Ensayos clínicos

Inclusion Criteria:

• Patient is ≥ eighteen (18) years of age.
• Patient is willing and capable of participating in all testing, assessments and follow-up clinic visits required in this clinical study.
• Femoral vein access and transseptal catheterization are feasible with the CardioMech MVRS guide catheter as determined by the investigator.
• Patient is symptomatic (NYHA class II, III or ambulatory IV).
• Patient is intermediate or high-risk for surgical mitral valve repair (one or more of the following criteria must be present):
  • Age ≥ 75 years; if younger than 75 years, then the patient must have:
    • STS PROM repair score of ≥ 2%; OR
    • Presence of specific severe comorbidities as determined by the local heart team that poses increased peri-operative risk.
      • Note: Eligible patients will be further classified as high-risk for surgical mitral valve repair if any of the following criteria are present:
  • Age ≥ 80 years; of younger than 80 years, then the patient must have:
    • STS PROM repair score of ≥ 6%; OR
    • Presence of specific severe comorbidities as determined by the local heart team that poses greatly increased peri-operative risk.

Inclusion Criteria - Mitral Valve:

• Patient has moderate to severe (≥ 3+) or severe (≥ 4+) mitral valve regurgitation due to mitral valve prolapse or flail of the P2 segment and has mitral valve anatomy and physiology that is suitable for the proposed procedure as determined by the investigator, multi-disciplinary heart team, Core Laboratory and Screening Eligibility Committee.
• Patient has anticipated leaflet coaptation that is acceptable for CardioMech MVRS implant as assessed by the investigator, Subject Eligibility Committee, and Core Laboratory.

Exclusion Criteria:

• Women who are pregnant, lactating, or planning to become pregnant during the clinical study. Women of child-bearing potential must have a negative pregnancy test result within two weeks prior to the procedure.
• Patients with comorbidities, illnesses or social conditions that may compromise their ability to comply with any study requirement.
• Patient is currently participating or planning to participate in a study that, in the investigator’s or Screening Eligibility Committee’s opinion, may clinically affect this protocol’s study endpoints.
• Patient or legal guardian is unable or unwilling to give informed consent.

Exclusion Criteria - Previous or Planned Therapies:

• Patient has had any cardiac or non-cardiac surgical or interventional procedure (including CABG, PCI, transcatheter or surgical valve repair or replacement) performed within 30 days prior to the index implant procedure or any planned procedure within the next 12 months.
• Patient has history of prior repair or replacement of the mitral valve, annuloplasty or valvuloplasty or has a left atrial appendage closure device.

Exclusion Criteria - Medical History and Co-Morbidities:

• Patient has known hypersensitivity or contraindications to necessary medications including contrast compounds or components used in the CardioMech MVRS device that cannot be successfully pre-medicated.
• Patient has acute/semi-acute medical conditions such as respiratory distress, pulmonary edema, or myocarditis.
• Patient has history of bleeding diathesis or coagulopathy or an active peptic ulcer or GI bleeding in past 90 days.
• Patient has chronic renal failure with eGFR by the MDRD formula < 30 ml/min or requiring dialysis.
• Patient has acute or active infection requiring oral or intravenous antibiotic therapy, or elevated temperature or white blood cell count that may be due to infection.
• Patient has documented TIA or stroke within 90 days of the planned implant date or any prior stroke with a permanent neurologic deficit or any prior intracranial bleed.
• Patient has had a deep vein thrombosis (DVT) or pulmonary embolism (PE) within 90 days of the planned implant date.
• Patient has severe chronic obstructive pulmonary disease (COPD) either requiring continuous home oxygen or oral corticosteroids.
• Patient with prior mediastinal or left sided radiotherapy.
• Patient has life expectancy less than 12 months per investigator assessment.
• Patient has presence of an inferior vena cava (IVC) filter, a permanent pacemaker/ICD or pacing leads that in the judgment of the investigator or Screening Eligibility Committee would interfere with placement of the test device or the placement of the test device would possibly disrupt the pacemaker leads.

Exclusion Criteria - Cardiac Function:

• Patient is hypotensive defined as systolic pressure < 90 mmHg or the need for inotropic support or mechanical hemodynamic support.
• Patient has ACC Stage D or NYHA class IV b heart failure; e.g. is bed-ridden and unable to ambulate because of heart failure, is inotrope dependent of awaiting LVAD or heart transplant
• Patient has history of rheumatic heart disease.
• Patient has history of prior endocarditis.
• Patient has left ventricular thrombus or left atrial thrombus present on TTE or TEE.
• Patient has severe tricuspid regurgitation or signs of severe RV dysfunction.
• Patient has severe pulmonary hypertension defined as a PA systolic pressure > 70 mmHg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the catheterization lab is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with V wave less than twice the mean of the pulmonary capillary wedge pressure.
• Patient has echocardiographic evidence of intracardiac mass, vegetation, or inflammatory or infectious valve disease.
• Patient has left ventricular ejection fraction (LVEF) ≤ 30%.
• Patient has evidence of acute myocardial infarction in the prior 90 days of the index implant procedure.

Exclusion Criteria - Mitral Valve:

• Patient has severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment.
• Patient has complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on TEE, TTE or CT scan as assessed by the investigator, Core Laboratory or the Screening Eligibility Committee.
• Patient has LV free wall thickness < 1 cm on CT scan in the areas of anticipated LV anchor placement or has abnormal characteristics of the LV free wall as assessed by the Core Laboratory or Screening Eligibility Committee.
• Patient has any other anatomical characteristics not mentioned previously that in the judgment of the investigator, Core Laboratory or Screening Eligibility Committee precludes the subject from participation.