Behavior of Valve Leaflets Following Aortic Valve Implant

Not Applicable

Completed

Conditions: Aortic-valve Replacement

Interventions: Diagnostic Test: 4D Cardiac CT Scan
Device: LivaNova Bioprothetic Aortic Valve Implant

Registration Number: NCT03200574

Lead Sponsor: Corcym S.r.l

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 88

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aortic Valve	LivaNova Bioprothetic Aortic Valve Implant	LivaNova bioprosthetic aortic heart valve replacement
Aortic Valve	4D Cardiac CT Scan	LivaNova bioprosthetic aortic heart valve replacement

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
Freedom From Valve Re-intervention	up to 1 year post-implant	Number and incidence of subjects free from valve reintervention
Freedom From Valve Thrombosis	up to 1 year post-implant	Number and incidence of subjects free from valve thrombosis
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 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)
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)
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).
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 Myocardial Infarction	up to 1 year post-implant	Number and incidence of subjects free from myocardial infarction
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
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)
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)
Freedom From Structural Valve Deterioration	up to 1 year post-implant	Number and incidence of subjects free from structural valve deterioration
Freedom From Valve Endocarditis	up to 1 year post-implant	Number and incidence of subjects free from valve endocarditis
Freedom From Thromboembolic Events	up to 1 year post-implant	Number and incidence of subjects free from thromboembolic events
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
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)
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)

Trial Locations

Locations (11): St. Vincent Cardiovascular Research Institute
🇺🇸
Indianapolis, Indiana, United States
Maine Medical Center
🇺🇸
Scarborough, Maine, United States
St. Michael's Hospital
🇨🇦
Toronto, Ontario, Canada
Missouri Baptist Hospital
🇺🇸
Saint Louis, Missouri, United States
Valley Health
🇺🇸
Winchester, Virginia, United States
Montreal Heart Institute
🇨🇦
Montréal, Quebec, Canada
Universite Laval
🇨🇦
Québec, Quebec, Canada
Oakwood Hospital
🇺🇸
Dearborn, Michigan, United States
Washington Adventist Hospital
🇺🇸
Takoma Park, Maryland, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Centennial
🇺🇸
Nashville, Tennessee, United States