 days post procedure
Device Technical Success
At exit from cath lab, alive, with Successful access, delivery and retrieval of the device delivery system, and Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
Measured: procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve 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
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mvrx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrejs Erglis, MD, Principal investigator, Pauls Stradins Clinical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302872
- Sponsor's protocol ID
- EU010513, AU220816
- Acronym
- MAVERIC
- Status last verified
- Apr 2021
- First submitted
- 18 Nov 2014
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Erglis A, Narbute I, Poupineau M, Hovasse T, Kamzola G, Zvaigzne L, Erglis M, Erglis K, Greene S, Rogers JH. Treatment of Secondary Mitral Regurgitation in Chronic Heart Failure. J Am Coll Cardiol. 2017 Dec 5;70(22):2834-2835. doi: 10.1016/j.jacc.2017.09.1110. No abstract available.
PubMed 29191334Rogers JH, Thomas M, Morice MC, Narbute I, Zabunova M, Hovasse T, Poupineau M, Rudzitis A, Kamzola G, Zvaigzne L, Greene S, Erglis A. Treatment of Heart Failure With Associated Functional Mitral Regurgitation Using the ARTO System: Initial Results of the First-in-Human MAVERIC Trial (Mitral Valve Repair Clinical Trial). JACC Cardiovasc Interv. 2015 Jul;8(8):1095-1104. doi: 10.1016/j.jcin.2015.04.012. Epub 2015 Jun 24.
PubMed 26117461
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)
- ClinicalTrials.gov ID
- NCT02302872
- Acronym / sponsor ID
- MAVERIC / EU010513, AU220816
- Conditions
- Mitral Valve Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Mvrx, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 27 Nov 2014 (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 objective of the study is to evaluate the safety and performance 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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
- Age ≥ 18
- 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+
Key exclusion criteria (10 listed)
- 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
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 System | Device | ARTO system |
Primary outcome
Major Adverse Event Rate to 30 Days post-procedure
Time frame: <=30 days post procedure
Major Adverse Events defined as: death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure
Mitral regurgitation grade and change from baseline to 30 days
Time frame: <=30 days post procedure
Device Technical Success
Time frame: procedural
At exit from cath lab, alive, with Successful access, delivery and retrieval of the device delivery system, and Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 29191334Erglis A, Narbute I, Poupineau M, Hovasse T, Kamzola G, Zvaigzne L, Erglis M, Erglis K, Greene S, Rogers JH. Treatment of Secondary Mitral Regurgitation in Chronic Heart Failure. J Am Coll Cardiol. 2017 Dec 5;70(22):2834-2835. doi: 10.1016/j.jacc.2017.09.1110. No abstract available.
- Derived from this study: PubMed 26117461Rogers JH, Thomas M, Morice MC, Narbute I, Zabunova M, Hovasse T, Poupineau M, Rudzitis A, Kamzola G, Zvaigzne L, Greene S, Erglis A. Treatment of Heart Failure With Associated Functional Mitral Regurgitation Using the ARTO System: Initial Results of the First-in-Human MAVERIC Trial (Mitral Valve Repair Clinical Trial). JACC Cardiovasc Interv. 2015 Jul;8(8):1095-1104. doi: 10.1016/j.jcin.2015.04.012. Epub 2015 Jun 24.
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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.
Andrejs Erglis, MD principal investigator
Pauls Stradins Clinical University Hospital
9 sites in 5 countries: 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 Regurgitation, run by Mvrx, Inc. at 9 sites in 5 countries.
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 9 inclusion and 10 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 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 9 sites in Australia, United Kingdom, France, Italy, Latvia. 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?
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?
Major Adverse Event Rate to 30 Days post-procedure (time frame: <=30 days post procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302872, which also lists 2 linked publications.
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.