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Trial record 2 of 8 for:    EVEREST II

Real World Expanded Multicenter Study of the MitraClip® System (REALISM) (REALISM)

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Evalve
ClinicalTrials.gov Identifier:
NCT01931956
First received: August 27, 2013
Last updated: August 12, 2015
Last verified: August 2015
  Purpose
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Clinical follow-up at discharge, 30 days, 6 months, 12 months, and 2-, 3-, 4-, and 5-years. The study consists of two arms: a high risk group and a non-high risk group. Enrollment in high risk arm is ongoing. Enrollment in non-high risk arm concluded in April 2011.

Condition Intervention
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Device: MitraClip® System

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multicenter Study of the MitraClip System (REALISM)

Further study details as provided by Evalve:

Intervention Details:
    Device: MitraClip® System
    Percutaneous mitral valve repair using MitraClip implant
Detailed Description:

The EVEREST II REALISM study (REALISM study) is a continued access registry designed for continued data collection on the use of Abbott Vascular's MitraClip System (MitraClip® Device) under more "real world" conditions. After the completion of enrollment in the pivotal EVEREST II Randomized Controlled Trial (RCT) and EVEREST II High Risk Registry Study, continued access to the technology was warranted to collect additional safety and effectiveness data on the MitraClip® Device. This continued access study was approved by FDA on November 21, 2008 (G030064). There are two arms (High Risk and Non-High Risk) in the REALISM study. Enrollment in the Non-High Risk arm of the study concluded on April 14, 2011 and enrollment in the High Risk arm concluded on December 19, 2013.

REALISM is a prospective, multi-center, study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant). Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation (MR), as determined by the site from a transthoracic echocardiogram (TTE), were considered for enrollment in this study. The TTE and a transesophageal echocardiogram (TEE) are used to assess eligibility criteria for MR severity, valve anatomy and left ventricular parameters.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Criteria

Patients screened in EVEREST II REALISM Study will first be screened for high risk (HR) status and enrolled into the HR arm if they meet eligibility for this arm of the study. If they do not meet eligibility for the HR arm, patients will be further screened for eligibility for enrollment into the non-high risk (NHR) arm of EVEREST II REALISM.

Key Inclusion Criteria

  • Moderate to severe (3+) or severe (4+) chronic mitral valve (MV) regurgitation and:

    1. Symptomatic with > 25% LVEF and LVESD ≤55mm or, 2. Asymptomatic with one or more of the following: i. LVEF 25% to 60% ii. LVESD ≥40 mm iii. New onset of AFib iv. PASP >50mmHg at rest or >60mmHg with exercise.

  • Candidate for MV surgery.
  • The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the MV.
  • Trans-septal catheterization is determined to be feasible by the treating physician.

High Risk Inclusion Criteria (High Risk Arm)

  • Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥ 12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of one of the following indications:

    1. Porcelain aorta or mobile ascending aortic atheroma
    2. Post-radiation mediastinum
    3. Previous mediastinitis
    4. Functional MR with EF<40
    5. Over 75 years old with EF<40
    6. Re-operation with patent grafts
    7. Two or more prior chest surgeries
    8. Hepatic cirrhosis
    9. Three (3) or more of the following STS high risk factors 9.1 Creatinine >2.5 mg/dL 9.2 Prior chest surgery 9.3 Age over 75 9.4 EF<35

Key Exclusion Criteria

  • Evidence of an AMI in the prior 12 weeks of the intended treatment.
  • The need for any other cardiac surgery.
  • Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure.
  • In the judgment of the Investigator, the femoral vein cannot accommodate a 24F catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral DVT is present.
  • Severe LV dysfunction (EF <25% and/or LVESD >55mm).
  • MV orifice area <4.0 cm2.
  • If leaflet flail is present:

    1. Flail Width ≥15 mm, or
    2. Flail Gap ≥10 mm.
  • If leaflet tethering is present:

    1. Vertical coaptation length <2 mm.

  • Severe mitral annular calcification.
  • Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:

    1. Evidence of calcification in the grasping area of the A2 and/or P2 scallops
    2. Presence of a significant cleft of A2 or P2 scallops
    3. More than one anatomic criteria dimensionally near the exclusion limits
    4. Bileaflet flail or severe bileaflet prolapse
    5. Lack of both primary and secondary chordal support
  • Hemodynamic instability (systolic pressure <90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump).
  • Need for emergency surgery for any reason.
  • Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted VAD.
  • Systolic anterior motion of the MV leaflet.
  • Hypertrophic cardiomyopathy.
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  • History of a stroke or documented TIA within the prior 6 months.
  • Upper GI bleeding within the prior 6 months.
  • History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
  • Life expectancy <12 months.
  • Platelet count <75,000 cells/mm³.
  • Creatinine >2.5mg/dL)
  • Active infections requiring current antibiotic therapy.
  • Patients in whom transesophageal echocardiography (TEE) is contraindicated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931956

  Show 38 Study Locations
Sponsors and Collaborators
Evalve
Investigators
Study Director: Ted Feldman, M.D. Feldman, M.D. NorthShore University HealthSystem
Study Director: Donald D Glower Jr., MD Duke University
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Evalve
ClinicalTrials.gov Identifier: NCT01931956     History of Changes
Other Study ID Numbers: 0401B  0401 
Study First Received: August 27, 2013
Last Updated: August 12, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Evalve:
EVEREST
EVEREST I
EVEREST II
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve
MR
Mitral Valve Prolapse
E2E - Edge to Edge
Alfieri Technique
MitraClip
Functional MR
Degenerative MR
Echocardiogram
CAD - Coronary Artery Disease
Heart Failure
Heart Attack
REALISM

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 26, 2016