A Study of the Evalve Cardiovascular Valve Repair System (CVRS)Endovascular Valve Edge-to-Edge REpair Study II (EVEREST II) Protocol # 401 Continued Access Registry

Study Status

Open to Enrollment

Study Description

The purpose of the study is to continue evaluation and monitoring of the safety and effectiveness of an investigational device that repairs the mitral valve. The device is called the MitraClip® System.   It consists of a delivery catheter and an implantable Clip to repair the mitral valve. The delivery catheter guides the Clip into place so that it can be attached to the leaflets of the mitral valve.

Sponsor

Evalve, Inc.

Key Eligibility

  • Men and women age 18 and older
  • Women must not be pregnant (confirmed 7 days prior to procedure)
  • Moderate to severe (3+) or severe (4+) chronic mitral valve regurgitation and:
    • Symptomatic with > 25% LVEF and LVESD ≤ 55mm or,
    • Asymptomatic with one or more of the following:
      • LVEF 25% to 60%
      • LVESD ≥ 40 mm
      • New onset of atrial fibrillation
      • Pulmonary hypertension defined as pulmonary artery systolic pressure (PASP) > 50mmHg at rest or > 60mmHg with exercise
  • Candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass
  • The primary regurgitant jet orginates from malcoaptation of the A2 and P2 scallops of the mitral valve. If a secondary jet exists, it must be considered clinically insignificant
  • The patient and physician agree that the patient will return for all required follow-up visits following the procedure
  • Trans-septal catheritization is determined to be feasible by the treating physician

Principal Investigator

S. Chiu Wong, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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