To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patient has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
i. Left atrial appendage (LAA) ligation ii. CABG (coronary artery bypass grafting) iii. Patent foramen ovale (PFO) closure iv. Ascending aortic aneurysm or dissection repair not requiring circulatory arrest v. Resection of a sub-aortic membrane not requiring myectomy
2. Patient is geographically stable and willing to return to the implanting site for all follow-up visits
3. Patient is of legal age to provide informed consent in the country where they enroll in the trial
4. Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial
Exclusion Criteria:
1. Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
2. Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis
3. Patient presents with active endocarditis, active myocarditis or other systemic infection
4. Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:
* Ascending aortic aneurysm or dissection repair requiring circulatory arrest
* Acute Type A aortic dissection
* Ventricular aneurysm
* Porcelain aorta
* Hostile mediastinum
* Hypertrophic obstructive cardiomyopathy (HOCM)
* Documented pulmonary hypertension (systolic \>60mmHg)
5. Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to:
* Child-Pugh Class C liver disease
* Terminal cancer
* End-stage lung disease
6. Patient has renal failure, defined as dialysis therapy or glomerular filtration rate(GFR)\<30 mL/min/1.73 m2
7. Patient has hyperparathyroidism
8. Patient is participating in another investigational device or drug trial or observational competitive study
9. Patient is pregnant, lactating or planning to become pregnant during the trial period
10. Patient has a documented history of substance (drug or alcohol) abuse
11. Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography
12. Patient has systolic ejection fraction (EF)\<20% as assessed by echocardiography
13. Patient has Grade IV Diastolic Dysfunction
14. Patient has documented bleeding diatheses
15. Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment
16. Patient requires emergency surgery
Primary outcome measure(s)
Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant — 1 year post-implant Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The incidence rates will be used to summarize valve-related adverse events and death.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year — Discharge (up to 30 days), 3-6 months, and 1 year post-implant At each timepoint, a minimum of 15 participants per valve size evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure.
Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure — Discharge (up to 30 days), 3-6 months, 1 year post-implant A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant — Discharge (up to 30 days), 3-6 months, and 1 year post-implant A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm\^2 divided by body surface area (BSA) in m\^2.
The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year — Measured at discharge (up to 30 days), 3-6 months, and 1 year post-implant A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.
The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant — Discharge (up to 30 days), 3-6 months, and 1 year post-implant A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant — Discharge (up to 30 days), 3-6 months, and 1 year post-implant A minimum of 15 participants per valve size will have performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant — Discharge (up to 30 days), 3-6 months, and 1 year post-implant Cardiac output is the amount of blood pumped by the heart per minute. A minimum of 15 participants per valve size were evaluated for this outcome measure by transthoracic echocardiography technique and assessed by an independent core laboratory.
Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant — Discharge (up to 30 days), 3-6 months, and 1 year post-implant A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area.
Trial sites (38)
Facility
City
Region
Status
University of Southern California (USC) University Hospital
Los Angeles
California
University of Colorado Hospital
Aurora
Colorado
Hartford Hospital
Hartford
Connecticut
University of Florida Shands
Gainesville
Florida
Piedmont Hospital
Atlanta
Georgia
University of Maryland Medical Center
Baltimore
Maryland
Massachusetts General Hospital
Boston
Massachusetts
University of Michigan Cardiovascular Center
Ann Arbor
Michigan
Minneapolis Heart Institute Foundation
Minneapolis
Minnesota
Maimonides Medical Center
Brooklyn
New York
The Mount Sinai Medical Center
New York
New York
New York-Presbyterian Hospital/Columbia University Medical Center
New York
New York
Cleveland Clinic
Cleveland
Ohio
Riverside Methodist Hospital (OhioHealth)
Columbus
Ohio
ProMedica Toledo Hospital
Toledo
Ohio
Oklahoma Heart Hospital
Oklahoma City
Oklahoma
Cardiothoracic and Vascular Surgeons (CTVS)
Austin
Texas
Houston Methodist Hospital
Houston
Texas
University of Washington Medical Center
Seattle
Washington
Aurora Saint Luke's Medical Center
Milwaukee
Wisconsin
London Health Sciences Centre - University Campus
London
Ontario
University of Ottawa Heart Institute
Ottawa
Ontario
Montreal Heart Institute
Montreal
Quebec
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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