Behavior of Valve Leaflets Following Aortic Valve Implant

Study Overview
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Brief Summary
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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
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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.

Official Title
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Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant

Conditions
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Aortic-valve Replacement

Intervention / Treatment
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* Diagnostic Test: 4D Cardiac CT Scan
* Device: LivaNova Bioprothetic Aortic Valve Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject has been successfully implanted with a commercially approved LivaNova bioprosthetic valve according to the instructions for use (IFU) The subject has signed the informed consent. The subject is at least 18 years of age at the time of implant and consent signature The subject will be available for post-operative follow-up through one year Exclusion Criteria: 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 The subject has any medical condition requiring long term (> 6 months) anticoagulation or dual antiplatelet therapy The subject has any clinical condition precluding the use of CT imaging with contrast The subject had a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days of the planned valve implant surgery The subject has active endocarditis, myocarditis, or sepsis The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support The subject is already included in another clinical trial that could confound the results of this clinical investigation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multi-center trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aortic Valve<br>LivaNova bioprosthetic aortic heart valve replacement | Diagnostic Test: 4D Cardiac CT Scan<br>* 4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy<br>Device: LivaNova Bioprothetic Aortic Valve Implant<br>* Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 year post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | up to 1 year post-implant | 
| 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). | up to 1 year post-implant | 
| 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). | up to 1 year post-implant | 
| Freedom From All-cause Mortality | Number and incidence of subjects free from all-cause mortality | up to 1 year post-implant | 
| Freedom From Valve Re-intervention | Number and incidence of subjects free from valve reintervention | up to 1 year post-implant | 
| Freedom From Myocardial Infarction | Number and incidence of subjects free from myocardial infarction | up to 1 year post-implant | 
| Freedom From Structural Valve Deterioration | Number and incidence of subjects free from structural valve deterioration | up to 1 year post-implant | 
| Freedom From Moderate or Severe Valve Regurgitation | Number and incidence of subjects free from moderate or severe valve regurgitation | up to 1 year post-implant | 
| Freedom From Valve Endocarditis | Number and incidence of subjects free from valve endocarditis | up to 1 year post-implant | 
| Freedom From Valve Thrombosis | Number and incidence of subjects free from valve thrombosis | up to 1 year post-implant | 
| Freedom From Thromboembolic Events | Number and incidence of subjects free from thromboembolic events | up to 1 year post-implant | 
| Freedom From Hemolysis | Number and incidence of subjects free from hemolysis | up to 1 year post-implant | 
| Freedom From Major Bleeding | Number and incidence of subjects free from major bleeding | up to 1 year post-implant | 
| 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. | 1 year post-implant | 
| 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) | up to 1 year post-implant | 
| 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) | up to 1 year post-implant | 
| 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) | up to 1 year post-implant | 
| 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) | up to 1 year post-implant | 
| 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) | up to 1 year post-implant | 
| 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) | up to 1 year post-implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perceval