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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Mitral Valve Repair Clinical Trial (MAVERIC Trial)
Secondary ID [1] 0 0
EU010513, AU220816
Universal Trial Number (UTN)
Trial acronym
MAVERIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Valve Regurgitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ARTO System

Experimental: ARTO system -


Treatment: Devices: ARTO System


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
<=30 days post procedure
Primary outcome [2] 0 0
Mitral regurgitation grade and change from baseline to 30 days
Timepoint [2] 0 0
<=30 days post procedure
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
procedural

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
The Wesley Hospital - Auchenflower
Recruitment hospital [2] 0 0
St Andrews Hospital - Adelaide
Recruitment hospital [3] 0 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [4] 0 0
The Mount Hospital - Perth
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Massy
Country [2] 0 0
Italy
State/province [2] 0 0
Milan
Country [3] 0 0
Latvia
State/province [3] 0 0
Riga
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Brighton
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mvrx, Inc.
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT02302872
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrejs Erglis, MD
Address 0 0
Pauls Stradins Clinical University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications