A Study of the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients with Aortic Stenosis

Overview

About this study

The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients who have  severe, symptomatic aortic stenosis and are at low operative risk for standard aortic valve replacement.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • 65 years of age or older at time of consent
  • Symptomatic, severe, calcific aortic stenosis with the following TTE criteria
    • Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg AND
    • AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2
  • Aortic valve annulus 273 mm2 - 683 mm2 measured by 3D imaging (CT, TEE or MRI)
  • Adequate iliofemoral access with minimum average vessel diameter of 5.5mm (20, 23, 26mm) and 6.0mm (29mm) and acceptable level of vessel calcification and tortuosity for safe device implant
  • NYHA Functional Class ≥ II
  • Heart team agrees the patient has a risk of operative mortality < 2% (e.g., STS < 4)
  • 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

Exclusion Criteria

  • ≥ 1/4 frailty (Only 0/4 frail patients may be enrolled in the trial)
  • Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia
    • Any one of the following criteria meets the diagnosis for MI
      • Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin (cTn)) with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following
        • Symptoms of ischemia
        • New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB)
        • Development of pathological Q waves in the ECG
        • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
        • Identification of an intracoronary thrombus by angiography
  • Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
  • Severe aortic regurgitation (>3+)
  • Severe mitral regurgitation (>3+)
  • Pre-existing mechanical or bioprosthetic valve in any position. (Of note, mitral ring is not an exclusion)
  • A balloon valvuloplasty within 30 days of the valve implant procedure (unless BAV is a bridge to procedure after a qualifying ECHO)
  • Any therapeutic invasive cardiac procedure performed within 30 days of the valve implant procedure
    • Pre-planned PCI performed within 2 weeks prior to valve procedure or implantation of a permanent pacemaker or Implantable Cardioverter Defibrillator (ICD) is not considered exclusionary criteria.
  • Complex coronary artery disease:
    • Unprotected left main coronary artery
    • Syntax score > 32 (in the absence of prior revascularization)
  • Non-complex, flow limiting coronary artery disease requiring revascularization that cannot be treated at the time of or within 2 weeks prior to the valve procedure
  • A planned concomitant surgical or transcatheter ablation for atrial fibrillation
  • Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL)
  • Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit.
  • Emergency interventional/surgical procedures within 30 days of the valve implant procedure
  • Any planned surgical or peripheral procedure to be performed within the 30 day follow-up from the valve implant procedure
  • Hypertrophic cardiomyopathy with or without obstruction (HOCM)
  • Ventricular dysfunction with LVEF < 45%
  • Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation
  • History of upper GI bleeding within 90 days of the valve implant procedure
  • Inability to tolerate anti-thrombotic/anticoagulation therapy during or after the valve implant procedure
  • Stroke or transient ischemic attack (TIA) within 180 days of the valve implant procedure
  • Renal insufficiency (eGFR < 40 ml/min per the Cock-croft-Gault formula) and/or renal replacement therapy at the time of screening
  • Active bacterial endocarditis within 180 days of the valve implant procedure
  • Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen
  • Chronic liver disease (MELD Score ≥ 10 or Child-Pugh Class B or C)
  • Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (>5mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta
  • Porcelain aorta
  • Complications with prior cardiac surgery (i.e., mediastinitis, prolonged intubation)
  • Refuses blood products
  • Severe chest deformity (i.e., pectus excavatum, mastectomy, iatrogenic radiation exposure)
  • BMI > 50 kg/m2
  • Estimated life expectancy < 24 months
  • Known blood dyscrasia
  • Aortic coarctation
  • Absolute contraindications or allergy to iodinated contrast that cannot be pre-medicated
  • Immobility that would prevent completion of study procedures
  • Currently participating in an investigational drug or another device study
    • Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials
    • Observational studies are not considered exclusionary
  • Refuses SAVR

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Holmes, M.D.

Closed for enrollment

Contact information:

Pamela Roessler R.N.

(507) 266-4044

Roessler.Pamela@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20258283

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