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ECHONOMY
Tools for Echocardiographic Calculations
Muhamed Saric, MD, PhD
New York University
 

COAPT Trial

Inclusion Criteria
  1. Moderate to Severe or Severe MR - Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or nonischemic etiology determined by assessment of a TTE obtained within 2 months prior to enrollment, with MR severity and MR etiology confirmed by the Echocardiography Core Lab. Note: The TTE must be obtained after the subject has been stabilized on optimal medical therapy (see Appendix A: Definitions) and has undergone revascularization and/or CRT, as appropriate.
     
  2. On Optimal Medical Therapy - In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards, such as for coronary artery disease, left ventricular dysfunction, mitral regurgitation or heart failure (e.g., cardiac resynchronization therapy, revascularization, optimal therapy; see APPENDIX A: Definitions). Note: Subjects with LVEF of less than or equal to 35%, sinus rhythm, and NYHA functional class III or ambulatory class IV symptoms despite recommended optimal medical therapy and who have cardiac dyssynchrony, which is currently defined as a QRS duration greater than or equal to 0.12 seconds, may not be enrolled unless he/she has received cardiac resynchronization therapy, with or without an ICD, unless contraindicated.
     
  3. Symptomatic - New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
     
  4. Not a Candidate for Mitral Valve Surgery  - The subject is not a suitable candidate for open mitral valve surgery due to comorbidities such that the calculated STS mortality risk is ≥ 8%, or the Local Site Heart Team concludes that co-morbidities result in a prohibitive predicted operative risk of stroke or death. A candidate who does not meet the STS mortality risk criterion of ≥ 8% can be included in the trial if the Local Site Heart Team and the Central Eligibility Committee concur and document that the subject’s predicted operative risk of stroke or death is prohibitive for open mitral valve surgery for reasons not captured by the STS risk calculator. The local site surgeon's assessment of operative co-morbidities not captured by the STS risk calculator must be documented in the case report form as well as in the subject’s medical record.
     
  5. Hospitalized for Heart Failure - The subject has had at least one hospitalization for heart failure in the 12 months prior to enrollment and/or BNP ≥400 pg/ml or nT-proBNP ≥1600 pg/ml measured within 90 days prior to enrollment.
     
  6. A2/P2 Originin of MR Jet - The predominant primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve. If a secondary jet exists, it must be considered clinically insignificant. The Echocardiography Core Lab will confirm these findings prior to enrollment.
     
  7. Transseptal catheterization and femoral vein access is determined to be feasible.
     
  8. Age 18 years or older.
     
  9. The subject or the subject’s legal representative understands and agrees that should he/she be assigned to the Control group, he/she will be treated with medical therapy and conservative management without surgery and without the MitraClip, either domestically or abroad. If the subject would actively contemplate surgery and/or MitraClip if randomized to Control, he/she should not be enrolled in this trial.
     
  10. The subject or the subject’s legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent.
     

Exclusion Criteria

  1. LVEF < 20% or LVESD > 55 mm - The subject has severe LV dysfunction based on an echocardiogram obtained within 6 months prior to enrollment (severe LV dysfunction is defined as Left Ventricular End Systolic Dimension (LVESD) >55 mm or Left Ventricular Ejection Fraction (LVEF) <20%). Note: LVEF must be assessed within 2 months prior to enrollment by a quantitative technique (i.e. MRI, cineangiography, sestamibi blood pool imaging, echocardiography).
     

  2. Evidence of an acute myocardial infarction in 30 days prior to enrollment.
     

  3. Untreated clinically significant coronary artery disease requiring revascularization or tricuspid or aortic valve disease requiring surgery.
     

  4. Cerebrovascular accident within 6 months prior to enrollment or severe symptomatic carotid stenosis (> 70% by ultrasound).
     

  5. ACC/AHA Stage D heart failure.
     

  6. Severe Pulmonary Hypertension or Nondilated Cardiomyopathy - Presence of any of the following:
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    Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by echocardiography or right heart catheterization

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    Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than than dilated cardiomyopathy of either ischemic or non-ischemic etiology

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    Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)

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    Hemodynamic instability requiring inotropic support or mechanical heart assistance
     

  7. Severe right ventricular failure or severe tricuspid regurgitation.
     

  8. Any percutaneous cardiac intervention or carotid surgery within the 30 days prior to enrollment, or any cardiac surgery within the 6 months prior to enrollment.
     

  9. Implant of any rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D), or Implantable Cardioverter Defibrillator (ICD)) within the last 90 days to enrollment, or revision of any implanted rhythm management device within the last 90 days to enrollment.
     

  10. Mitral Stenosis - Mitral valve orifice area < 4.0 cm2
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  11. Short Coaptation Length - If leaflet tethering is present, vertical coaptation length is less than 2 mm.
     

  12. Unfavorable Mitral Anatomy - Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR. This may include:
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    Evidence of calcification in the grasping area

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    Presence of a significant cleft in the grasping area

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    Lack of both primary and secondary chordal support in the grasping area

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    Severely restricted leaflet mobility
     

  13. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
     

  14. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
     

  15. Life expectancy < 12 months due to non-cardiac conditions.
     

  16. Modified Rankin Scale ≥ 4 disability.
     

  17. Status 1 heart transplant or prior orthotopic heart transplantation.
     

  18. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
     

  19. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
     

  20. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated).
     

  21. Active infections requiring current antibiotic therapy.
     

  22. Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk.
     

  23. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
     

  24. Pregnant or planning pregnancy within next 12 months.
     

  25. Currently participating in an investigational drug or another device study that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.