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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy
Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, United States
Maine Medical Center
Scarborough, Maine, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
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
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
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
Reduction in Leaflet Motion by Relationship to Devices or Procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oakwood Hospital
Dearborn, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Missouri Baptist Hospital
St Louis, Missouri, United States
Centennial
Nashville, Tennessee, United States
Valley Health
Winchester, Virginia, United States
St. Michael's Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
...and 1 more locations
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
Freedom From All-cause Mortality
Number and incidence of subjects free from all-cause mortality
Time frame: up to 1 year post-implant
Freedom From Valve Re-intervention
Number and incidence of subjects free from valve reintervention
Time frame: up to 1 year post-implant
Freedom From Myocardial Infarction
Number and incidence of subjects free from myocardial infarction
Time frame: up to 1 year post-implant
Freedom From Structural Valve Deterioration
Number and incidence of subjects free from structural valve deterioration
Time frame: 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
Time frame: up to 1 year post-implant
Freedom From Valve Endocarditis
Number and incidence of subjects free from valve endocarditis
Time frame: up to 1 year post-implant
Freedom From Valve Thrombosis
Number and incidence of subjects free from valve thrombosis
Time frame: up to 1 year post-implant
Freedom From Thromboembolic Events
Number and incidence of subjects free from thromboembolic events
Time frame: up to 1 year post-implant
Freedom From Hemolysis
Number and incidence of subjects free from hemolysis
Time frame: up to 1 year post-implant
Freedom From Major Bleeding
Number and incidence of subjects free from major bleeding
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: up to 1 year post-implant