Aortic Stenosis
Conditions
Brief summary
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
Detailed description
This is a prospective, interventional, non-randomized, worldwide, multi-center trial. A maximum of 1300 subjects were to be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial includes male and female patients of legal age to provide informed consent in the country where they enrolled in the trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Subjects are followed out to 5 years, and select sites follow subjects out to 12 years. Enrollment closed on 14Jul2017 for all valve sizes. Enrollment was reopened in Apr2019 for the 29mm valve size at a subset of US and Canadian sites to obtain greater patient numbers required by the FDA to support US commercial approval of this valve size. Enrollment for the 29mm valve size closed on 14Feb2023.
Interventions
DEVICEModel 400 aortic valve bioprosthesis
Sponsors
Medtronic Cardiac Surgery
Medtronic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following: i. Left atrial appendage (LAA) ligation ii. CABG (coronary artery bypass grafting) iii. Patent foramen ovale (PFO) closure iv. Ascending aortic aneurysm or dissection repair not requiring circulatory arrest v. Resection of a sub-aortic membrane not requiring myectomy 2. Patient is geographically stable and willing to return to the implanting site for all follow-up visits 3. Patient is of legal age to provide informed consent in the country where they enroll in the trial 4. Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial
Exclusion criteria
1. Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve 2. Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis 3. Patient presents with active endocarditis, active myocarditis or other systemic infection 4. Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including: * Ascending aortic aneurysm or dissection repair requiring circulatory arrest * Acute Type A aortic dissection * Ventricular aneurysm * Porcelain aorta * Hostile mediastinum * Hypertrophic obstructive cardiomyopathy (HOCM) * Documented pulmonary hypertension (systolic \>60mmHg) 5. Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to: * Child-Pugh Class C liver disease * Terminal cancer * End-stage lung disease 6. Patient has renal failure, defined as dialysis therapy or glomerular filtration rate(GFR)\<30 mL/min/1.73 m2 7. Patient has hyperparathyroidism 8. Patient is participating in another investigational device or drug trial or observational competitive study 9. Patient is pregnant, lactating or planning to become pregnant during the trial period 10. Patient has a documented history of substance (drug or alcohol) abuse 11. Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography 12. Patient has systolic ejection fraction (EF)\<20% as assessed by echocardiography 13. Patient has Grade IV Diastolic Dysfunction 14. Patient has documented bleeding diatheses 15. Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment 16. Patient requires emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | 1 year post-implant | Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The incidence rates will be used to summarize valve-related adverse events and death. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge (up to 30 days), 3-6 months, and 1 year post-implant | At each timepoint, a minimum of 15 participants per valve size evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure. 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. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | Discharge (up to 30 days), 3-6 months, 1 year post-implant | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | Discharge (up to 30 days), 3-6 months, and 1 year post-implant | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | Measured at discharge (up to 30 days), 3-6 months, and 1 year post-implant | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | Discharge (up to 30 days), 3-6 months, and 1 year post-implant | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days), 3-6 months, and 1 year post-implant | A minimum of 15 participants per valve size will have performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days), 3-6 months, and 1 year post-implant | Cardiac output is the amount of blood pumped by the heart per minute. A minimum of 15 participants per valve size were evaluated for this outcome measure by transthoracic echocardiography technique and assessed by an independent core laboratory. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | Discharge (up to 30 days), 3-6 months, and 1 year post-implant | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death Annually Through 5 Years Post-implant | Annually, at years 2, 3, 4, and 5 post-implant | Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. The Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 5 Years Post-implant | Annually, at years 2, 3, 4, and 5 post-implant | At each timepoint, participants were evaluated for change in New York Heart Association (NYHA) functional classification from baseline through 5 years post-procedure. 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. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 5 Years Post-procedure | Annually, at years 2, 3, 4, and 5 post-implant | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 5 Years Post-implant | Annually, at years 2, 3, 4, and 5 post-implant | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 5 Years Post-implant | Annually, at years 2, 3, 4, and 5 post-implant | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 5 Years Post-implant | Annually, at years 2, 3, 4, and 5 post-implant | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 5 Years Post-implant | Annually, at years 2, 3, 4, and 5 post-implant | Performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 5 Years Post-implant | Annually, at years 2, 3, 4, and 5 post-implant | Cardiac output is the amount of blood pumped by the heart per minute, evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 5 Years Post-implant | Annually, at years 2, 3, 4, and 5 post-implant | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area. |
Countries
Canada, France, Germany, Italy, Netherlands, Switzerland, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORJoseph Sabik, MD
University Hospital Cleveland Medical Center (Not a recruiting site)
PRINCIPAL_INVESTIGATORProf. Dr. Robert Johannes Menno Klautz, MD
Leiden University Medical Center
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medtronic Model 400 Avalus Bioprosthetic Aortic Valve Participants implanted with the Medtronic Model 400 Avalus Bioprosthetic Aortic Valve, as indicated for patients who require replacement of their native aortic valve. | 1,132 |
| Total | 1,132 |
Baseline characteristics
| Characteristic | Medtronic Model 400 Avalus Bioprosthetic Aortic Valve |
|---|---|
| Age, Continuous | 70.1 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 638 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 475 Participants |
| New York Heart Association (NYHA) Classification NYHA Class I | 126 Participants |
| New York Heart Association (NYHA) Classification NYHA Class II | 533 Participants |
| New York Heart Association (NYHA) Classification NYHA Class III | 451 Participants |
| New York Heart Association (NYHA) Classification NYHA Class IV | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 476 Participants |
| Race (NIH/OMB) White | 636 Participants |
| Region of Enrollment Canada | 268 participants |
| Region of Enrollment Europe | 475 participants |
| Region of Enrollment United States | 389 participants |
| Sex: Female, Male Female | 278 Participants |
| Sex: Female, Male Male | 854 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 170 / 1,132 |
| other Total, other adverse events | 1,105 / 1,132 |
| serious Total, serious adverse events | 638 / 1,132 |
Outcome results
Primary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.
Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Population: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 1 Year | 2.5 L/min/m^2 | Standard Deviation 0.5 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 3-6 Months | 2.7 L/min/m^2 | Standard Deviation 0.7 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | Discharge (up to 30 days) | 2.9 L/min/m^2 | Standard Deviation 0.7 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 3-6 Months | 2.5 L/min/m^2 | Standard Deviation 0.5 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | Discharge (up to 30 days) | 2.7 L/min/m^2 | Standard Deviation 0.7 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 1 Year | 2.5 L/min/m^2 | Standard Deviation 0.6 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 1 Year | 2.4 L/min/m^2 | Standard Deviation 0.5 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | Discharge (up to 30 days) | 2.6 L/min/m^2 | Standard Deviation 0.7 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 3-6 Months | 2.4 L/min/m^2 | Standard Deviation 0.5 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 3-6 Months | 2.4 L/min/m^2 | Standard Deviation 0.5 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | Discharge (up to 30 days) | 2.5 L/min/m^2 | Standard Deviation 0.6 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 1 Year | 2.4 L/min/m^2 | Standard Deviation 0.6 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 3-6 Months | 2.3 L/min/m^2 | Standard Deviation 0.6 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | Discharge (up to 30 days) | 2.5 L/min/m^2 | Standard Deviation 0.7 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 1 Year | 2.2 L/min/m^2 | Standard Deviation 0.4 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | Discharge (up to 30 days) | 2.4 L/min/m^2 | Standard Deviation 0.6 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 1 Year | 3.0 L/min/m^2 | Standard Deviation 0.8 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 3-6 Months | 2.7 L/min/m^2 | Standard Deviation 0.7 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 1 Year | 2.4 L/min/m^2 | Standard Deviation 0.6 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | 3-6 Months | 2.4 L/min/m^2 | Standard Deviation 0.5 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | Discharge (up to 30 days) | 2.6 L/min/m^2 | Standard Deviation 0.7 |
Primary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant
Cardiac output is the amount of blood pumped by the heart per minute. A minimum of 15 participants per valve size were evaluated for this outcome measure by transthoracic echocardiography technique and assessed by an independent core laboratory.
Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Population: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 5.0 L/min | Standard Deviation 1 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 3-6 Months | 4.6 L/min | Standard Deviation 1.1 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 1 Year | 4.3 L/min | Standard Deviation 1 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 3-6 Months | 4.5 L/min | Standard Deviation 0.9 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 4.9 L/min | Standard Deviation 1.2 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 1 Year | 4.5 L/min | Standard Deviation 1.1 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 5.1 L/min | Standard Deviation 1.3 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 1 Year | 4.7 L/min | Standard Deviation 1.1 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 3-6 Months | 4.8 L/min | Standard Deviation 1 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 5.2 L/min | Standard Deviation 1.2 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 1 Year | 4.9 L/min | Standard Deviation 1.2 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 3-6 Months | 4.9 L/min | Standard Deviation 1.1 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 5.3 L/min | Standard Deviation 1.4 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 1 Year | 4.8 L/min | Standard Deviation 1 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 3-6 Months | 4.9 L/min | Standard Deviation 1.2 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 5.2 L/min | Standard Deviation 1.2 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 1 Year | 6.4 L/min | Standard Deviation 2 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 3-6 Months | 5.8 L/min | Standard Deviation 1.7 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 1 Year | 4.7 L/min | Standard Deviation 1.2 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | 3-6 Months | 4.8 L/min | Standard Deviation 1.1 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 5.1 L/min | Standard Deviation 1.3 |
Primary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Time frame: Discharge (up to 30 days), 3-6 months, 1 year post-implant
Population: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 3-6 Months | 1.22 cm^2 | Standard Deviation 0.27 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 1 Year | 1.09 cm^2 | Standard Deviation 0.23 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | Discharge (up to 30 days) | 1.23 cm^2 | Standard Deviation 0.24 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 3-6 Months | 1.30 cm^2 | Standard Deviation 0.26 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | Discharge (up to 30 days) | 1.35 cm^2 | Standard Deviation 0.3 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 1 Year | 1.26 cm^2 | Standard Deviation 0.25 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | Discharge (up to 30 days) | 1.59 cm^2 | Standard Deviation 0.34 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 3-6 Months | 1.54 cm^2 | Standard Deviation 0.3 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 1 Year | 1.48 cm^2 | Standard Deviation 0.33 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | Discharge (up to 30 days) | 1.68 cm^2 | Standard Deviation 0.37 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 3-6 Months | 1.66 cm^2 | Standard Deviation 0.32 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 1 Year | 1.60 cm^2 | Standard Deviation 0.34 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 1 Year | 1.76 cm^2 | Standard Deviation 0.35 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 3-6 Months | 1.89 cm^2 | Standard Deviation 0.42 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | Discharge (up to 30 days) | 1.88 cm^2 | Standard Deviation 0.42 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 3-6 Months | 2.51 cm^2 | Standard Deviation 0.71 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | Discharge (up to 30 days) | 2.29 cm^2 | Standard Deviation 0.68 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 1 Year | 2.42 cm^2 | Standard Deviation 0.59 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | Discharge (up to 30 days) | 1.60 cm^2 | Standard Deviation 0.4 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 1 Year | 1.50 cm^2 | Standard Deviation 0.38 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | 3-6 Months | 1.57 cm^2 | Standard Deviation 0.39 |
Primary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Population: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 1 Year | 17.1 mmHg | Standard Deviation 5 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 3-6 Months | 15.4 mmHg | Standard Deviation 4.4 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | Discharge (up to 30 days) | 18.2 mmHg | Standard Deviation 6.1 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 3-6 Months | 14.2 mmHg | Standard Deviation 4.6 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | Discharge (up to 30 days) | 15.2 mmHg | Standard Deviation 4.9 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 1 Year | 15.1 mmHg | Standard Deviation 5.3 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 1 Year | 12.3 mmHg | Standard Deviation 4 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | Discharge (up to 30 days) | 12.9 mmHg | Standard Deviation 4.5 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 3-6 Months | 11.7 mmHg | Standard Deviation 3.7 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 3-6 Months | 11.3 mmHg | Standard Deviation 3.7 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | Discharge (up to 30 days) | 12.4 mmHg | Standard Deviation 3.9 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 1 Year | 11.9 mmHg | Standard Deviation 4 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 3-6 Months | 9.6 mmHg | Standard Deviation 3.3 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | Discharge (up to 30 days) | 10.7 mmHg | Standard Deviation 3.8 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 1 Year | 10.1 mmHg | Standard Deviation 3.7 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | Discharge (up to 30 days) | 8.8 mmHg | Standard Deviation 3.5 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 1 Year | 10.2 mmHg | Standard Deviation 3.5 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 3-6 Months | 7.9 mmHg | Standard Deviation 3.6 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 1 Year | 12.7 mmHg | Standard Deviation 4.6 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | 3-6 Months | 11.9 mmHg | Standard Deviation 4.1 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | Discharge (up to 30 days) | 13.1 mmHg | Standard Deviation 4.7 |
Primary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant
A minimum of 15 participants per valve size will have performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Population: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 3-6 Months | 0.5 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 1 Year | 0.5 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.5 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 1 Year | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.5 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 3-6 Months | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 1 Year | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 3-6 Months | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 3-6 Months | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 1 Year | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 3-6 Months | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 1 Year | 0.3 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 3-6 Months | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 1 Year | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 1 Year | 0.4 L/min | Standard Deviation 0.1 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | 3-6 Months | 0.4 L/min | Standard Deviation 0.1 |
Primary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year
At each timepoint, a minimum of 15 participants per valve size evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure. 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: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Population: Difference in the overall number of participants analyzed and of those analyzed at each timepoint is due to classification not assessed, classification was unable to be assessed, or the participant exited the trial before that timepoint. For 29mm participants, difference in total number of participants analyzed was also due to participants who have not yet reached specified timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 2 Classes | 15 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 1 Class | 0 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 1 Class | 21 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 3 Classes | 0 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | No Change | 8 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 1 Class | 16 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 3 Classes | 0 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 1 Class | 0 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | No Change | 12 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | No Change | 5 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 2 Classes | 13 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 1 Class | 20 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 3 Classes | 0 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 1 Class | 0 Participants |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 2 Classes | 5 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | No Change | 47 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 1 Class | 15 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 2 Classes | 1 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 2 Classes | 14 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 1 Class | 83 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 1 Class | 5 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 3 Classes | 1 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 1 Class | 97 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 2 Classes | 60 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | No Change | 47 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 3 Classes | 0 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 1 Class | 2 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | No Change | 61 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 3 Classes | 1 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 2 Classes | 51 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 1 Class | 83 Participants |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 2 Classes | 105 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 1 Class | 187 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 2 Classes | 2 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 3 Classes | 4 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 3 Classes | 6 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | No Change | 76 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | No Change | 118 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 1 Class | 9 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 1 Class | 6 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | No Change | 76 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 2 Classes | 103 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 1 Class | 131 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 3 Classes | 5 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 1 Class | 176 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 2 Classes | 30 Participants |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 1 Class | 16 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 1 Class | 6 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 3 Classes | 6 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 1 Class | 161 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 2 Classes | 1 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 3 Classes | 2 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | No Change | 116 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 1 Class | 164 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 2 Classes | 82 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 1 Class | 18 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | No Change | 70 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | No Change | 79 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 3 Classes | 6 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 2 Classes | 79 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 1 Class | 5 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 1 Class | 108 Participants |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 2 Classes | 27 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | No Change | 25 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 1 Class | 10 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | No Change | 23 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 2 Classes | 9 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 1 Class | 26 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 1 Class | 43 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 1 Class | 1 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 3 Classes | 0 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 3 Classes | 2 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 3 Classes | 1 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 2 Classes | 27 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | No Change | 26 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 1 Class | 40 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 2 Classes | 27 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 1 Class | 0 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 2 Classes | 4 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | No Change | 7 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | No Change | 3 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 3 Classes | 0 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 1 Class | 10 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 1 Class | 1 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 3 Classes | 0 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 1 Class | 13 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 1 Class | 3 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 2 Classes | 4 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 1 Class | 12 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 1 Class | 0 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 2 Classes | 1 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | No Change | 4 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 3 Classes | 0 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 2 Classes | 4 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 1 Class | 17 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 3 Classes | 9 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 2 Classes | 289 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | No Change | 230 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Worsened 1 Class | 62 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 1 Class | 382 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 2 Classes | 282 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | Improved 2 Classes | 86 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 1 Class | 486 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 1 Class | 18 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | Discharge up to 30 days | No Change | 337 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Worsened 2 Classes | 0 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Worsened 3 Classes | 0 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 1 Year | Improved 3 Classes | 13 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 1 Class | 525 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | No Change | 236 Participants |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | 3-6 Months | Improved 3 Classes | 12 Participants |
Primary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Time frame: Discharge (up to 30 days), 3-6 months, and 1 year post-implant
Population: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 3-6 Months | 0.71 cm^2/m^2 | Standard Deviation 0.17 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 1 Year | 0.63 cm^2/m^2 | Standard Deviation 0.14 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.71 cm^2/m^2 | Standard Deviation 0.16 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 1 Year | 0.70 cm^2/m^2 | Standard Deviation 0.15 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 3-6 Months | 0.72 cm^2/m^2 | Standard Deviation 0.16 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.74 cm^2/m^2 | Standard Deviation 0.18 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.81 cm^2/m^2 | Standard Deviation 0.2 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 1 Year | 0.76 cm^2/m^2 | Standard Deviation 0.18 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 3-6 Months | 0.79 cm^2/m^2 | Standard Deviation 0.17 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 1 Year | 0.78 cm^2/m^2 | Standard Deviation 0.17 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 3-6 Months | 0.81 cm^2/m^2 | Standard Deviation 0.17 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.81 cm^2/m^2 | Standard Deviation 0.19 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 3-6 Months | 0.90 cm^2/m^2 | Standard Deviation 0.22 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 1 Year | 0.82 cm^2/m^2 | Standard Deviation 0.17 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.89 cm^2/m^2 | Standard Deviation 0.23 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 3-6 Months | 1.16 cm^2/m^2 | Standard Deviation 0.31 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | Discharge (up to 30 days) | 1.07 cm^2/m^2 | Standard Deviation 0.3 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 1 Year | 1.14 cm^2/m^2 | Standard Deviation 0.28 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | Discharge (up to 30 days) | 0.81 cm^2/m^2 | Standard Deviation 0.2 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 3-6 Months | 0.80 cm^2/m^2 | Standard Deviation 0.19 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | 1 Year | 0.76 cm^2/m^2 | Standard Deviation 0.18 |
Primary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year
A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Time frame: Measured at discharge (up to 30 days), 3-6 months, and 1 year post-implant
Population: At each timepoint, only subjects with echocardiography core lab data are included in the rows below.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 1 Year | 30.4 mmHg | Standard Deviation 8.2 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 3-6 Months | 27.2 mmHg | Standard Deviation 6.7 |
| Medtronic Avalus Valve 19mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | Discharge (up to 30 days) | 32.2 mmHg | Standard Deviation 9.7 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 3-6 Months | 26.3 mmHg | Standard Deviation 8.6 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | Discharge (up to 30 days) | 28.0 mmHg | Standard Deviation 9.2 |
| Medtronic Avalus Valve 21mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 1 Year | 27.8 mmHg | Standard Deviation 9.4 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 1 Year | 23.1 mmHg | Standard Deviation 7.5 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | Discharge (up to 30 days) | 23.6 mmHg | Standard Deviation 8 |
| Medtronic Avalus Valve 23mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 3-6 Months | 21.6 mmHg | Standard Deviation 6.8 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 3-6 Months | 21.1 mmHg | Standard Deviation 7.2 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | Discharge (up to 30 days) | 22.4 mmHg | Standard Deviation 6.8 |
| Medtronic Avalus Valve 25mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 1 Year | 22.0 mmHg | Standard Deviation 7.3 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 3-6 Months | 17.7 mmHg | Standard Deviation 5.9 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | Discharge (up to 30 days) | 19.6 mmHg | Standard Deviation 6.8 |
| Medtronic Avalus Valve 27mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 1 Year | 19.0 mmHg | Standard Deviation 6.7 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | Discharge (up to 30 days) | 16.2 mmHg | Standard Deviation 6.3 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 1 Year | 18.1 mmHg | Standard Deviation 6.5 |
| Medtronic Avalus Valve 29mm | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 3-6 Months | 14.7 mmHg | Standard Deviation 6.3 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 1 Year | 23.5 mmHg | Standard Deviation 8.3 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | 3-6 Months | 22.1 mmHg | Standard Deviation 7.7 |
| Medtronic Avalus Valve (17mm - 29mm) | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | Discharge (up to 30 days) | 23.9 mmHg | Standard Deviation 8.4 |
Primary
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant
Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The incidence rates will be used to summarize valve-related adverse events and death.
Time frame: 1 year post-implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Severe hemodynamic dysfunction - indeterminate or evolving cause | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Reintervention | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major hemorrhage | 7.1 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Explant | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All paravalvular leak | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Structural valve deterioration | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Hemolysis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Non-structural valve dysfunction | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve- related death | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All death | 9.5 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major paravalvular leak | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve thrombosis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All hemorrhage | 7.1 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Endocarditis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 19mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Thromboembolism | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All hemorrhage | 3.8 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All paravalvular leak | 0.5 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Thromboembolism | 2.8 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Reintervention | 0.9 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve thrombosis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Severe hemodynamic dysfunction - indeterminate or evolving cause | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major hemorrhage | 0.5 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Structural valve deterioration | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Hemolysis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Non-structural valve dysfunction | 0.5 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Endocarditis | 0.5 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve- related death | 0.9 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All death | 2.8 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major paravalvular leak | 0.5 percentage of participants with event |
| Medtronic Avalus Valve 21mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Explant | 0.9 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Explant | 1.2 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Severe hemodynamic dysfunction - indeterminate or evolving cause | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Reintervention | 1.2 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major paravalvular leak | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Thromboembolism | 2.7 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All paravalvular leak | 0.5 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve- related death | 0.2 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve thrombosis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Non-structural valve dysfunction | 0.5 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All hemorrhage | 6.7 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Hemolysis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major hemorrhage | 5.0 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All death | 2.2 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Endocarditis | 1.5 percentage of participants with event |
| Medtronic Avalus Valve 23mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Structural valve deterioration | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major paravalvular leak | 0.3 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All death | 2.9 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Structural valve deterioration | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve- related death | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Thromboembolism | 2.9 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve thrombosis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All hemorrhage | 4.3 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major hemorrhage | 3.4 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All paravalvular leak | 0.6 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Endocarditis | 1.4 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Hemolysis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Non-structural valve dysfunction | 0.6 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Severe hemodynamic dysfunction - indeterminate or evolving cause | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Reintervention | 0.6 percentage of participants with event |
| Medtronic Avalus Valve 25mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Explant | 0.6 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All hemorrhage | 7.9 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All paravalvular leak | 1.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Endocarditis | 1.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major paravalvular leak | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Non-structural valve dysfunction | 1.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All death | 4.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major hemorrhage | 5.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Explant | 1.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Reintervention | 1.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Severe hemodynamic dysfunction - indeterminate or evolving cause | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve thrombosis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Structural valve deterioration | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Thromboembolism | 4.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Hemolysis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 27mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve- related death | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All paravalvular leak | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All death | 3.8 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve- related death | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Hemolysis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Endocarditis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Non-structural valve dysfunction | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major paravalvular leak | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Structural valve deterioration | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve thrombosis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Severe hemodynamic dysfunction - indeterminate or evolving cause | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Thromboembolism | 3.8 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Explant | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Reintervention | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major hemorrhage | 0.0 percentage of participants with event |
| Medtronic Avalus Valve 29mm | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All hemorrhage | 0.0 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Explant | 0.9 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve- related death | 0.3 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major hemorrhage | 3.6 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Severe hemodynamic dysfunction - indeterminate or evolving cause | 0.0 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Thromboembolism | 2.8 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Major paravalvular leak | 0.2 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Non-structural valve dysfunction | 0.5 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All hemorrhage | 5.4 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All death | 3.0 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Hemolysis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Structural valve deterioration | 0.0 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | All paravalvular leak | 0.5 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Valve thrombosis | 0.0 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Reintervention | 0.9 percentage of participants with event |
| Medtronic Avalus Valve (17mm - 29mm) | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Endocarditis | 1.1 percentage of participants with event |
Secondary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 5 Years Post-implant
Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Secondary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 5 Years Post-implant
Cardiac output is the amount of blood pumped by the heart per minute, evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Secondary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 5 Years Post-procedure
Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Secondary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 5 Years Post-implant
Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Secondary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 5 Years Post-implant
Performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Secondary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 5 Years Post-implant
At each timepoint, participants were evaluated for change in New York Heart Association (NYHA) functional classification from baseline through 5 years post-procedure. 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: Annually, at years 2, 3, 4, and 5 post-implant
Secondary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 5 Years Post-implant
Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Secondary
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 5 Years Post-implant
Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Secondary
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death Annually Through 5 Years Post-implant
Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. The Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval.
Time frame: Annually, at years 2, 3, 4, and 5 post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve by Clinically Acceptable Hemodynamic Performance From Years 6 Through 12 Post-implant.
Long-term follow-up clinically acceptable hemodynamic performance defined as freedom from surgical explant and/or percutaneous valve-in-valve reintervention due to structural valve deterioration
Time frame: Annually, years 6-12 post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Change in NYHA Functional Classification Status From Baseline
Time frame: Annually, years 6 though 12 post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Freedom From All-cause Mortality
For time-to-event outcomes, Kaplan-Meier (actuarial) analysis of the event-free rate performed annually through twelve years.
Time frame: Annually, years 6 though 12 post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Freedom From Valve-related Death
Time frame: Annually, years 6 though 12 post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 12 Years Post-implant
Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.
Time frame: Annually, years 6 though 12 post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.
Time frame: 3-6 months, and 1 year post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 12 Years Post-implant
Cardiac output is the amount of blood pumped by the heart per minute. Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.
Time frame: Annually, years 6 though 12 post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
Cardiac output is the amount of blood pumped by the heart per minute. Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.
Time frame: 3-6 months, and 1 year post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 12 Years Post-procedure
Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Time frame: Annually, years 6 though 12 post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Time frame: 3-6 months, 1 year post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 12 Years Post-implant
Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Time frame: Annually, years 6 though 12 post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Time frame: 3-6 months, and 1 year post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 12 Years Post-implant
Performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Time frame: Annually, years 6 though 12 post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
Performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Time frame: 3-6 months, and 1 year post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
Participants evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure. 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: 3-6 months and 1 year post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 12 Years Post-implant
Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Time frame: Annually, years 6 though 12 post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Time frame: 3-6 months, and 1 year post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Time frame: 3-6 months, and 1 year post-implant
Other Pre-specified
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) up to 12 Years Post-implant
Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Time frame: Annually, years 6 though 12 post-implant
Other Pre-specified
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)
Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval.
Time frame: 1 year post-implant