Heart Valve Diseases
Conditions
Brief summary
This study is being conducted to satisfy the post-CE approval requirement.
Interventions
DEVICEMosaic model 305, model 310, and ultra model 305
Aortic or mitral valve replacement
Sponsors
Medtronic Cardiac Surgery
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Subjects who require aortic or mitral valve replacement of their native valve. 2. Subject is geographically stable and willing to return to the implanting site for all follow-up visits. 3. Subject is of legal age to provide informed consent in the country where they enroll in the study. 4. Subject has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation in the clinical study.
Exclusion criteria
1. Subject requires concomitant replacement of the aortic and mitral valves. 2. Subject requires a replacement of a previously implanted prosthetic aortic or mitral valve. 3. Subject requires a Bentall procedure for replacement of aortic valve or aortic root.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Deaths, Reinterventions, or Explants | 1-year post implant | Number of deaths, reinterventions, or explants related to the valve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Gradient (mmHg) | 1-year post implant | Measured by echocardiogram via Echo Core Lab |
| Peak Gradient (mmHg) | 1-year post implant | Measured by echocardiogram via Echo Core Lab |
| Effective Orifice Area (EOA) | 1-year post implant | Measured by echocardiogram via Echo Core Lab |
| Effective Orifice Area Index (EOAi) | 1-year post implant | EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area |
| Cardiac Output | 1-year post implant | Measured by echocardiogram via Echo Core Lab |
| Cardiac Index | 1-year post implant | Cardiac Output Measured by echocardiogram via Echo Core Lab/Body Surface Area |
| Performance Index | 1-year post implant | 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. |
| Transvalvular Regurgitation | 1-year post implant | Measured by echocardiogram via Echo Core Lab |
| Paravalvular Regurgitation | 1-year post implant | Measured by echocardiogram via Echo Core Lab |
| Total Regurgitation | 1-year post implant | Measured by echocardiogram via Echo Core Lab |
| New York Heart Association (NYHA) Classification | 1-year post implant | 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. |
| Mean Gradient | 3-years post implant | Measured by echocardiogram via Echo Core Lab |
| Peak Gradient | 3-years post implant | Measured by echocardiogram via Echo Core Lab |
Countries
Germany, Poland, United States
Participant flow
Recruitment details
122 subject were consented to participate. 22 were withdrawn from the study prior to study device implant.
Participants by arm
| Arm | Count |
|---|---|
| Aortic Valve Replacements Subjects requiring aortic valve replacement | 89 |
| Mitral Valve Replacements Subjects requiring mitral valve replacement | 11 |
| Total | 100 |
Baseline characteristics
| Characteristic | Total | Mitral Valve Replacements | Aortic Valve Replacements |
|---|---|---|---|
| Age, Continuous | 69.6 Years STANDARD_DEVIATION 7.8 | 69.1 Years STANDARD_DEVIATION 8.2 | 69.6 Years STANDARD_DEVIATION 7.8 |
| Body Mass Index | 31.0 kg/m^2 STANDARD_DEVIATION 6.5 | 30.6 kg/m^2 STANDARD_DEVIATION 9.8 | 31.0 kg/m^2 STANDARD_DEVIATION 6.1 |
| Body Surface Area | 2.1 m^2 STANDARD_DEVIATION 0.3 | 2.0 m^2 STANDARD_DEVIATION 0.3 | 2.1 m^2 STANDARD_DEVIATION 0.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants | 10 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 0 Participants | 14 Participants |
| Height | 170.4 cm STANDARD_DEVIATION 9.6 | 170.9 cm STANDARD_DEVIATION 9.2 | 170.3 cm STANDARD_DEVIATION 9.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 0 Participants | 14 Participants |
| Race (NIH/OMB) White | 83 Participants | 10 Participants | 73 Participants |
| Region of Enrollment Germany | 14 participants | 0 participants | 14 participants |
| Region of Enrollment Poland | 20 participants | 0 participants | 20 participants |
| Region of Enrollment United States | 66 participants | 11 participants | 55 participants |
| Sex: Female, Male Female | 34 Participants | 4 Participants | 30 Participants |
| Sex: Female, Male Male | 66 Participants | 7 Participants | 59 Participants |
| Weight | 90.0 kg STANDARD_DEVIATION 19.9 | 88.2 kg STANDARD_DEVIATION 24.5 | 90.2 kg STANDARD_DEVIATION 19.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 89 | 1 / 11 |
| other Total, other adverse events | 52 / 89 | 11 / 11 |
| serious Total, serious adverse events | 55 / 89 | 7 / 11 |
Outcome results
Primary
Number of Deaths, Reinterventions, or Explants
Number of deaths, reinterventions, or explants related to the valve
Time frame: 3-years post implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve Replacements | Number of Deaths, Reinterventions, or Explants | 2 Participants |
| Mitral Valve Replacements | Number of Deaths, Reinterventions, or Explants | 0 Participants |
Primary
Number of Deaths, Reinterventions, or Explants
Number of deaths, reinterventions, or explants related to the valve
Time frame: 1-year post implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve Replacements | Number of Deaths, Reinterventions, or Explants | 2 Participants |
| Mitral Valve Replacements | Number of Deaths, Reinterventions, or Explants | 0 Participants |
Secondary
Cardiac Index
Cardiac Output Measured by echocardiogram via Echo Core Lab/Body Surface Area
Time frame: 1-year post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Cardiac Index | 2.4 L/min/m^2 | Standard Deviation 0.5 |
| Mitral Valve Replacements | Cardiac Index | 2.1 L/min/m^2 | Standard Deviation 0.4 |
Secondary
Cardiac Index
Cardiac output measured by echocardiogram via Echo Core Lab/Body Surface Area
Time frame: 3-years post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Cardiac Index | 2.4 L/min/m^2 | Standard Deviation 0.5 |
| Mitral Valve Replacements | Cardiac Index | 1.8 L/min/m^2 | Standard Deviation 0.3 |
Secondary
Cardiac Output
Measure by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Cardiac Output | 4.7 L/min | Standard Deviation 1 |
| Mitral Valve Replacements | Cardiac Output | 3.6 L/min | Standard Deviation 0.7 |
Secondary
Cardiac Output
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Cardiac Output | 4.7 L/min | Standard Deviation 1.1 |
| Mitral Valve Replacements | Cardiac Output | 4.1 L/min | Standard Deviation 1.2 |
Secondary
Effective Orifice Area (EOA)
Measured by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Effective Orifice Area (EOA) | 1.41 cm^2 | Standard Deviation 0.32 |
| Mitral Valve Replacements | Effective Orifice Area (EOA) | 1.26 cm^2 | Standard Deviation 0.47 |
Secondary
Effective Orifice Area (EOA)
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Effective Orifice Area (EOA) | 1.41 cm^2 | Standard Deviation 0.37 |
| Mitral Valve Replacements | Effective Orifice Area (EOA) | 1.35 cm^2 | Standard Deviation 0.43 |
Secondary
Effective Orifice Area Index (EOAi)
EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area
Time frame: 1-year post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Effective Orifice Area Index (EOAi) | 0.71 cm^2/m^2 | Standard Deviation 0.18 |
| Mitral Valve Replacements | Effective Orifice Area Index (EOAi) | 0.70 cm^2/m^2 | Standard Deviation 0.24 |
Secondary
Effective Orifice Area Index (EOAi)
EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area
Time frame: 3-years post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Effective Orifice Area Index (EOAi) | 0.71 cm^2/m^2 | Standard Deviation 0.14 |
| Mitral Valve Replacements | Effective Orifice Area Index (EOAi) | 0.63 cm^2/m^2 | Standard Deviation 0.22 |
Secondary
Mean Gradient
Measured by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Mean Gradient | 14.3 mmHg | Standard Deviation 4.4 |
| Mitral Valve Replacements | Mean Gradient | 5.0 mmHg | Standard Deviation 1.3 |
Secondary
Mean Gradient (mmHg)
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Mean Gradient (mmHg) | 14.3 mmHg | Standard Deviation 5.1 |
| Mitral Valve Replacements | Mean Gradient (mmHg) | 4.6 mmHg | Standard Deviation 1.8 |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Replacements | New York Heart Association (NYHA) Classification | NYHA I | 51 Participants |
| Aortic Valve Replacements | New York Heart Association (NYHA) Classification | NYHA II | 21 Participants |
| Aortic Valve Replacements | New York Heart Association (NYHA) Classification | NYHA III | 3 Participants |
| Aortic Valve Replacements | New York Heart Association (NYHA) Classification | NYHA IV | 0 Participants |
| Mitral Valve Replacements | New York Heart Association (NYHA) Classification | NYHA IV | 0 Participants |
| Mitral Valve Replacements | New York Heart Association (NYHA) Classification | NYHA I | 8 Participants |
| Mitral Valve Replacements | New York Heart Association (NYHA) Classification | NYHA III | 0 Participants |
| Mitral Valve Replacements | New York Heart Association (NYHA) Classification | NYHA II | 2 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Replacements | New York Heart Association (NYHA) Classification | NYHA I | 51 Participants |
| Aortic Valve Replacements | New York Heart Association (NYHA) Classification | NYHA II | 14 Participants |
| Aortic Valve Replacements | New York Heart Association (NYHA) Classification | NYHA III | 1 Participants |
| Aortic Valve Replacements | New York Heart Association (NYHA) Classification | NYHA IV | 0 Participants |
| Mitral Valve Replacements | New York Heart Association (NYHA) Classification | NYHA IV | 0 Participants |
| Mitral Valve Replacements | New York Heart Association (NYHA) Classification | NYHA I | 7 Participants |
| Mitral Valve Replacements | New York Heart Association (NYHA) Classification | NYHA III | 1 Participants |
| Mitral Valve Replacements | New York Heart Association (NYHA) Classification | NYHA II | 1 Participants |
Secondary
Paravalvular Regurgitation
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Replacements | Paravalvular Regurgitation | Mild | 6 Participants |
| Aortic Valve Replacements | Paravalvular Regurgitation | Moderate to Severe | 0 Participants |
| Aortic Valve Replacements | Paravalvular Regurgitation | Trace | 1 Participants |
| Aortic Valve Replacements | Paravalvular Regurgitation | Severe | 0 Participants |
| Aortic Valve Replacements | Paravalvular Regurgitation | Moderate | 3 Participants |
| Aortic Valve Replacements | Paravalvular Regurgitation | Not recorded/unable to assess | 7 Participants |
| Aortic Valve Replacements | Paravalvular Regurgitation | None | 64 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | Not recorded/unable to assess | 1 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | None | 9 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | Trace | 0 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | Mild | 0 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | Moderate | 0 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | Moderate to Severe | 0 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | Severe | 0 Participants |
Secondary
Paravalvular Regurgitation
Measured by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Replacements | Paravalvular Regurgitation | Mild | 4 Participants |
| Aortic Valve Replacements | Paravalvular Regurgitation | Moderate to Severe | 0 Participants |
| Aortic Valve Replacements | Paravalvular Regurgitation | Trace | 1 Participants |
| Aortic Valve Replacements | Paravalvular Regurgitation | Severe | 0 Participants |
| Aortic Valve Replacements | Paravalvular Regurgitation | Moderate | 1 Participants |
| Aortic Valve Replacements | Paravalvular Regurgitation | Not recorded/Unable to assess | 7 Participants |
| Aortic Valve Replacements | Paravalvular Regurgitation | None | 46 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | Not recorded/Unable to assess | 0 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | None | 9 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | Trace | 0 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | Mild | 0 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | Moderate | 0 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | Moderate to Severe | 0 Participants |
| Mitral Valve Replacements | Paravalvular Regurgitation | Severe | 0 Participants |
Secondary
Peak Gradient
Measured by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Peak Gradient | 26.5 mmHg | Standard Deviation 8.3 |
| Mitral Valve Replacements | Peak Gradient | 11.3 mmHg | Standard Deviation 3.4 |
Secondary
Peak Gradient (mmHg)
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Peak Gradient (mmHg) | 25.6 mmHg | Standard Deviation 9.2 |
| Mitral Valve Replacements | Peak Gradient (mmHg) | 11.2 mmHg | Standard Deviation 4.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Performance Index | 0.4 Units do not exist | Standard Deviation 0.1 |
| Mitral Valve Replacements | Performance Index | 0.2 Units do not exist | Standard Deviation 0.1 |
Secondary
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: 1-year post implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve Replacements | Performance Index | 0.4 Units do not exist | Standard Deviation 0.1 |
| Mitral Valve Replacements | Performance Index | 0.2 Units do not exist | Standard Deviation 0.1 |
Secondary
Total Regurgitation
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Replacements | Total Regurgitation | None | 58 Participants |
| Aortic Valve Replacements | Total Regurgitation | Moderate | 3 Participants |
| Aortic Valve Replacements | Total Regurgitation | Mild | 9 Participants |
| Aortic Valve Replacements | Total Regurgitation | Moderate to Severe | 0 Participants |
| Aortic Valve Replacements | Total Regurgitation | Severe | 0 Participants |
| Aortic Valve Replacements | Total Regurgitation | Not recorded/unable to assess | 4 Participants |
| Aortic Valve Replacements | Total Regurgitation | Trace | 7 Participants |
| Mitral Valve Replacements | Total Regurgitation | Not recorded/unable to assess | 1 Participants |
| Mitral Valve Replacements | Total Regurgitation | None | 6 Participants |
| Mitral Valve Replacements | Total Regurgitation | Trace | 2 Participants |
| Mitral Valve Replacements | Total Regurgitation | Severe | 0 Participants |
| Mitral Valve Replacements | Total Regurgitation | Moderate | 0 Participants |
| Mitral Valve Replacements | Total Regurgitation | Moderate to Severe | 0 Participants |
| Mitral Valve Replacements | Total Regurgitation | Mild | 1 Participants |
Secondary
Total Regurgitation
Measured by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Replacements | Total Regurgitation | Moderate to Severe | 2 Participants |
| Aortic Valve Replacements | Total Regurgitation | None | 44 Participants |
| Aortic Valve Replacements | Total Regurgitation | Mild | 6 Participants |
| Aortic Valve Replacements | Total Regurgitation | Severe | 0 Participants |
| Aortic Valve Replacements | Total Regurgitation | Trace | 3 Participants |
| Aortic Valve Replacements | Total Regurgitation | Not recorded/Unable to assess | 3 Participants |
| Aortic Valve Replacements | Total Regurgitation | Moderate | 1 Participants |
| Mitral Valve Replacements | Total Regurgitation | Not recorded/Unable to assess | 0 Participants |
| Mitral Valve Replacements | Total Regurgitation | Trace | 4 Participants |
| Mitral Valve Replacements | Total Regurgitation | Mild | 1 Participants |
| Mitral Valve Replacements | Total Regurgitation | Moderate to Severe | 0 Participants |
| Mitral Valve Replacements | Total Regurgitation | None | 4 Participants |
| Mitral Valve Replacements | Total Regurgitation | Severe | 0 Participants |
| Mitral Valve Replacements | Total Regurgitation | Moderate | 0 Participants |
Secondary
Transvalvular Regurgitation
Measured by echocardiogram via Echo Core Lab
Time frame: 3-years post implant
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Replacements | Transvalvular Regurgitation | Mild | 1 Participants |
| Aortic Valve Replacements | Transvalvular Regurgitation | Moderate to Severe | 0 Participants |
| Aortic Valve Replacements | Transvalvular Regurgitation | Trace | 1 Participants |
| Aortic Valve Replacements | Transvalvular Regurgitation | Severe | 0 Participants |
| Aortic Valve Replacements | Transvalvular Regurgitation | Moderate | 0 Participants |
| Aortic Valve Replacements | Transvalvular Regurgitation | Not recorded/unable to assess | 7 Participants |
| Aortic Valve Replacements | Transvalvular Regurgitation | None | 50 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | Not recorded/unable to assess | 0 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | None | 4 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | Trace | 4 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | Mild | 1 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | Moderate | 0 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | Moderate to Severe | 0 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | Severe | 0 Participants |
Secondary
Transvalvular Regurgitation
Measured by echocardiogram via Echo Core Lab
Time frame: 1-year post implant
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve Replacements | Transvalvular Regurgitation | Mild | 1 Participants |
| Aortic Valve Replacements | Transvalvular Regurgitation | Moderate to Severe | 0 Participants |
| Aortic Valve Replacements | Transvalvular Regurgitation | Trace | 6 Participants |
| Aortic Valve Replacements | Transvalvular Regurgitation | Severe | 0 Participants |
| Aortic Valve Replacements | Transvalvular Regurgitation | Moderate | 0 Participants |
| Aortic Valve Replacements | Transvalvular Regurgitation | Not recorded/unable to assess | 7 Participants |
| Aortic Valve Replacements | Transvalvular Regurgitation | None | 67 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | Not recorded/unable to assess | 0 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | None | 7 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | Trace | 2 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | Mild | 1 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | Moderate | 0 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | Moderate to Severe | 0 Participants |
| Mitral Valve Replacements | Transvalvular Regurgitation | Severe | 0 Participants |