Summary

for people ages 18 years and up (full criteria)
at Brighton, and other locations
study started
estimated completion

Description

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).

Official Title

Mitral Valve Repair Clinical Trial (MAVERIC Trial)

Keywords

Mitral Valve Regurgitation Mitral Valve Insufficiency ARTO System

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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

Locations

  • Brighton and Sussex University Hospitals accepting new patients
    Brighton United Kingdom
  • St Thomas' Hospital accepting new patients
    London United Kingdom

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mvrx, Inc.
Links
Sign up for this study
ID
NCT02302872
Study Type
Interventional
Last Updated