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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02302872
Registration number
NCT02302872
Ethics application status
Date submitted
18/11/2014
Date registered
27/11/2014
Date last updated
28/04/2021
Titles & IDs
Public title
Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation
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Scientific title
Mitral Valve Repair Clinical Trial (MAVERIC Trial)
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Secondary ID [1]
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EU010513, AU220816
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Universal Trial Number (UTN)
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Trial acronym
MAVERIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mitral Valve Regurgitation
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - ARTO System
Experimental: ARTO system -
Treatment: Devices: ARTO System
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Major Adverse Event Rate to 30 Days post-procedure
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Assessment method [1]
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Major Adverse Events defined as: death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure
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Timepoint [1]
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<=30 days post procedure
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Primary outcome [2]
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Mitral regurgitation grade and change from baseline to 30 days
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Assessment method [2]
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Timepoint [2]
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<=30 days post procedure
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Primary outcome [3]
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Device Technical Success
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Assessment method [3]
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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
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Timepoint [3]
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procedural
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Eligibility
Key inclusion criteria
1. Is ambulatory, able and willing to comply with the study protocol and has provided
written informed consent
2. Age = 18
3. Trans-septal catheterization is determined to be feasible by the treating physician
4. NYHA class II-IV heart failure of any etiology
5. Symptomatic with MR grade = 2+
6. LVEF =20% = 50%
7. LVEDD > 50 mm and = 70 mm
8. No anticipated change in patient's cardiac medication regimen anticipated throughout
the course of the study.
9. • 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. 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
2. Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet
calcification)
3. Significant mitral annular calcification
4. Hemodynamic instability (systolic pressure < 90 mmHg without afterload reduction or
cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)
5. Prior mitral valve surgery or valvuloplasty or any currently implanted prosthetic
valve or VAD
6. History of, or active, rheumatic heart disease
7. History of Atrial Septal Defects (ASD), whether repaired or not
8. History of previously repaired PFO or PFO associated with clinical symptoms (e.g.,
cerebral ischemia) within 6 months of the planned investigational procedure
9. In the opinion of the investigator, an atrial septal aneurysm is present that may
interfere with transseptal crossing
10. Biventricular pacing initiated or anticipated within 6 months of the planned
investigational procedure
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2021
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Actual
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Sample size
Target
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Accrual to date
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Final
51
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Recruitment in Australia
Recruitment state(s)
QLD,SA
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Recruitment hospital [1]
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The Wesley Hospital - Auchenflower
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Recruitment hospital [2]
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St Andrews Hospital - Adelaide
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Recruitment hospital [3]
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Warringal Private Hospital - Heidelberg
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Recruitment hospital [4]
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The Mount Hospital - Perth
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Recruitment postcode(s) [1]
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4066 - Auchenflower
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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- Heidelberg
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Recruitment postcode(s) [4]
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- Perth
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Massy
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Country [2]
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Italy
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State/province [2]
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Milan
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Country [3]
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Latvia
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State/province [3]
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Riga
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Country [4]
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United Kingdom
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State/province [4]
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Brighton
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Country [5]
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United Kingdom
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State/province [5]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Mvrx, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02302872
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Andrejs Erglis, MD
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Address
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Pauls Stradins Clinical University Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02302872
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