PERIGON Pivotal Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Study summary

To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

Eligibility

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)

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