Clinical trial NCT03200574: Behavior of Valve Leaflets Following Aortic Valve Implant
Official title: Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic-valve Replacement
Keywords: Perceval
Lead sponsor: Corcym S.r.l
Sponsor class: INDUSTRY
Collaborators: name: LivaNova
First posted: 2017-06-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in Leaflet Motion
timeFrame: 1 year post-implant
Secondary outcomes:
measure: Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes
timeFrame: up to 1 year post-implant
measure: Reduced Leaflet Motion Through 4D Volume-rendered CT Scan
timeFrame: up to 1 year post-implant
measure: Reduction in Leaflet Motion by Relationship to Devices or Procedure
timeFrame: up to 1 year post-implant
measure: Freedom From All-cause Mortality
timeFrame: up to 1 year post-implant
measure: Freedom From Valve Re-intervention
timeFrame: up to 1 year post-implant
measure: Freedom From Myocardial Infarction
timeFrame: up to 1 year post-implant
measure: Freedom From Structural Valve Deterioration
timeFrame: up to 1 year post-implant
measure: Freedom From Moderate or Severe Valve Regurgitation
timeFrame: up to 1 year post-implant
measure: Freedom From Valve Endocarditis
timeFrame: up to 1 year post-implant
measure: Freedom From Valve Thrombosis
timeFrame: up to 1 year post-implant
measure: Freedom From Thromboembolic Events
timeFrame: up to 1 year post-implant
measure: Freedom From Hemolysis
timeFrame: up to 1 year post-implant
measure: Freedom From Major Bleeding
timeFrame: up to 1 year post-implant
measure: New York Heart Association (NYHA) Assessment
timeFrame: 1 year post-implant
measure: Aortic Peak Gradient Through Transthoracic Echocardiogram (TTE)
timeFrame: up to 1 year post-implant
measure: Aortic Mean Gradient Through Transthoracic Echocardiogram (TTE)
timeFrame: up to 1 year post-implant
measure: Effective Orifice Area Through Transthoracic Echocardiogram (TTE)
timeFrame: up to 1 year post-implant
measure: Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)
timeFrame: up to 1 year post-implant
measure: Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)
timeFrame: up to 1 year post-implant
measure: Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)
timeFrame: up to 1 year post-implant
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: St. Vincent Cardiovascular Research Institute
state: Indiana
city: Scarborough
country: United States
facility: Maine Medical Center
state: Maine
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Dearborn
country: United States
facility: Oakwood Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Missouri Baptist Hospital
state: Missouri
city: Nashville
country: United States
facility: Centennial
state: Tennessee
city: Winchester
country: United States
facility: Valley Health
state: Virginia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Québec
country: Canada
facility: Universite Laval
state: Quebec
Study officials:
affiliation: Washington Adventist Hospital
name: Niv Ad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medstar Health Research Institute
name: Federico Asch, MD
role: PRINCIPAL_INVESTIGATOR
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