Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation (MAVERIC)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Mitral Valve Regurgitation
• Intervention / Treatment: Device: ARTO System

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Heidelberg, Australia
    • Warringal Private Hospital
  • Perth, Australia
    • The Mount Hospital
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • The Wesley Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • St Andrews Hospital
• France
  • Massy, France
    • ICPS
• Italy
  • Milan, Italy
    • IRCCS San Donato
• Latvia
  • Riga, Latvia, 1002
    • Pauls Stradins Clinical University Hospital
• United Kingdom
  • Brighton, United Kingdom
    • Brighton and Sussex University Hospitals
  • London, United Kingdom
    • St Thomas' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARTO system	Device: ARTO System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	<=30 days post procedure
Mitral regurgitation grade and change from baseline to 30 days		<=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	procedural

Collaborators and Investigators

• Sponsor: Mvrx, Inc.
• Investigators: Principal Investigator: Andrejs Erglis, MD, Pauls Stradins Clinical University Hospital

Publications and helpful links

General 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.
• Rogers 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimate): November 27, 2014

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: EU010513, AU220816