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

Primary Purpose

Mitral Valve Regurgitation

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ARTO System
Sponsored by
Mvrx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Wesley Hospital
  • St Andrews Hospital
  • Warringal Private Hospital
  • The Mount Hospital
  • ICPS
  • IRCCS San Donato
  • Pauls Stradins Clinical University Hospital
  • Brighton and Sussex University Hospitals
  • St Thomas' Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARTO system

Arm Description

Outcomes

Primary Outcome Measures

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
Mitral regurgitation grade and change from baseline to 30 days
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

Secondary Outcome Measures

Full Information

First Posted
November 18, 2014
Last Updated
April 26, 2021
Sponsor
Mvrx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02302872
Brief Title
Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation
Acronym
MAVERIC
Official Title
Mitral Valve Repair Clinical Trial (MAVERIC Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mvrx, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARTO system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ARTO System
Primary Outcome Measure Information:
Title
Major Adverse Event Rate to 30 Days post-procedure
Description
Major Adverse Events defined as: death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure
Time Frame
<=30 days post procedure
Title
Mitral regurgitation grade and change from baseline to 30 days
Time Frame
<=30 days post procedure
Title
Device Technical Success
Description
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
Time Frame
procedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% 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. Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrejs Erglis, MD
Organizational Affiliation
Pauls Stradins Clinical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Wesley Hospital
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
St Andrews Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Warringal Private Hospital
City
Heidelberg
Country
Australia
Facility Name
The Mount Hospital
City
Perth
Country
Australia
Facility Name
ICPS
City
Massy
Country
France
Facility Name
IRCCS San Donato
City
Milan
Country
Italy
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Brighton and Sussex University Hospitals
City
Brighton
Country
United Kingdom
Facility Name
St Thomas' Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29191334
Citation
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.
Results Reference
derived
PubMed Identifier
26117461
Citation
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.
Results Reference
derived

Learn more about this trial

Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation

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