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Mitral Implantation of TRAnscatheter vaLves (MITRAL)

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ClinicalTrials.gov Identifier: NCT02370511
Recruitment Status : Active, not recruiting
First Posted : February 25, 2015
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Henry Ford Hospital
Information provided by (Responsible Party):
Mayra Guerrero, NorthShore University HealthSystem

Brief Summary:
The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification who are not candidates for standard mitral valve surgery.

Condition or disease Intervention/treatment Phase
Mitral Valve Disease Device: Transcatheter Mitral Valve Replacement Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Feasibility of the SAPIEN XTTM Transcatheter Heart Valve With NovaFlex and Ascendra Delivery Systems and SAPIEN 3 With Commander Delivery System in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification and Patients With Failing Mitral Surgical Rings or Bioprostheses Who Are Not Candidates for Mitral Valve Surgery.
Actual Study Start Date : February 25, 2015
Actual Primary Completion Date : December 21, 2017
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Native mitral valve with severe MAC
Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.
Device: Transcatheter Mitral Valve Replacement
Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.

Experimental: Valve-in-Ring
Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).
Device: Transcatheter Mitral Valve Replacement
Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.

Experimental: Valve-in-Valve
Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).
Device: Transcatheter Mitral Valve Replacement
Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.




Primary Outcome Measures :
  1. The primary safety endpoint is technical success at exit from the cath lab and procedural success at 30 days. [ Time Frame: 30 days ]
    • Technical success (at exit from cath lab) is defined as:

      • Successful vascular delivery and retrieval of transcatheter valve delivery system
      • Deployment of single valve
      • Correct position of transcatheter valve
      • Adequate performance of prosthesis (MVA > 1.5 cm2) without residual MR grade ≥2 (+)
      • No need for additional surgery or re-intervention
      • Patient leaves cath lab alive
    • Procedural Success (30 days) is defined as:

      • Device success at 30 days
      • No device/procedure related SAE's

  2. The primary effectiveness endpoint is individual patient success at one year. [ Time Frame: 1 year ]

    The primary effectiveness endpoint is individual patient success at one year.

    • Individual patient success at one year is defined as:

    Device success AND all of the following:

    • The patient returns to the pre-procedural setting
    • No re-hospitalizations or re-interventions for HF or the underlying MV condition (including HF hospitalization or HF hospitalization equivalents, drainage pleural effusions, new listing for heart transplant, VAD or other MCS)
    • NYHA improvement of at least 1 class vs. baseline
    • KCCQ improvement > 10 vs. Baseline
    • 6MWT improvement > 50 meters vs. baseline


Secondary Outcome Measures :
  1. The secondary safety and effectiveness endpoint is a non-hierarchical composite of various adverse events, as well as each individual event listed below. [ Time Frame: 30 days and 1 year ]

    The specific components of the composite are:

    • all stroke and TIA
    • myocardial infarction
    • major vascular complication (MVARC)
    • life-threatening bleeding (MVARC)
    • reoperation or catheter-based intervention for: valve thrombosis, valve displacement, or other valve placed procedure-related complication
    • hemolysis
    • endocarditis
    • moderate or severe central mitral insufficiency ≥ 2 (+), and/or moderate or severe perivalvular leak causing ≥ 2 (+) mitral insufficiency
    • significant mitral stenosis (mean MVG >10 mmHg)
    • permanent pacemaker insertion
    • new aortic valve dysfunction
    • new LVOT gradient ≥ 20 mmHg, or ≥ 20 mmHg increase from baseline LVOT gradient.
    • acute kidney injury (MVARC)



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria in Native Mitral Valve arm

All Candidates must meet the following criteria:

  1. Patient has severe calcific native mitral valve stenosis with mitral annular calcification with echocardiographically derived mitral valve area (MVA) of ≤1.5 cm2, or severe mitral regurgitation with severe mitral annular calcification and at least moderate mitral valve stenosis. Qualifying echo must be within 60 days of the date of the procedure.
  2. Patient is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater, or symptoms during stress test.
  3. The patient is at least 22 years old.
  4. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
  5. The heart team agrees that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the STS score is ≥15% or the probability of death or serious, irreversible morbidity is ≥ 50%. The surgeons' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation of the STS score to additionally identify the risks in the patient (some medical factors and definitions are provided below). At least one of the cardiac surgeon assessors must have physically evaluated the patient. All patients must be approved by the Patient Selection and Procedure Management Steering Committee (at least 2 member votes, one must be a cardiac surgeon).
  6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  7. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.

Inclusion Criteria in Valve-in-Ring arm

All Candidates must meet the following criteria:

  1. Patient has a failing surgical ring in the mitral position with severe mitral regurgitation or stenosis (echocardiographically derived mitral valve area [MVA] of ≤1.5 cm2. Qualifying echo must be within 60 days of the date of the procedure.
  2. Patient is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater, or symptoms during stress test, or severe hemolytic anemia requiring blood transfusions and no other cause of hemolytic anemia is found after extensive work up.

Inclusion Criteria items #3 to 7 will be the same as in Native MV arm described above

Inclusion Criteria in Valve-in-Valve arm

All Candidates must meet the following criteria:

  1. Patient has a failing surgical bioprosthesis in the mitral position with severe mitral regurgitation or stenosis with echocardiographically derived mitral valve area (MVA) of ≤1.5 cm2. Qualifying echo must be within 60 days of the date of the procedure.
  2. Patient is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater, or symptoms during stress test.

Inclusion Criteria items #3 to 7 will be the same as in Native MV arm described above

Exclusion Criteria:

Candidates will be excluded from the study if any of the following conditions are present:

  1. Heart Team assessment of operability (the heart team considers the patient is a surgical candidate).
  2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
  3. Mitral annulus is not calcified (only applies to patients included in Native MV arm).
  4. Complex untreated coronary artery disease:

    1. Unprotected left main coronary artery
    2. Syntax score > 32 (in the absence of prior revascularization)
  5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not excluded.
  6. Any patient with a balloon valvuloplasty (BMV) within 30 days of the procedure (unless BMV is a bridge to procedure after a qualifying ECHO).
  7. Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation.
  8. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL).
  9. Hypertrophic obstructive cardiomyopathy (HOCM).
  10. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
  11. Need for emergency surgery for any reason.
  12. Severe ventricular dysfunction with LVEF < 20%.
  13. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  14. Active upper GI bleeding within 3 months (90 days) prior to procedure.
  15. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
  16. For patients enrolled in the Native MV arm: Native mitral annulus size < 275 mm2 or > 680 mm2 as measured by CT scan.

    For patients in Valve-in-Ring arm: surgical ring with a true mean internal diameter ≤18 mm or ≥ 29 mm or an area < 275 mm2 or > 680 mm2 as measured by CT scan. Caution recommended in:

    • Incomplete bands due to risk of paravalvular leak and risk of LVOT obstruction. Careful measurements by CT and CT-guided procedural planning is recommended.
    • Non-circular rigid or semi-flexible rings (e.g., D-shaped, saddle shaped, etc) due to risk of para-valvular leak and/or out of round or incomplete valve expansion.

    For patients in Valve-in-Valve arm: surgical bioprosthesis with a true internal diameter ≤18 mm or ≥ 29 mm

  17. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
  18. Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.
  19. Expectation that patient will not improve despite treatment of mitral stenosis
  20. Active bacterial endocarditis within 6 months (180 days) of 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): NCT02370511


Locations
United States, Arizona
Banner University Medical Center
Phoenix, Arizona, United States, 85006
United States, California
Cedars-Sinai Medica Center
Los Angeles, California, United States, 90048
United States, District of Columbia
MedStar Washington Medical Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Piedmont HealtCare
Atlanta, Georgia, United States, 30309
United States, Illinois
Evanston Hospital / North Shore University HealthSystem
Evanston, Illinois, United States, 60201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
United States, Texas
Memorial Hermann Texas Medical Center
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 48107
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Mayra Guerrero
Henry Ford Hospital
Investigators
Principal Investigator: Mayra E. Guerrero, MD NorthShore University HealthSystem Research Institute

Publications:

Responsible Party: Mayra Guerrero, Director, Cardiac Structural Interventions, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT02370511     History of Changes
Other Study ID Numbers: EH15-136
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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