Aortic-valve Replacement
Conditions
Keywords
Perceval
Brief summary
This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.
Detailed description
This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant, on patients that are off anticoagulation for at least 30 days. A minimum of 75 subjects with evaluable 4D CT scans will be enrolled at approximately 11 investigational sites where the devices are commercially available. For asymptomatic subjects, PIs and subjects will be blinded from the CT imaging results and from the Core Lab findings.
Interventions
DIAGNOSTIC_TEST4D Cardiac CT Scan
4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy
DEVICELivaNova Bioprothetic Aortic Valve Implant
Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.
Sponsors
LivaNova
Corcym S.r.l
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-center trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject has been successfully implanted with a commercially approved LivaNova bioprosthetic valve according to the instructions for use (IFU) 2. The subject has signed the informed consent. 3. The subject is at least 18 years of age at the time of implant and consent signature 4. The subject will be available for post-operative follow-up through one year
Exclusion criteria
1. The subject has a planned concomitant cardiac procedure other than coronary artery bypass graft (CABG) and septal myectomy, including MAZE procedures, atrial fibrillation surgery, and left atrial appendage exclusion or resection, or has a prosthetic heart valve or annuloplasty ring in any position 2. The subject has any medical condition requiring long term (\> 6 months) anticoagulation or dual antiplatelet therapy 3. The subject has any clinical condition precluding the use of CT imaging with contrast 4. The subject had a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days of the planned valve implant surgery 5. The subject has active endocarditis, myocarditis, or sepsis 6. The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support 7. The subject is already included in another clinical trial that could confound the results of this clinical investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Leaflet Motion | 1 year post-implant | Report the overall incidence of reduced leaflet motion identified by CT imaging in commercially approved LivaNova bioprosthetic aortic heart valves up to 1 year post implant on patients that are off anticoagulation for at least 30 days. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (\<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (\>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Valve Thrombosis | up to 1 year post-implant | Number and incidence of subjects free from valve thrombosis |
| Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes | up to 1 year post-implant | Incidence of reduced leaflet motion in symptomatic and asymptomatic subjects based on CT outcomes and anticoagulation and dual antiplatelet treatment modalities up to 1 year post-implant. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (\<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (\>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion). |
| Reduced Leaflet Motion Through 4D Volume-rendered CT Scan | up to 1 year post-implant | Incidence of reduced leaflet motion through 4D volume-rendered CT scan with contrast up to 1 year post-implant, in subjects in which reduced leaflet motion was previously detected. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (\<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (\>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion). |
| Reduction in Leaflet Motion by Relationship to Devices or Procedure | up to 1 year post-implant | Incidence of reduced leaflet motion considering relationship to the devices, procedure, or other causes up to 1 year post-implant The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (\<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (\>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion). |
| Freedom From All-cause Mortality | up to 1 year post-implant | Number and incidence of subjects free from all-cause mortality |
| Freedom From Valve Re-intervention | up to 1 year post-implant | Number and incidence of subjects free from valve reintervention |
| Freedom From Myocardial Infarction | up to 1 year post-implant | Number and incidence of subjects free from myocardial infarction |
| Freedom From Structural Valve Deterioration | up to 1 year post-implant | Number and incidence of subjects free from structural valve deterioration |
| Freedom From Moderate or Severe Valve Regurgitation | up to 1 year post-implant | Number and incidence of subjects free from moderate or severe valve regurgitation |
| Freedom From Valve Endocarditis | up to 1 year post-implant | Number and incidence of subjects free from valve endocarditis |
| Freedom From Hemolysis | up to 1 year post-implant | Number and incidence of subjects free from hemolysis |
| Freedom From Major Bleeding | up to 1 year post-implant | Number and incidence of subjects free from major bleeding |
| New York Heart Association (NYHA) Assessment | 1 year post-implant | Number and incidence of subjects in the different NYHA class at 1 year post-implant. NYHA I = Subjects with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina. NYHA II = Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina. NYHA III = Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina. NYHA IV = Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or angina may be present even at rest. If any physical activity is undertaken, discomfort is increased. |
| Aortic Peak Gradient Through Transthoracic Echocardiogram (TTE) | up to 1 year post-implant | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) |
| Aortic Mean Gradient Through Transthoracic Echocardiogram (TTE) | up to 1 year post-implant | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) |
| Effective Orifice Area Through Transthoracic Echocardiogram (TTE) | up to 1 year post-implant | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) |
| Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | up to 1 year post-implant | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) |
| Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | up to 1 year post-implant | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) |
| Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | up to 1 year post-implant | Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE) |
| Freedom From Thromboembolic Events | up to 1 year post-implant | Number and incidence of subjects free from thromboembolic events |
Countries
Canada, United States
Participant flow
Recruitment details
88 subjects undergoing AVR with the commercially available Perceval S Valve (Manufacturer Livanova, now transitioned to Corcym), having signed informed consent and willing and able to undergo 4D CT assessments with contrast (or alternatively TEE) were enrolled in the study. The study was forseeing 24 month of enrollment and 1 Year follow-up. The first enrolment occured on on August 12, 2017, and the last enrollment on May 22, 2019 in a total of 10 clinical study sites.
Participants by arm
| Arm | Count |
|---|---|
| Aortic Valve LivaNova bioprosthetic aortic heart valve replacement
4D Cardiac CT Scan: 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy
LivaNova Bioprothetic Aortic Valve Implant: Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care. | 88 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Long-Term need for anticoagulation | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Relocation | 2 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Aortic Valve |
|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 88 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 38 / 88 |
Outcome results
Primary
Reduction in Leaflet Motion
Report the overall incidence of reduced leaflet motion identified by CT imaging in commercially approved LivaNova bioprosthetic aortic heart valves up to 1 year post implant on patients that are off anticoagulation for at least 30 days. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (\<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (\>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion).
Time frame: 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Reduction in Leaflet Motion | 12 Participants |
Secondary
Aortic Mean Gradient Through Transthoracic Echocardiogram (TTE)
Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE)
Time frame: up to 1 year post-implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve | Aortic Mean Gradient Through Transthoracic Echocardiogram (TTE) | 12.5 mmHg | Standard Deviation 5.9 |
Secondary
Aortic Peak Gradient Through Transthoracic Echocardiogram (TTE)
Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE)
Time frame: up to 1 year post-implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve | Aortic Peak Gradient Through Transthoracic Echocardiogram (TTE) | 22.6 mmHg | Standard Deviation 9.6 |
Secondary
Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)
Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE)
Time frame: up to 1 year post-implant
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve | Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Mild | 5 Participants |
| Aortic Valve | Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | None | 60 Participants |
| Aortic Valve | Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Trace | 2 Participants |
| Aortic Valve | Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Not evaluable | 1 Participants |
Secondary
Effective Orifice Area Through Transthoracic Echocardiogram (TTE)
Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE)
Time frame: up to 1 year post-implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aortic Valve | Effective Orifice Area Through Transthoracic Echocardiogram (TTE) | 1.7 cm2 | Standard Deviation 0.5 |
Secondary
Freedom From All-cause Mortality
Number and incidence of subjects free from all-cause mortality
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Freedom From All-cause Mortality | 84 Participants |
Secondary
Freedom From Hemolysis
Number and incidence of subjects free from hemolysis
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Freedom From Hemolysis | 88 Participants |
Secondary
Freedom From Major Bleeding
Number and incidence of subjects free from major bleeding
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Freedom From Major Bleeding | 85 Participants |
Secondary
Freedom From Moderate or Severe Valve Regurgitation
Number and incidence of subjects free from moderate or severe valve regurgitation
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Freedom From Moderate or Severe Valve Regurgitation | 88 Participants |
Secondary
Freedom From Myocardial Infarction
Number and incidence of subjects free from myocardial infarction
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Freedom From Myocardial Infarction | 88 Participants |
Secondary
Freedom From Structural Valve Deterioration
Number and incidence of subjects free from structural valve deterioration
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Freedom From Structural Valve Deterioration | 88 Participants |
Secondary
Freedom From Thromboembolic Events
Number and incidence of subjects free from thromboembolic events
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Freedom From Thromboembolic Events | 82 Participants |
Secondary
Freedom From Valve Endocarditis
Number and incidence of subjects free from valve endocarditis
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Freedom From Valve Endocarditis | 88 Participants |
Secondary
Freedom From Valve Re-intervention
Number and incidence of subjects free from valve reintervention
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Freedom From Valve Re-intervention | 88 Participants |
Secondary
Freedom From Valve Thrombosis
Number and incidence of subjects free from valve thrombosis
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Freedom From Valve Thrombosis | 87 Participants |
Secondary
Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)
Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE)
Time frame: up to 1 year post-implant
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve | Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Trace | 4 Participants |
| Aortic Valve | Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | No regurgitation | 51 Participants |
| Aortic Valve | Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Mild | 9 Participants |
| Aortic Valve | Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Moderate | 1 Participants |
| Aortic Valve | Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Not evaluable | 3 Participants |
Secondary
Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes
Incidence of reduced leaflet motion in symptomatic and asymptomatic subjects based on CT outcomes and anticoagulation and dual antiplatelet treatment modalities up to 1 year post-implant. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (\<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (\>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion).
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes | 11 Participants |
| Symtomatic Patients | Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes | 1 Participants |
Secondary
New York Heart Association (NYHA) Assessment
Number and incidence of subjects in the different NYHA class at 1 year post-implant. NYHA I = Subjects with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina. NYHA II = Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina. NYHA III = Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina. NYHA IV = Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or angina may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 1 year post-implant
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve | New York Heart Association (NYHA) Assessment | NYHA class I | 52 Participants |
| Aortic Valve | New York Heart Association (NYHA) Assessment | NYHA class II | 17 Participants |
| Aortic Valve | New York Heart Association (NYHA) Assessment | NYHA Class III | 0 Participants |
| Aortic Valve | New York Heart Association (NYHA) Assessment | NYHA class IV | 0 Participants |
Secondary
Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)
Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE)
Time frame: up to 1 year post-implant
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aortic Valve | Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | None | 60 Participants |
| Aortic Valve | Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Trace | 1 Participants |
| Aortic Valve | Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Mild | 6 Participants |
| Aortic Valve | Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) | Not evaluable | 1 Participants |
Secondary
Reduced Leaflet Motion Through 4D Volume-rendered CT Scan
Incidence of reduced leaflet motion through 4D volume-rendered CT scan with contrast up to 1 year post-implant, in subjects in which reduced leaflet motion was previously detected. The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (\<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (\>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion).
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Reduced Leaflet Motion Through 4D Volume-rendered CT Scan | 2 Participants |
Secondary
Reduction in Leaflet Motion by Relationship to Devices or Procedure
Incidence of reduced leaflet motion considering relationship to the devices, procedure, or other causes up to 1 year post-implant The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (\<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (\>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion).
Time frame: up to 1 year post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aortic Valve | Reduction in Leaflet Motion by Relationship to Devices or Procedure | 12 Participants |
| Symtomatic Patients | Reduction in Leaflet Motion by Relationship to Devices or Procedure | 1 Participants |
| Subjects Implanted With Perceval S Size M | Reduction in Leaflet Motion by Relationship to Devices or Procedure | 3 Participants |
| Subjects Implanted With Perceval S Size L | Reduction in Leaflet Motion by Relationship to Devices or Procedure | 4 Participants |
| Subjects Implanted With Perceval Size XL | Reduction in Leaflet Motion by Relationship to Devices or Procedure | 4 Participants |
| Subjects Implanted With Perceval Via Minimally Invasive Surgical Approach | Reduction in Leaflet Motion by Relationship to Devices or Procedure | 5 Participants |
| Subjects Implanted With Perceval Via Full Sternotomy Surgical Approach | Reduction in Leaflet Motion by Relationship to Devices or Procedure | 7 Participants |