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Active, Not Recruiting

NCT Number: NCT02088554

PERIGON Pivotal Trial

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre - University Campus, London, Ontario, Canada

Loading trial locations.

About this study

This is a prospective, interventional, non-randomized, worldwide, multi-center trial. A maximum of 1300 subjects were to be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial includes male and female patients of legal age to provide informed consent in the country where they enrolled in the trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Subjects are followed out to 5 years, and select sites follow subjects out to 12 years. Enrollment closed on 14Jul2017 for all valve sizes. Enrollment was reopened in Apr2019 for the 29mm valve size at a subset of US and Canadian sites to obtain greater patient numbers required by the FDA to support US commercial approval of this valve size. Enrollment for the 29mm valve size closed on 14Feb2023.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Patient is geographically stable and willing to return to the implanting site for all follow-up visits
  • Patient is of legal age to provide informed consent in the country where they enroll in the trial
  • 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

  • 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
  • Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis
  • Patient presents with active endocarditis, active myocarditis or other systemic infection
  • 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)
  • 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
  • Patient has renal failure, defined as dialysis therapy or glomerular filtration rate(GFR)<30 mL/min/1.73 m2
  • Patient has hyperparathyroidism
  • Patient is participating in another investigational device or drug trial or observational competitive study
  • Patient is pregnant, lactating or planning to become pregnant during the trial period
  • Patient has a documented history of substance (drug or alcohol) abuse
  • Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography
  • Patient has systolic ejection fraction (EF)<20% as assessed by echocardiography
  • Patient has Grade IV Diastolic Dysfunction
  • Patient has documented bleeding diatheses
  • Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment
  • Patient requires emergency surgery

Treatment and study plan

Model 400 aortic valve bioprosthesis

Device

Primary outcomes

  1. Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant

    Time frame: 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.

  2. 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

    Time frame: 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.

  3. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure

    Time frame: 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.

  4. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant

    Time frame: 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.

  5. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year

    Time frame: 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.

  6. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant

    Time frame: 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.

  7. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant

    Time frame: 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.

  8. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant

    Time frame: 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.

  9. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant

    Time frame: 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.

Secondary outcomes

  1. Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death Annually Through 5 Years Post-implant

    Time frame: Annually, at years 2, 3, 4, and 5 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. The Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval.

  2. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 5 Years Post-implant

    Time frame: Annually, at years 2, 3, 4, and 5 post-implant

    At each timepoint, participants were evaluated for change in New York Heart Association (NYHA) functional classification from baseline through 5 years 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.

  3. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 5 Years Post-procedure

    Time frame: Annually, at years 2, 3, 4, and 5 post-implant

    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.

  4. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 5 Years Post-implant

    Time frame: Annually, at years 2, 3, 4, and 5 post-implant

    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.

  5. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 5 Years Post-implant

    Time frame: Annually, at years 2, 3, 4, and 5 post-implant

    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.

  6. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 5 Years Post-implant

    Time frame: Annually, at years 2, 3, 4, and 5 post-implant

    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.

  7. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 5 Years Post-implant

    Time frame: Annually, at years 2, 3, 4, and 5 post-implant

    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.

  8. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 5 Years Post-implant

    Time frame: Annually, at years 2, 3, 4, and 5 post-implant

    Cardiac output is the amount of blood pumped by the heart per minute, evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.

  9. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 5 Years Post-implant

    Time frame: Annually, at years 2, 3, 4, and 5 post-implant

    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.

Other outcomes

  1. Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)

    Time frame: 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 Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval.

  2. 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 (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)

    Time frame: 3-6 months and 1 year post-implant

    Participants 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.

  3. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)

    Time frame: 3-6 months, 1 year post-implant

    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.

  4. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)

    Time frame: 3-6 months, and 1 year post-implant

    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.

  5. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)

    Time frame: 3-6 months, and 1 year post-implant

    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.

  6. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)

    Time frame: 3-6 months, and 1 year post-implant

    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.

  7. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)

    Time frame: 3-6 months, and 1 year post-implant

    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.

  8. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)

    Time frame: 3-6 months, and 1 year post-implant

    Cardiac output is the amount of blood pumped by the heart per minute. Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.

  9. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes)

    Time frame: 3-6 months, and 1 year post-implant

    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.

  10. Confirm the Effectiveness of the Model 400 Avalus Valve by Clinically Acceptable Hemodynamic Performance From Years 6 Through 12 Post-implant.

    Time frame: Annually, years 6-12 post-implant

    Long-term follow-up clinically acceptable hemodynamic performance defined as freedom from surgical explant and/or percutaneous valve-in-valve reintervention due to structural valve deterioration

  11. Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Freedom From Valve-related Death

    Time frame: Annually, years 6 though 12 post-implant

  12. Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Freedom From All-cause Mortality

    Time frame: Annually, years 6 though 12 post-implant

    For time-to-event outcomes, Kaplan-Meier (actuarial) analysis of the event-free rate performed annually through twelve years.

  13. Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Change in NYHA Functional Classification Status From Baseline

    Time frame: Annually, years 6 though 12 post-implant

  14. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 12 Years Post-procedure

    Time frame: Annually, years 6 though 12 post-implant

    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.

  15. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 12 Years Post-implant

    Time frame: Annually, years 6 though 12 post-implant

    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.

  16. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) up to 12 Years Post-implant

    Time frame: Annually, years 6 though 12 post-implant

    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.

  17. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 12 Years Post-implant

    Time frame: Annually, years 6 though 12 post-implant

    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.

  18. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 12 Years Post-implant

    Time frame: Annually, years 6 though 12 post-implant

    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.

  19. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 12 Years Post-implant

    Time frame: Annually, years 6 though 12 post-implant

    Cardiac output is the amount of blood pumped by the heart per minute. Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory.

  20. Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 12 Years Post-implant

    Time frame: Annually, years 6 though 12 post-implant

    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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Surgery

Industry

Collaborators

  • Medtronic

Registry information

Official study title

Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease

Acronym: PERIGON

Important dates

Study start
2014
Primary completion
2023
Study completion
2035
First posted
Mar 17, 2014
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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