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

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ClinicalTrials.gov Identifier: NCT02302872
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Mvrx, Inc.

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).

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: ARTO System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mitral Valve Repair Clinical Trial (MAVERIC Trial)
Study Start Date : October 2013
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
Experimental: ARTO system Device: ARTO System



Primary Outcome Measures :
  1. 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

  2. Mitral regurgitation grade and change from baseline to 30 days [ Time Frame: <=30 days post procedure ]
  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302872


Contacts
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Contact: Robert Chang +16506782960 rchang@mvrxinc.com
Contact: samantha greene +19499108948

Locations
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Australia, Queensland
The Wesley Hospital Recruiting
Auchenflower, Queensland, Australia, 4066
Contact: Anthony Rafter, MD         
Principal Investigator: Anthony Rafter, MD         
Australia, South Australia
St Andrews Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Stephen Worthley, MD         
France
ICPS Recruiting
Massy, France
Contact: Philippe Garot, MD         
Latvia
Pauls Stradins Clinical University Hospital Recruiting
Riga, Latvia, 1002
Contact: Andrejs Erglis, MD         
United Kingdom
Brighton and Sussex University Hospitals Recruiting
Brighton, United Kingdom
Contact: David Hildick-Smith, MD         
St Thomas' Hospital Recruiting
London, United Kingdom
Contact: Simon Redwood, MD         
Sponsors and Collaborators
Mvrx, Inc.
Investigators
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Principal Investigator: Andrejs Erglis, MD Pauls Stradins Clinical University Hospital