This study is being conducted to satisfy the post-CE approval requirement.
Study Type
OBSERVATIONAL
Enrollment
122
Aortic or mitral valve replacement
Franciscan Saint Francis Health
Indianapolis, Indiana, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, United States
Number of Deaths, Reinterventions, or Explants
Number of deaths, reinterventions, or explants related to the valve
Time frame: 1-year post implant
Number of Deaths, Reinterventions, or Explants
Number of deaths, reinterventions, or explants related to the valve
Time frame: 3-years post implant
Mean Gradient (mmHg)
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
Peak Gradient (mmHg)
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
Effective Orifice Area (EOA)
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
Effective Orifice Area Index (EOAi)
EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area
Time frame: 1-year post implant
Cardiac Output
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
Cardiac Index
Cardiac Output Measured by echocardiogram via Echo Core Lab/Body Surface Area
Time frame: 1-year post implant
Performance Index
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Deutsches Herzzentrum München Klinik an der TU München
München, Germany
Institute of Cardiology in Warsaw
Warsaw, Poland
The performance index is a measure of how effectively the external dimension of the valve is used to provide forward flow, normalized to the valve size. It is defined as effective orifice area divided by the tissue annulus area, where the tissue annulus area is calculated from the prosthetic valve size.
Time frame: 1-year post implant
Transvalvular Regurgitation
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
Paravalvular Regurgitation
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
Total Regurgitation
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
New York Heart Association (NYHA) Classification
Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Time frame: 1-year post implant
Mean Gradient
Measured by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
Peak Gradient
Measured by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
Effective Orifice Area (EOA)
Measured by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
Effective Orifice Area Index (EOAi)
EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area
Time frame: 3-years post implant
Cardiac Output
Measure by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
Cardiac Index
Cardiac output measured by echocardiogram via Echo Core Lab/Body Surface Area
Time frame: 3-years post implant
Performance Index
The performance index is a measure of how effectively the external dimension of the valve is used to provide forward flow, normalized to the valve size. It is defined as effective orifice area divided by the tissue annulus area, where the tissue annulus area is calculated from the prosthetic valve size.
Time frame: 3-years post implant
Transvalvular Regurgitation
Measured by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
Paravalvular Regurgitation
Measured by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
Total Regurgitation
Measured by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
New York Heart Association (NYHA) Classification
Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Time frame: 3-years post implant